Medical Errors Prevention & Reporting for Dietitians(#107328)

Section I. Course Objectives

Section II. Medical Errors Prevalence & Root Causes

Section III. Medication Errors

Section IV. Building a Culture of Safety

Section V. Academy of Nutrition and Dietetics (AND) Medical Nutrition Therapy Documentation

Section VI. Health Care Organization Accrediting Requirements

Section VII. State Legal Reporting Requirements

Section VIII. Bibliography of Additional Resources

Section IX. Footnotes

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Section I: Course Objectives

Introduction

Newspaper and television stories of catastrophic injuries occurring at the hands of clinicians spotlight the problem of medical error but provide little insight into its nature or magnitude. The prevalence of medical errors in the United States is a significant and ongoing problem. Medical errors are the eighth leading cause of wrongful death in the U.S. In November 1999, the Institute of Medicine (IOM) released a report estimating that as many as 44,000 to 98,000 patients die as the result of medical errors in hospitals each year. The causes of medical errors are many and varied. Medical errors can incorporate mistakes made in medication, surgery, laboratory results and diagnosis to name a few.

The approach to improving patient safety needs to be that of a comprehensive and team nature. There is no one single solution to this on-going problem but rather many solutions and systems that must be in place and working properly to decrease the risk of medical errors once and for all. The focus must not be on blaming individuals but on learning from past errors and preventing future ones. The goal of health care professionals should be to learn the strategies and systems that are currently being put into place and to enable these systems by taking necessary action. It is simply not acceptable for patients to be harmed by a health care system that is there to offer healing and comfort.

The belief is that errors can be prevented or decreased significantly by designing systems that would make it hard for health care personnel to do the wrong thing and make it easier for them to consistently do the right thing. Reducing the risk of medical mistakes will take a huge commitment from all people that work within the health care community including registered dietitians.

The information in this course may be fairly new to many dietitians but non-the-less of vital importance. It is every single person of the patient's health care team that is responsible for his or her overall care. As dietitians we have access to a patient's medical chart therefore have access to vital information. We have direct contact with each patient and to his or her current medical treatment. It is important for dietitians to be a vital part of the health care team and to be a vital part of the team that works together to decrease the risk of medical errors. As dietitians, it is our specific responsibility to pay special attention to prescribed diets, medications that may have a nutritional impact, and other significant nutritional issues as well as other specific issues that we may specialize in that may grasp our attention.

This course summarizes systems that are now being put into place to help decrease the risk of medical errors as well as recommendations that have been made. Dietitians need to make themselves aware of the issues surrounding medical errors and the scope of the problem as well as what is currently being done to correct them.

Course Objectives

The prevalence of medical errors is a significant problem and after completing this course, the dietetics professional will be able to:
  1. Explain the prevalence and root causes of medical errors
  2. Identify the financial cost associated with medical errors
  3. Explain medication errors prevention issues and hospital solutions
  4. Explain the best practices in developing a Culture of Safety
  5. Discuss the 30 Safe Practices recommendations
  6. Define the role of the Registered Dietitian in preventing medical errors
  7. Describe the national patient safety goals
  8. Explain state legal reporting requirements

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Section II: Medical Errors Prevalence & Root Causes

Medical Errors Prevalence

Attention to medical errors escalated since the release of a study from the Institute of Medicine (IOM), To Err is Human, which found that between 44,000 and 98,000 Americans die each year in U.S. hospitals due to preventable medical errors. Hospital errors rank between the fifth and eighth leading cause of death, killing more Americans than breast cancer, traffic accidents or AIDS. Serious medication errors occur in the cases of five to 10 percent of patients admitted to hospitals. These numbers may understate the problem because they do not include preventable deaths due to medical treatments outside of hospitals.

Since the release of the IOM study, there has been greater focus on the quality of healthcare provided in the U.S. Quality experts agree that one of the most common causes of errors is the medical system itself, not the individuals functioning within the system. Publication of the IOM report triggered substantial public and private sector activity, including the formation of the National Patient Safety Foundation by the American Medical Association, the creation of a non-punitive sentinel events reporting system by the Joint Commission for the Accreditation of Healthcare Organizations, and the establishment of new public private partnerships by the Veterans Health Administration and others.

But more than a decade after that scathing report, patients are still plagued by medication errors and wrong diagnoses that lead to unnecessary surgery and chemotherapy. They still have surgery on the wrong body part, and wake up with foreign objects stitched or stapled inside. A 2010 government analysis found that 134,000 Medicare beneficiaries were suffering adverse events every month, many of which were "clearly or likely preventable." A separate five-year study of North Carolina hospitals, published in the New England Journal of Medicine in November 2010, showed that, in 25 percent of all admissions, the medical care harmed patients. And a study published in Health Affairs in April 2011 revealed that the standard methods hospitals use to detect medical errors fail over 90 percent of the time.1

"The more you look for errors, the more you find," said lead researcher Dr. David C. Classen, an associate professor of medicine at the University of Utah. "There is a large opportunity for improvement, despite all the work that's been done," he said. "And we need better measurement systems to assess how we are doing in patient safety."2

One factor in the high number of errors is that hospital patients tend to be sicker than they were years ago, Classen noted. With the advent of outpatient treatment, "the healthier patients are no longer in hospitals," he said. "We have a much more complicated patient mix, more problems, more medications, so there is more room for error," Classen explained.

Medical Errors Terms & Definitions

The Institute of Medicine (IOM) provides definitions of key terms so that a standard framework can be used for discussing issues related to medical errors and patient safety. These terms are defined as follows:3

  • Medical error - the failure to complete a planned action as intended or the use of a wrong plan to achieve an aim. Errors can include problems in practice, products, procedures, and systems.

The Food and Drug Administration (FDA) defines an adverse event as any undesirable experience associated with the use of a medical product in a patient.

  • Adverse event - an injury caused by medical management rather than by the underlying disease or condition of the patient.

The adverse event is deemed SERIOUS and should be reported when the patient outcome is:4

  • Death - Report if the patient's death is suspected as being a direct outcome of the adverse event.
  • Life Threatening - Report if the patient was at substantial risk of dying at the time of the adverse event or if it is suspected that the use or continued use of the product would result in the patient's death.
  • Hospitalization (initial or prolonged) - Report if admission to the hospital or prolongation of a hospital stay is a result of the adverse event.
  • Disability - Report if the adverse event resulted in a significant, persistent, or permanent change, impairment, damage or disruption in the patient's body function/structure, physical activities or quality of life.
  • Congenital Anomaly - Report if there are suspicions that exposure to a medical product prior to conception or during pregnancy resulted in an adverse outcome in the child.
  • Requires Intervention to Prevent Permanent Impairment or Damage - Report if suspected that the use of a medical product resulted in a condition, which required medical or surgical intervention to preclude permanent impairment or damage to a patient.

Where Errors Occur

Errors occur not only in hospitals but in other health care settings, such as physicians' offices, nursing homes, pharmacies, urgent care centers, and care delivered in the home. Unfortunately, very little data exist on the extent of the problem outside of hospitals. The IOM report indicated, however, that many errors are likely to occur outside the hospital. For example, in a recent investigation of pharmacists, the Massachusetts State Board of Registration in Pharmacy estimated that 2.4 million prescriptions are filled improperly each year in the State.

Medical errors happen when something that was planned as a part of medical care doesn't work out properly, or when the wrong plan was used in the first place. Medical errors can occur anywhere in the health care system:

  • Hospitals.
  • Clinics.
  • Outpatient Surgery Centers.
  • Doctors' Offices.
  • Nursing Homes.
  • Pharmacies.
  • Patients' Homes.

Errors can involve:

  • Medicines.
  • Surgery.
  • Diagnosis.
  • Equipment.
  • Lab reports.

They can happen during even the most routine tasks, such as when a hospital patient on a salt-free diet is given a high-salt meal.

Most errors result from problems created by today's complex health care system. But errors also happen when doctors and their patients have problems communicating. For example, a recent study supported by the Agency for Healthcare Research and Quality (AHRQ) found that doctors often do not help their patients make informed decisions. Uninvolved and uninformed patients are less likely to accept the doctor's choice of treatment and less likely to do what they need to do to make the treatment work.

These and other medication errors reported to the FDA may stem from poor communication, misinterpreted handwriting, drug name confusion, lack of employee knowledge, and lack of patient understanding about a drug's directions. "But it's important to recognize that such errors are due to multiple factors in a complex medical system," says Paul Seligman, M.D., director of the FDA's Office of Pharmacoepidemiology and Statistical Science. "In most cases, medication errors can't be blamed on a single person."5

Types of Errors

Most people believe that medical errors usually involve drugs, such as a patient getting the wrong prescription or dosage, or mishandled surgeries, such as amputation of the wrong limb. However, there are many types of medical errors. The following seven categories summarize types of medical errors that can occur:

  1. Medication Errors, such as a patient receiving the wrong drug.
  2. Surgical Error, such as amputating the wrong limb.
  3. Diagnostic error, such as misdiagnosis leading to an incorrect choice of therapy, failure to use an indicated diagnostic test, misinterpretation of test results, and failure to act on abnormal results.
  4. Equipment failure, such as defibrillators with dead batteries or intravenous pumps whose valves are easily dislodged or bumped, causing increased doses of medication over too short a period.
  5. Infections, such as nosocomial and post-surgical wound infections.
  6. Blood transfusion-related injuries, such as a patient receiving an incorrect blood type.
  7. Misinterpretation of other medical orders, such as failing to give a patient a salt-free meal, as ordered by a physician.

A number of the most common errors are described below.

Medication Errors

In some instances, something as simple as poor handwriting on a prescription pad can result in a pharmacist or hospital staff member administering the wrong drug or wrong dosage of the correct drug. Drug interactions have several "filters" before getting to the patient. Both the physician and the issuing pharmacist have an obligation to validate that the prescribed medication will not have an adverse interaction with any of the other medications. Nurses have an obligation to monitor hospital patients for potential adverse drug reactions, and should be free to question if they are aware of any potential bad drug interactions with patient medication. In spite of these precautionary measures, medication errors still occur. Medication errors can cause injury, extend a patient's hospital stay, and at worst result in death. It is estimated that medication errors cause over 7,000 deaths annually.

Surgical Errors

Unfortunately, errors occur all too often during surgery. They range from leaving sponges or instruments inside a patient to performing the wrong surgery. Surgical errors have a number of different sources, including fatigue, miscommunication, or outright recklessness. Surgical errors can cause significant pain and suffering, requiring the need for repeated follow-up surgeries, with each surgery leaving a patient prone to infection and other risks. In the worst case scenario, surgical errors lead to death.

Diagnostic Errors

Diagnostic errors can include either a total failure to diagnose or a wrong diagnosis. A failure to diagnose is sometimes referred to in the medical community as a "No-Fault Error" where the disease is asymptomatic or presents the symptoms of a much more common condition. Systemic errors occur when some aspect of the medical system introduces error into the process. Common example of systemic errors include transcription errors on lab results, poor handling techniques, inadequate equipment, and failure of staff to alert physicians to report results in a timely manner.

Finally, and most commonly, are cognitive errors or poor physician decisions. These bad decisions can be based on bad data collection, bad symptom interpretation, flawed reasoning or incomplete knowledge. These can often be traced back to physicians lacking knowledge outside their specialty, failing to follow diagnostic protocols, or failing to consult specialists early in a treatment cycle. Diagnostic errors often fall on a physician's shoulders, although incorrect or incomplete data from nursing and support staff can be a contributing factor.

Medical Errors Root Causes

According to a variety of sources, the root cause of medical errors is due to the complexity of today's healthcare system.

  • The IOM emphasized that most medical errors are systems related and not attributable to individual negligence or misconduct. The key to reducing medical errors is to focus on improving the systems of delivering care and not to blame individuals. Health care professionals are simply human and, like everyone else, they make mistakes.
  • The FDA reports that many patient deaths and injuries are associated with the use of FDA-regulated medical products within a complex and time-pressured health care system. Reducing the incidence of medical errors can save thousands of lives and billions of dollars.6
  • Donald M. Berwick, president of the Institute for Health Care Improvement has identified the leading cause of medical mistakes as the increasing complexity of health care. His general recommendations were for more simplification and greater standardization, such as the use of bar codes to ensure that the right patient receives the right dose of the right medication.

Additionally there are some specific factors that can increase the prevalence of medical errors.

  • Incomplete patient information (not knowing about patients' allergies, other medicines they are taking, previous diagnoses, and lab results, for example);
  • Unavailable drug information (such as lack of up-to-date warnings);
  • Miscommunication of drug orders, which can involve poor handwriting, confusion between drugs with similar names, misuse of zeroes and decimal points, confusion of metric and other dosing units, and inappropriate abbreviations;
  • Lack of appropriate labeling as a drug is prepared and repackaged into smaller units; and
  • Environmental factors, such as lighting, heat, noise, and interruptions that can distract health professionals from their medical tasks.

Researchers for The Journal of the American Medical Association have identified several issues that have contributed the incidence of medical errors including:

  • Complexity of the health care system
  • Reluctance of doctors to admit errors
  • Lack of leadership
  • Insurance reimbursement system that rewards errors since hospitals can still bill for additional services when patients are injured but often will not pay for practices that reduce those errors

Medical Errors Financial Cost

Medical errors carry a high financial cost. The IOM report estimates that medical errors cost the nation approximately $37.6 billion each year; about $17 billion of those costs are associated with preventable errors. About half of the expenditures for preventable medical errors are for direct health care costs.

The number of estimated deaths from medical errors is greater than the number of deaths from car accidents or breast cancer. Some medical errors make headlines, such as when a surgeon operates on the wrong knee, or if a child dies due to administering the wrong medication. Other errors occur daily and go unnoticed, unreported, and unaddressed by the medical community. Beyond the human cost, the estimated cost to the health care industry ranges from 17 to 29 billion dollars annually, with that cost spread equally between health care and legal settlement costs.

The Institute of Medicine report, Preventing Medication Errors notes that medication errors are undoubtedly costly-to patients, their families, their employers, and to hospitals, health-care providers, and insurance companies-but there are few reliable estimates of that cost. One study found that each preventable adverse drug events (ADE) that took place in a hospital added about $8,750 (in 2006 dollars) to the cost of the hospital stay. Assuming 400,000 of these events each year - a conservative estimate - the total annual cost would be $3.5 billion in this one group. Another study looked at preventable ADEs in Medicare enrollees aged 65 and older and found an annual cost of $887 million for treating medication errors in this group. Unfortunately, these studies cover only some of the medication errors that occur each year in this country, and they look at only some of their costs-they do not take into account lost earnings, for example, or any compensation for pain and suffering.7

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Section III. Medication Errors

Medication Error Reporting

Medication errors are any preventable event that may cause or lead to inappropriate medication use or patient harm, while the medication is in the control of the healthcare professional, patient, or consumer. The National Coordinating Council for Medication Error Reporting and Prevention defines a medication error as "any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use."8

Most of the time medications are beneficial, or at least they cause no harm, but on occasion they do injure the person taking them. Some of these "adverse drug events [ADEs]," as injuries due to medication are generally called, are inevitable-the more powerful a drug is, the more likely it is to have harmful side effects, for instance-but sometimes the harm is caused by an error in prescribing or taking the medication, and these damages are not inevitable. They can be prevented.

Report on Preventing Medication Errors

Against this background, the Centers for Medicare and Medicaid Services requested that the Institute of Medicine study the prevalence of such medication errors and formulate a national agenda for reducing these errors. The resulting report, Preventing Medication Errors, finds that medication errors are surprisingly common and costly to the nation, and it outlines a comprehensive approach to decreasing the prevalence of these errors. This approach will require changes from doctors, nurses, pharmacists, and others in the health care industry, from the Food and Drug Administration (FDA) and other government agencies, from hospitals and other health-care organizations, and from patients.9

Hospital employees recognize and report only one out of seven errors, accidents and other events that harm Medicare patients while they are hospitalized, federal investigators say in a new report. Yet even after hospitals investigate preventable injuries and infections that have been reported, they rarely change their practices to prevent repetition of the "adverse events," according to the 2012 study released by Daniel R. Levinson, inspector general of the Department of Health and Human Services.10

Mr. Levinson notes that as a condition of being paid under Medicare, hospitals are to "track medical errors and adverse patient events, analyze their causes" and improve care. Nearly all hospitals have some type of system for employees to inform hospital managers of adverse events, defined as significant harm experienced by patients as a result of medical care.

"Despite the existence of incident reporting systems," Mr. Levinson said, "hospital staff did not report most events that harmed Medicare beneficiaries." Indeed, he said, some of the most serious problems, including some that caused patients to die, were not reported.

Adverse events include medication errors, severe bedsores, infections that patients acquire in hospitals, delirium resulting from overuse of painkillers and excessive bleeding linked to improper use of blood thinners. Federal investigators identified many unreported events by having independent doctors review patients' records. The inspector general estimated that more than 130,000 Medicare beneficiaries experienced one or more adverse events in hospitals in a single month.

The American Hospital Association lists the following as some common types of medication errors:

  • Incomplete patient information (not knowing about patients' allergies, other medicines they are taking, previous diagnoses, and lab results, for example);
  • Unavailable drug information (such as lack of up-to-date warnings);
  • Miscommunication of drug orders, which can involve poor handwriting, confusion between drugs with similar names, misuse of zeroes and decimal points, confusion of metric and other dosing units, and inappropriate abbreviations;
  • Lack of appropriate labeling as a drug is prepared and repackaged into smaller units; and
  • Environmental factors, such as lighting, heat, noise, and interruptions that can distract health professionals from their medical tasks.

Many hospital administrators acknowledged that their employees were underreporting injuries and infections that occurred in the hospital, he said. When the National Academy of Sciences issued a landmark report on patient safety in 1999, many experts said that hospital employees were often afraid to admit mistakes. But that no longer appears to be the main obstacle to reporting, federal investigators said.

More often, Mr. Levinson said, the problem is that hospital employees do not recognize "what constitutes patient harm" or do not realize that particular events harmed patients and should be reported. In some cases, he said, employees assumed someone else would report the episode, or they thought it was so common that it did not need to be reported, or "suspected that the events were isolated incidents unlikely to recur."

To clear up confusion, Medicare officials said they would develop a list of "reportable events" that hospitals and their employees could use. In addition, the Medicare agency said, hospitals should give employees "detailed, unambiguous instructions on the types of events that should be reported." The administration and hospital industry leaders have placed a high priority on reducing medical errors. But, the report said, at many hospitals, this high-level commitment has not been translated into practice.

The inspector general found that "hospitals made few changes to policies or practices" after employees reported harm to patients. In many cases, hospital executives told federal investigators that the events did not reveal any "systemic quality problems." Organizations that inspect and accredit hospitals generally "do not scrutinize" how hospitals keep track of medical errors and other adverse events, the study said.

The federal investigators did an in-depth review of 293 cases in which patients had been harmed. Forty of those cases were reported to hospital managers, and 28 were investigated by the hospitals, but only five led to changes in policies or practices, the study said. More than 2,900 hospitals have joined the administration in a "partnership for patients" intended to reduce errors and save 60,000 lives in three years.

At least 27 states have laws that require hospitals to report publicly on infections that patients develop in the hospital, according to the National Conference of State Legislatures, up from 6 at the end of 2005. In view of the state laws, administration officials said they were not proposing new federal requirements for the public reporting of adverse events.

Challenges to Preventing Medication Errors

There are numerous challenges to preventing medication errors. It is common practice, depending on the healthcare setting, to have many individuals involved in the prescribing, dispensing and administration of a medication (e.g., physicians, nurses, pharmacists, and the patient) with the potential for an error to occur at any step in the process. Healthcare professionals should be aware of the sources and types of medication errors so that they may better identify and avoid potential problems before they occur.

There are many steps that healthcare professionals can take to reduce the occurrence of medication errors at the point of prescribing a medication. Two major sources of errors in prescribing are poor penmanship and the use of error-prone abbreviations. For instance, healthcare professionals should be cognizant of their penmanship and use computerized prescriber order entry if available, to lessen any confusion that may result from poorly written prescriptions.

The following illustration is an example of a hand-written prescription for Metadate ER 10 mg tablets. Metadate is a drug used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Due to the similarity in name, poor penmanship and the omission of the modifier "ER", the pharmacy filling the prescription incorrectly dispensed methadone 10 mg tablets. Methadone is a morphine-based product used as a heroin substitution therapy and analgesic. Methadone is not used for the treatment of ADHD.

As noted above, another way healthcare professionals can minimize the confusion over handwritten prescriptions, and/or potential errors that may result in a drug's misuse is through the use of technology. For example, CPOE technology is an electronic data entry system that allows healthcare professionals to communicate instructions about a patient at either the point-of-care or remotely. Although not every institution uses CPOE, data have shown that CPOE simplifies and streamlines a patient's care, and significantly reduces medication errors. Estimates of the proportion of hospital that have fully implemented CPOE systems range from 37% to 50%. CPOE is capable of storing medical histories and can alert healthcare professionals to, among other things, drug allergies, and dangerous drug-drug or drug-device interactions.

There are certain error-prone abbreviations, symbols and dose designations that healthcare professionals should avoid. For example, the abbreviation for microgram, "?g", is often misread for milligram, "mg", when written. FDA and ISMP recommend that the abbreviation "mcg" be used in lieu of "?g". Another common source of misinterpretation and error is the use of the decimal point and a trailing zero. Writing "1.0 mg" can be read as "10 mg" if the decimal point is not clearly visible. Similarly, ".1" mg can be misinterpreted as "1 mg". FDA and ISMP recommend that no trailing zeros be used when denoting doses expressed as whole numbers and that preceding zeros be used whenever a decimal point is needed for a dose that must be administered as a fraction of a whole number. Certain abbreviations can also be misread, for example "HCL", hydrochloride, and "KCL", potassium chloride. FDA and ISMP recommend that the complete drug name be used unless expressed as a salt of the drug. By avoiding the use of abbreviations, symbols and dose designations that are easily confused with each other, the risk of error can be greatly reduced.

Another important way to avoid prescribing errors is for healthcare professionals to be up-to-date on the latest information for a product, especially for a drug that may not be commonly used. The professional product label is the best source for information on indications, proper use, and adverse events associated with a drug. The product label is updated as new information becomes available. The label provides important information that healthcare professionals should know prior to prescribing a drug. For instance, a boxed warning, when used, often contains information about serious adverse reactions (e.g., life-threatening) that should be considered when weighing the benefits of prescribing a drug. Special restrictions and distribution programs are also highlighted in boxed warnings.

Starting in 2006, the professional product label had a new look. Included at the top of the label is a highlights section. This feature makes key prescribing information about the drug readily accessible and provides an index to the rest of the information in the label. Healthcare professionals should always consult the drug label prior to prescribing a drug they are unfamiliar with or when there has been an update to the prescribing information.

Unreported Medication Errors

A wide chasm exists between the number of medication errors that occur and the number of medication errors that are reported. A significant number of medication errors, and certainly those that reach the patient, are reported; however, less severe errors and near misses-now referred to as "good catches"-often go unreported. A recent study stated that hospital employees recognize and report only one out of seven adverse events, including medication errors.

Federal investigators performed an in-depth review of 293 cases that involved patient harm: 40 cases were reported to hospital managers and 28 were investigated by the facility, but only five cases led to changes in hospital policies and procedures. Reporting of errors needs to occur far more consistently and these reports need to be investigated on a broader scale and more thoroughly. As we know, incidents that appear to be isolated events are often indicative of larger, systemic problems in the medication use process. Robust investigation of medication errors should drive changes in policies and procedures, if indicated by the evidence found during analyses.

Practicing a non-punitive approach and assuring staff that error reporting is both welcomed and expected should be a priority for all administrators and pharmacy leaders if the rates of error reporting are to improve. For a culture of safety to fully permeate an organization, the impetus must come from the top management and filter down through every level in the hospital. Guiding hospital leaders toward a culture of safety is particularly important if they do not have a clinical background and are not experienced in analyzing an error as a clinician. When hospital leaders routinely walk through the patient care units, speak to the staff, and ask about safety, it sends a clear message to employees that the leaders truly care about patient safety. Involving the leaders in part of the error analysis-both prospectively and retrospectively-also helps them understand the complexity of the medication use system.11

In addition, staff members may falsely assume that the error made is so common that it does not need to be reported, or, conversely, that the mistake is an aberration, ie, that no one else could possibly repeat the error. Ongoing education of staff on the importance of promptly reporting all medication errors-even those that seem unimportant or that they believe to be a one-time mistake-is critical in improving reporting rates.

Underreporting of errors also occurs because staff members had reported errors previously, but did not receive a response or witness any action taken as a result of the disclosure. When a staff member takes the time to follow through with an error report, pharmacy leadership and administration must treat this report seriously and respond, even when it is decided that no comprehensive change in policy or procedure is required. Witnessing tangible changes that result from error reporting induces the reporting employee, as well as his or her coworkers, to believe in the reporting process as a means for improving patient safety.

Reporting Medication Errors

Near misses, or good catches, are particularly useful to share with staff as a way to recognize employees for their good work, rather than only acknowledging errors. Share this information, along with actual errors, during regularly scheduled staff meetings. If privacy is a concern, consider sharing the event but keeping the staff member anonymous. Many facilities have pharmacy-nurse committee meetings, which present ideal, ongoing opportunities to share information relevant to both departments in an effort to improve practice and patient safety. Oftentimes, errors have only been reported to the safety committee, so make it typical practice to discuss errors and near misses on a regular basis to familiarize staff with the process. Sharing successes as well as errors illustrates to staff that their contributions are valued, encourages continued reporting, and improves the hospital culture of safety.

Experience has shown that for a reporting system to be effective, it must be simple, easy to use, and not time consuming. If a staff member is required to fill out a long, complicated form each time they want to report an error, it is unlikely many errors will be reported.

In previous years, lack of education on what defined a reportable error may have been an issue. However, reporting guidelines have existed long enough that now most staff members are aware of what constitutes a reportable error. The National Quality Forum (NQF) developed a list of serious reportable events in 2002, and updated it in June 2011. The NFQ updated list specifies that patient death or serious injury associated with the use of contaminated drugs or with a medication error (wrong drug, wrong dose, wrong patient, wrong time, wrong preparation, wrong route of administration) are considered serious reportable care management events.

The problem lies in incentivizing staff to follow through with error reporting. While additional education is always beneficial, we need to focus especially on diminishing the culture of blame and encouraging a culture of safety so more errors are reported. Having a broad understanding of what errors are occurring day-to-day is vital to uncovering and implementing practical solutions.

The best system is the one that works effectively for that facility. Because hospitals have different levels of automation, what works well for one facility may not work well for another. Some facilities have medication error hotlines, where staff call in and report errors.

Pharmacies serve an important role as part of the hospital's medication safety net. Pharmacies and state boards of pharmacy also have developed strategies to reduce medication errors. Some state boards have established hotlines for patients to call to report a medication error. They require posting of signs in pharmacies notifying patients of these phone numbers.

Product Labeling and Packaging

Medication errors may be related to professional practice, the product itself, and/or the procedures and systems related to distribution, dispensing and administration of drugs. For instance, drugs may be given names, shapes, or colors similar to other medications. As illustrated below, similarities in product packaging may result in confusion among healthcare professionals charged with dispensing drugs or among patients taking drugs at home.12

The following illustration is an example of similar looking packaging from the same manufacturer for two unrelated drugs. On the left are 50 mg tablets of hydroxyzine HCL, a sedating antihistamine. On the right are 50 mg tablets of hydralazine HCL, an antihypertensive drug. The packaging of these products may lead to a serious medication error.

Although medication errors can and do occur it is difficult to assess how frequently such errors occur in medical and pharmacy practice. Medication errors such as those involving the wrong drug, an extra or wrong dose, omission of a drug, administering a drug by the wrong route or at an incorrect time are commonly reported to the FDA. Many of these errors can be prevented simply by communicating more effectively.

However, some types of errors may require additional interventions such as a change in the product name, labeling and/or packaging to help minimize the likelihood of further confusion. Continued training and vigilance is essential in helping healthcare professionals and FDA reduce the likelihood of an error being made. Reporting medication errors to FDA via MedWatch, or to FDA's partners in this effort, the Institute for Safe Medical Practices (ISMP) and the U.S. Pharmacopeia via their MedMarx program, helps FDA identify factors leading to errors that can be corrected, lessening the likelihood of their recurrence.

Hospital Strategies

Hospitals and other health care organizations work to reduce medication errors by using technology, improving processes, zeroing in on errors that cause harm, and building a culture of safety. When health care providers have access to complete and accurate information, patients receive better medical care.

Health Information Technology

Expectations remain high that health information technology, particularly electronic medical records (EMRs), will improve clinical outcomes while reducing health care costs. One of the most costly aspects of medical care is patient safety events. A new study by William E. Encinosa, Ph.D., from the Agency for Healthcare Research and Quality (AHRQ), and Jaeyong Bae, M.A., from Emory University found that EMRs do not reduce the rate of these events. However, after they occur, EMRs do reduce the negative outcomes and related costs that can occur.

The two researchers obtained patient outcome data on 35 million enrollees in employer-sponsored benefit plans for large employers in all 50 States. This included information on claims for inpatient and outpatient care and prescription drugs. They also used an information technology database to obtain EMR data on 92,853 non-elderly adults undergoing major surgeries at 2,619 hospitals. Annual hospital survey data were used to determine hospital characteristics. Nearly 21 percent of surgeries were performed in hospitals with basic EMRs.

Overall, 5 percent of the surgeries resulted in at least 1 of 24 potentially preventable adverse medical events. No differences in the rates of patient safety events were observed between EMR and non-EMR hospitals. However, EMR hospitals spent less on a patient safety event ($55,810) than non-EMR hospitals ($60,093). Also, in EMR hospitals, deaths after patient safety events were reduced by 34 percent and hospital readmissions by 39 percent. Additional research is needed to determine why EMRs do not prevent patient safety events, but do reduce negative outcomes once they occur.

Computerized Physician Order Entry (CPOE)

Studies have shown that Computerized Physician Order Entry (CPOE) is effective in reducing medication errors. It involves entering medication orders directly into a computer system rather than on paper or verbally. The Institute for Safe Medication Practices conducted a survey of 1,500 hospitals in 2001 and found that about 3 percent of hospitals were using CPOE, and the number is rising. Eugene Wiener, M.D., medical director at the Children's Hospital of Pittsburgh, says, "There is no misinterpretation of handwriting, decimal points, or abbreviations. This puts everything in a digital world."

The Pittsburgh hospital unveiled its CPOE system in October 2002. Developed by the hospital and the Cerner Corp. in Kansas City, Mo., Children'sNet has replaced most paper forms and prescription pads. Wiener says that, unlike with adults, most drug orders for children are generally based on weight. "The computer won't let you put an order in if the child's weight isn't in the system," he says, "and if the weight changes, the computer notices." The system also provides all kinds of information about potential drug complications that the doctor might not have thought about. "Doctors always have a choice in dealing with the alerts," Wiener says. "They can choose to move past an alert, but the alert makes them stop and think based on the specific patient indications."

Prescribing and Dispensing Medications

Another important step in reducing the number of medication errors will be to make greater use of information technologies in prescribing and dispensing medications. Doctors, nurse practitioners, and physician assistants, for example, cannot possibly keep up with all the relevant information available on all the medications they might prescribe-but with today's information technologies they don't have to. By using point-of-care reference information, typically accessed over the Internet or from personal digital assistants, prescribers can obtain detailed information about the particular drugs they prescribe and get help in deciding which medications to prescribe.

Even more promising is the use of electronic prescriptions, or e-prescriptions. By writing prescriptions electronically, doctors and other providers can avoid many of the mistakes that accompany handwritten prescriptions, as the software ensures that all the necessary information is filled out-and legible. Furthermore, by tying e-prescriptions in with the patient's medical history, it is possible to check automatically for such things as drug allergies, drug-drug interactions, and overly high doses. In addition, once an e-prescription is in the system, it will follow the patient from the hospital to the doctor's office or from the nursing home to the pharmacy, avoiding many of the "hand-off errors" common today.

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Section IV. Building a Culture of Safety

Health Care System Culture

One component of any health care "system" is its culture, defined as the shared ways of thinking, acting, and interacting among a group of individuals. Researches examining nonmedical industries such as aviation and nuclear safety have identified the value of "cultures of safety," which further enhance organizational learning capacity and reduce mistakes. The development of a learning-oriented culture in health care organizations, particularly in relation to doctors and nurses, is a key facilitator for improving the quality of care.13

Best Practices

There are several cultural "best practices" physicians can implement to increase the likelihood that medical mistakes, near misses, and lapses in patient safety will be detected in a timely manner, providing added opportunity for reflection and identification of the underlying causes. Additionally, their participation further ensures that the contributing factors will be addressed, and that the larger delivery-of-care system is reconfigured to reduce the probability of a recurrence. In theory, immersion in a learning culture turns physicians into thinkers as well as problem-solvers, and change agents rather than defenders of the status quo. Their involvement also makes the physicians more proactive clinical leaders, capable of directing other health care personnel in the adoption of a systems approach to safety.

The following chart illustrates the recommended individual and group "best practices" associated with a learning culture around mistakes.

Best practice

Definition

Individual practices:

Habit of inquiry

Willingness to engage surrounding individuals (superiors, peer colleagues, non-physician co-workers) with respect to asking questions around mistakes, patient safety, and correct ways of doing work. Tendency to ask "why" in addition to "how" around the processes for identifying, investigating, and resolving mistake and near-miss situations.


Self-reflection

Extended self-examination of near misses and mistakes, in particular around how the near miss or mistake is being conceptualized by the individual and the larger lessons to be learned from it.


Personal forgiveness

Willingness to forgive oneself for committing a near miss or mistake, not excusing one's part in the incident but not letting the event create untrue or exaggerated beliefs in the individual's mind.


Expressions of doubt and fallibility

Willingness to reveal to oneself and others concerns over "knowing all the right things" or "making a mistake."


Sharing experiences

Regularly communicating to others personal stories and experiences about near misses and mistakes committed.


Empathy toward others

Expressing feelings and concern for those in the group who make mistakes and experience failure; a "there but for the grace of God go I" mentality that allows the individual to gain understanding from someone else's experience.


Systems thinking

Thinking about or couching episodes of mistake or failure within the context of the total surrounding system of care, as well as contextual features of the individual's work life (e.g., fatigue) that may serve as contributory factors. Willingness to develop logics that link contextual factors to increased probability for the mistake or failure.


Group practices:

Feedback

Higher levels in the training hierarchy communicating down to lower levels specific aspects of why something is a mistake. Whether or not that communication is positive, negative, or valuable to lower levels, the communication provides information that allows the lower levels to understand the point of view and "norms" of higher levels.


Collaborative inquiry

Adopting a collective approach to uncovering, examining, and resolving a mistake or near-miss problem. Employing a flattened rather than purely hierarchical approach to gaining and assessing information around the problem.


Reciprocal communication

Communication moving both from top-down and bottom-up throughout the team, with less experienced members afforded equivalent chances of injecting their views, concerns, etc.


Creative tension

Disagreements in the group are tolerated, listened to, and resolved not by fiat but by trying to reach consensus, not limited to consensus of the most experienced individuals in the team. The group tolerates debate and disagreement where uncertainty is high around a mistake or near miss, using that disagreement to generate a variety of explanatory interpretations.


Real-time experimentation

Willingness for the group as a whole, spearheaded by higher levels in the training hierarchy, to recast mistake or mistake events in a way that questions the underlying assumptions upon which the work leading to that mistake or mistake is done.


Real-time briefings

Willingness of higher levels in the training hierarchy to, at the moment a mistake is discovered or heard about, take a constructive approach to educating lower levels around ways to lessen the probability for such a mistake to happen again in the future.

Patient Provider Relationship

Patients should be encouraged to take a more active role in their own medical care. In the past the nation's health care system has generally been paternalistic and provider-centric, and patients have not been expected to be involved in the process. But one of the most effective ways to reduce medication errors, the report concludes, is to move toward a model of health care where there is more of a partnership between the patients and the health care providers. Patients should understand more about their medications and take more responsibility for monitoring those medications, while providers should take steps to educate, consult with, and listen to the patients.

To make this new model of health care work, a number of things must be done. Doctors, nurses, pharmacists and other providers must communicate more with patients at every step of the way and make that communication a two-way street, listening to the patients as well as talking to them. They should inform their patients fully about the risks, contraindications, and possible side effects of the medications they are taking and what to do if they experience a side effect. They should also be more forthcoming when medication errors have occurred and explain what the consequences have been.

Patients or their surrogates should in turn take a more active role in the process. They should learn to keep careful records of all the medications they are taking and take greater responsibility for monitoring those medications by, for example, double-checking prescriptions from pharmacies and reporting any unexpected changes in how they feel after starting a new medication. Also, the healthcare system needs to do a better job of educating patients and of providing ways for patients to educate themselves. Patients should be given opportunities to consult about their medications at various stages in their care-during consultation with the providers who prescribe their medications, at discharge from the hospital, at the pharmacy, and so on. And there needs to be a concerted effort to improve the quality and the accessibility of information about medications provided to consumers.

30 Safe Practices for Improving Patient Safety

The National Quality Forum-endorsed 30 Safe Practices cover a range of practices that, if utilized, should reduce the risk of harm in certain processes, systems or environments of care. Within the 30 practice areas, one practice relates to creating a culture of safety, four to matching care needs to service capability, nine to improving information transfer and communication, twelve to specific care processes, and four to events and medical errors.14

Culled from an initial set of 220 practices, the final set was endorsed following a formal Consensus Development Process undertaken by a diverse set of health care organizations, who then recommended which practices should be universally implemented.

The 30 safe practices that follow have been endorsed by the membership of the National Quality Forum, which includes representatives of 215 of the Nation's leading health care provider, purchaser, and consumer organizations.

These organizations strongly urge that these 30 safe practices be universally adopted by all applicable health care settings to reduce the risk of harm to patients.

30 Safe Practices for Improving Patient Safety15

Creating a Culture of Safety

1. Create a health care culture of safety.

There is a need to promote a culture that overtly encourages and supports the reporting of any situation or circumstance that threatens, or potentially threatens, the safety of patients or caregivers and that views the occurrence of errors and adverse events as opportunities to make the health care system better.

Matching Health Care Needs with Service Delivery Capability

2. For designated high-risk, elective surgical procedures or other specified care, patients should be clearly informed of the likely reduced risk of an adverse outcome at treatment facilities that have demonstrated superior outcomes and should be referred to such facilities in accordance with the patient's stated preference.

3. Specify an explicit protocol to be used to ensure an adequate level of nursing based on the institution's usual patient mix and the experience and training of its nursing staff.

4. All patients in general intensive care units (both adult and pediatric) should be managed by physicians having specific training and certification in critical care medicine ("critical care certified").

5. Pharmacists should actively participate in the medication-use process, including, at a minimum, being available for consultation with prescribers on medication ordering, interpretation and review of medication orders, preparation of medications, dispensing of medications, and administration and monitoring of medications.

Facilitating Information Transfer and Clear Communication

6. Verbal orders should be recorded whenever possible and immediately read back to the prescriber; that is, a health care provider receiving a verbal order should read or repeat back the information that the prescriber conveys in order to verify the accuracy of what was heard.

7. Use only standardized abbreviations and dose designations.

8. Patient care summaries or other similar records should not be prepared from memory.

9. Ensure that care information, especially changes in orders and new diagnostic information, is transmitted in a timely and clearly understandable form to all of the patient's current health care providers who need that information to provide care.

10. Ask each patient or legal surrogate to recount what he or she has been told during the informed consent discussion.

11. Ensure that written documentation of the patient's preference for life-sustaining treatments is prominently displayed in his or her chart.

12. Implement a computerized prescriber-order entry system.

13. Implement a standardized protocol to prevent the mislabeling of radiographs.

14. Implement standardized protocols to prevent the occurrence of wrong-site or wrong-patient procedures.

In Specific Settings or Processes of Care

15. Evaluate each patient undergoing elective surgery for risk of an acute ischemic cardiac event during surgery, and provide prophylactic treatment for high-risk patients with beta blockers.

16. Evaluate each patient upon admission, and regularly thereafter, for the risk of developing pressure ulcers. This evaluation should be repeated at regular intervals during care. Clinically appropriate preventive methods should be implemented consequent to the evaluation.

17. Evaluate each patient upon admission, and regularly thereafter, for the risk of developing deep vein thrombosis/venous thromboembolism. Utilize clinically appropriate methods to prevent both.

18. Utilize dedicated anti-thrombotic (anti-coagulation) services that facilitate coordinated care management.

19. Upon admission, and regularly thereafter, evaluate each patient for the risk of aspiration.

20. Adhere to effective methods of preventing central venous catheter-associated bloodstream infections.

21. Evaluate each pre-operative patient in light of his or her planned surgical procedure for the risk of surgical site infection, and implement appropriate antibiotic prophylaxis and other preventive measures based on that evaluation.

22. Utilize validated protocols to evaluate patients who are at risk for contrast media-induced renal failure, and utilize a clinically appropriate method for reducing risk of renal injury based on the patient's kidney function evaluation.

23. Evaluate each patient upon admission, and regularly thereafter, for risk of malnutrition. Employ clinically appropriate strategies to prevent malnutrition.

24. Whenever a pneumatic tourniquet is used, evaluate the patient for the risk of an ischemic and/or thrombotic complication, and utilize appropriate prophylactic measures.

25. Decontaminate hands with either a hygienic hand rub or by washing with a disinfectant soap prior to, and after, direct contact with the patient or objects immediately around the patient.

26. Vaccinate health care workers against influenza to protect both them and patients.

Increasing Safe Medication Use

27. Keep workspaces where medications are prepared clean, orderly, well lit, and free of clutter, distraction, and noise.

28. Standardize the methods for labeling, packaging, and storing medications.

29. Identify all "high alert" drugs (for example, intravenous adrenergic agonists and antagonists, chemotherapy agents, anticoagulants and anti-thrombotics, concentrated parenteral electrolytes, general anesthetics, neuromuscular blockers, insulin and oral hypoglycemics, narcotics, and opiates).

30. Dispense medications in unit-dose or, when appropriate, unit-of-use form, whenever possible.

Seven Pillars Process

One example of a Culture of Safety is the "Seven Pillars" process which was adopted by the Chicago hospital system in 2006. The process is based on openness about medical errors or near-misses so health care providers can fix and prevent them. Today, it is getting attention from hospitals in other States.16

"Seven Pillars" consists of these steps:

  1. Report incidents that could harm patients.
  2. Investigate those cases and fix problems before an error happens.
  3. Communicate when an error occurs, even if no harm was done.
  4. Apologize and "make it right" by waiving hospital and doctors' fees.
  5. Fix gaps in the system that can cause things to go wrong.
  6. Track data from patient safety reports and see if changes make things safer.
  7. Educate and train staff how to make care safer.

Early indicators are that the results of this process are positive. Hospital staff are reporting patient safety incidents, and talking to patients when near-misses or errors take place. In cases where inappropriate care has taken place, patients aren't stuck paying fees.

Only 2 years after it started, the process led to more than 100 investigations and nearly 200 specific improvements. It was also the basis for 20 full disclosures of inappropriate care that caused patient harm.

The Seven Pillars process works because it spells out and follows steps that we know make a lasting difference in building a safer health system. Reporting, communicating, creating a culture of learning, and other improvements move us closer to identifying and fixing patient safety gaps, rather than simply assigning blame.

There's proof from Michigan that zero harm may be an attainable goal. In just 18 months, a partnership between the Michigan Health and Hospital Association and Johns Hopkins University, known as the Keystone Project, reduced the rate of bloodstream infections by two thirds among patients in intensive care units receiving central lines, the catheters that carry medicines and nutrients directly into blood vessels. That translates into more than 1,500 lives, and at least $100 million, saved each year. About one quarter of the ICUs have eliminated the infections altogether. At Keystone's core is a checklist-from hand-washing to wearing masks, gowns, and gloves-that medical teams must follow. Team members tick off each item on the list to make sure that each procedure is carried out in the proper order and nothing is missed. They also relentlessly monitor infection rates, working collaboratively to identify sources of infection and wipe them out. Peter Pronovost, a Johns Hopkins anesthesiologist and critical care specialist who launched the program, says he's now received government funding to extend the program to more than 1,400 ICUs in 48 states.17

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Section V. Academy of Nutrition and Dietetics (AND) Medical Nutrition Therapy Documentation

Defining the Role of the Registered Dietitian and Medical Nutrition Therapy

The registered dietitian is the health care provider with the most intensive experience necessary to provide nutrition services to individuals interested in medical nutrition therapy or preventive nutrition counseling.

Medical nutrition therapy (MNT) is defined as a plan or set of steps, developed through a consultative process by a Registered Dietitian, which incorporates current professional knowledge and research, and clearly defines the level, content, and frequency of nutrition care that is appropriate for a disease or condition. Medical nutrition therapy begins with the nutritional assessment of a client, followed by a medically prescribed nutrition therapy based on standard protocols.

Medical nutrition therapy includes identifying treatment goals and developing the nutrition prescription, providing self-management training through individualized counseling and designing specialized nutrition therapies. During MNT, the registered dietitian provides clients with a comprehensive service that includes an assessment of the nutrition status of a client with a disease, condition, illness or injury that puts the patient at nutritional risk. This nutrition assessment consists of a review and analysis of medical and dietary history, laboratory test values, anthropometric measurements, and food/prescription drug interactions.

Academy of Nutrition and Dietetics Documentation

In Academy of Nutrition and Dietetics's (AND) notes in their Medical Nutrition Therapy Documentation recommendations that communication among team members is important to provide consistent, quality care. Documentation is one form of communication and is a necessary part of medical care. Documentation is also essential for verifying the quality of care delivered and determining outcomes of care. One of the recommended activities is to document the circumstances and handling of errors.15

The medical record is a legal document that is maintained for communication of care, and includes a description of the care provided and delineation of who provided the care to the client. The government, private insurance companies and healthcare accrediting agencies mandate that the medical record be complete, accurate, and retained for a number of years as stipulated by Medicare or state laws. Reimbursement is also dependent on documentation.

Evidence Based Guides for Practice

The RD will find that the Academy of Nutrition and Dietetics MNT Evidence Based Guides for Practice (protocols and practice guidelines) provide resources for supporting that the RD meet the following documentation essentials. The dietitian documents the following in the patient's medical record:

Initial MNT:

  • Receipt of referral, and name of primary dietitian
  • Diagnosis
  • Time and date of the visit.
  • Demographic data, measurements
  • Nutrition Assessments -- Nutrition history
  • Baseline data intake
  • Learning needs assessment r/t MNT
  • Clinical and behavioral goals -- Care Plan
  • Interventions -- MNT provided
  • Adherence potential
  • Scheduling of follow-up appointment

Follow-up MNT Sessions:

  • Time and date of the visit.
  • Lab data and measurements
  • Progress to goals
  • Adjustments to CarePlan
  • Interventions -- New and reinforcement
  • Barriers and solutions
  • Next Follow-up appointment
  • Appointment failures, and other ways that the patient is not cooperating with the therapeutic plan
  • Follow-up plans

Dos and Don'ts of Documentation

Here are some tips recommended by the Academy of Nutrition and Dietetics to help improve the RD's charting:

Do:

  • Check that you have the correct chart before you write.
  • Chart a patient's refusal to allow treatment. Be sure to report this to the patient's physician.
  • Write "late entry" and the date and time if you forgot to document something.
  • Write often enough to tell the whole story.
  • Chart preventive measures.
  • Chart contemporaneously (contemporaneous notes are credible).
  • Write legibly, offering concise, clear notes reflecting facts.
  • Chart what you report to other healthcare providers.
  • Chart solutions as well as problems.
  • Document your observations. Write only what you see, hear, feel, or smell.
  • Encourage others to document relevant information that they share with you.
  • Document circumstances and handling of errors.
  • Chart your efforts to answer your patients' questions.
  • Chart patient/family teaching and response.
  • Chart all referrals/support efforts.

Don't:

  • Chart a verbal order unless you have received one.
  • Chart a symptom (for instance: c/o excessive thirst), without also charting what you did about it.
  • Wait until the end of the day and rely on memory.
  • Ever alter a record. If you make an error, do mark through it with one line, indicate you are making a correction, and initial (or sign) and date.
  • Document what someone else said they heard, saw, or felt (unless the information is critical -- then quote and attribute).
  • Write trivia: "a good day." (What does that mean?)
  • Be imprecise. Avoid terms like "large amounts" and "appears."
  • Write your opinions.
  • Blanket chart or pre-chart. It is considered fraud to chart that you've done something you didn't do.

It is the position of The Academy of Nutrition and Dietetics that medical nutrition therapy is effective in treating disease and preventing disease complications, resulting in health benefits and cost savings for the public. Therefore, medical nutrition therapy provided by dietetics professionals is an essential reimbursable component of comprehensive health care services.

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Section VI. Health Care Organization Accrediting Requirements

Joint Commission on Accreditation of Health Care Organizations

The Joint Commission evaluates and accredits nearly 15,000 health care organizations and programs in the United States. An independent, not-for-profit organization, the Joint Commission is the nation's predominant standards-setting and accrediting body in health care. Since 1951, the Joint Commission has maintained state-of-the-art standards that focus on improving the quality and safety of care provided by health care organizations.

The Joint Commission's comprehensive accreditation process evaluates an organization's compliance with these standards and other accreditation requirements. Joint Commission accreditation is recognized nationwide as a symbol of quality that reflects an organization's commitment to meeting certain performance standards. To earn and maintain the Joint Commission's Gold Seal of Approval™, an organization must undergo an on-site survey by a Joint Commission survey team at least every three years.

Joint Commission's Mission Statement is to continuously improve the safety and quality of care provided to the public through the provision of health care accreditation and related services that support performance improvement in health care organizations.

Joint Commission standards address the organization's level of performance in key functional areas, such as patient rights, patient treatment, and infection control. The standards focus not simply on an organization's ability to provide safe, high quality care, but on its actual performance as well. Standards set forth performance expectations for activities that affect the safety and quality of patient care. If an organization does the right things and does them well, there is a strong likelihood that its patients will experience good outcomes. The Joint Commission develops its standards in consultation with health care experts, providers, measurement experts, purchasers, and consumers.

Sentinel Event Statistics - June 2012

A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase, "or the risk thereof" includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. Such events are called "sentinel" because they signal the need for immediate investigation and response.

This sentinel event-related data, reported to The Joint Commission from their accredited organizations, demonstrates the need of the Joint Commission and accredited health care organizations to continue to address these serious adverse events. This data also supports the importance of establishing National Patient Safety Goals and focusing our energies on addressing serious errors within health care organizations. By identifying causes, trends, settings and outcomes of sentinel events, The Joint Commission can provide critical information in the prevention of sentinel events to accredited health care organizations and the public.18

This data includes:

  • Type of Sentinel Event
  • Settings of Sentinel Events
  • Sources for SE Identification
  • Sentinel Event Outcomes
  • Self-reported Sentinel Events by Year
  • Method for Review of HCO Response to Sentinel Event

The reporting of most sentinel events to The Joint Commission is voluntary and represents only a small proportion of actual events.19

The majority of sentinel events occur in hospitals. There were a total of 4,234 general hospital sentinel events reported as of June 30, 2012. The following chart shows the number and percentage of the total sentinel events listed by type of facility.

Hospitals account for 64.6% of all sentinel events.20

The some of the most frequently reported sentinel even category are listed in the following type of sentinel event are wrong site surgery, patient suicide and delay in treatment.

National Patient Safety Goals

The purpose of the Joint Commission's National Patient Safety Goals is to promote specific improvements in patient safety. The goals highlight problematic areas in health care and describe evidence and expert-based consensus to solutions to these problems. Recognizing that sound system design is intrinsic to the delivery of safe, high quality health care, the goals generally focus on system-wide solutions.

No adverse event should ever occur anywhere in the world if the knowledge exists to prevent it from happening. However, such knowledge is of little use if it is not put into practice. Translating knowledge into practical solutions is the ultimate foundation of the safety solutions.

The basic purpose of the solutions is to guide the re-design of care processes to prevent inevitable human errors from actually reaching patients. An individual solution will present the problem, the strength of evidence supporting the solution, potential barriers to adoption, risks of unintended consequences created by the solution, patient and family roles in the solution, and references and other resources.

Patient Safety Solutions are defined as: "Any system design or intervention that has demonstrated the ability to prevent or mitigate patient harm stemming from the processes of health care."

Nine Patient Safety Solutions

The International Steering Committee of the Joint Commission has approved nine solutions for dissemination. The nine inaugural patient safety solutions are:21

1. Look-Alike, Sound-Alike Medication Names

Confusing drug names is one of the most common causes of medication errors and is a worldwide concern. With tens of thousands of drugs currently on the market, the potential for error created by confusing brand or generic drug names and packaging is significant.

2. Patient Identification

The widespread and continuing failures to correctly identify patients often leads to medication, transfusion and testing errors; wrong person procedures; and the discharge of infants to the wrong families.

3. Communication During Patient Hand Overs

Gaps in hand-over (or hand-off) communication between patient care units, and between and among care teams, can cause serious breakdowns in the continuity of care, inappropriate treatment, and potential harm for the patient.

4. Performance of Correct Procedure at Correct Body Site

Considered totally preventable, cases of wrong procedure or wrong site surgery are largely the result of miscommunication and unavailable, or incorrect, information. A major contributing factor to these types of errors is the lack of a standardized preoperative process.

5. Control of Concentrated Electrolyte Solutions

While all drugs, biologics, vaccines and contrast media have a defined risk profile, concentrated electrolyte solutions that are used for injection are especially dangerous.

6. Assuring Medication Accuracy at Transitions in Care

Medication errors occur most commonly at transitions. Medication reconciliation is a process designed to prevent medication errors at patient transition points.

7. Avoiding Catheter and Tubing Mis-Connections

The design of tubing, catheters, and syringes currently in use is such that it is possible to inadvertently cause patient harm through connecting the wrong syringes and tubing and then delivering medication or fluids through an unintended wrong route.

8. Single Use of Injection Devices

One of the biggest global concerns is the spread of Human Immunodeficiency Virus (HIV), the Hepatitis B Virus (HBV), and the Hepatitis C Virus (HCV) because of the reuse of injection needles.

9. Improved Hand Hygiene to Prevent Health Care-Associated Infection

It is estimated that at any point in time more than 1.4 million people worldwide are suffering from infections acquired in hospitals. Effective hand hygiene is the primary preventive measure for avoiding this problem.

The Official "Do Not Use" List of Abbreviations

In May 2005, The Joint Commission affirmed its "do not use" list of abbreviations. The list was originally created in 2004 by The Joint Commission as part of the requirements for meeting National Patient Safety Goal Requirement 2B (Standardize a list of abbreviations, acronyms and symbols that are not to be used throughout the organization).

While no additions will be made to the "do not use" list at this time, the following items will be reviewed annually for possible inclusion as part of the development of future Joint Commission NPSGs:

An example of the recommended "Do Not Use" List is as follows:


For accreditation purposes, the official "do not use" list applies, at a minimum, to all orders and all medication-related documentation that is handwritten (including free-text computer entry) or on pre-printed forms. This requirement does not currently apply to preprogrammed health information technology systems (for example, electronic medical records or CPOE systems), but remains under consideration for the future. Organizations contemplating introduction or upgrade of such systems should strive to eliminate the use of dangerous abbreviations, acronyms, symbols, and dose designations from the software.

Joint Commission's Future Measurement Objectives

The Joint Commission's future measurement objectives must allow continuing adaptation to the rapidly changing health care environment and pursuit of the on-going elaboration of performance measurement as a national collaborative activity. To facilitate achievement of these objectives, the Joint Commission's Performance Measurement Strategic Issues Work Group has developed a set of principles to guide this work. Over the next five years, efforts will focus on:22

  • Refinement of the process for electronic receipt of high quality standardized performance measure data that cover all aspects of care delivery within and across the various types of health care organizations (e.g., hospitals, long term care, home care, etc.). Approaches to refining this process will include exploration of the potential to expand the capability of the electronic health record to capture measure data as a byproduct of the health care delivery process.
  • Expansion of the scope of measure sets available for selection by health care organizations. This includes increasing the complement of measure sets for hospitals to provide a broader menu for measure selection as well as implementing standardized measurement strategies for other accreditation programs including long term care, home care, behavioral health care, and ambulatory care.
  • Creation of sophisticated applications of measurement data use for accreditation, accountability and public reporting purposes.
  • Coordination of data demands and prioritization of critical measurement areas by the various public and private sector entities to minimize data collection burden and eliminate redundancies for health care organizations, while maximizing the consistency and usefulness of the data.

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Section VII. State Legal Reporting Requirements

State Reporting Requirements

Each state has their own legal requirements for the reporting of medical errors. The "Yale Journal of Health Policy, Law, and Ethics" can serve as a starting point in reviewing the laws in your state.

  • "Yale Journal of Health Policy, Law, and Ethics" - A National Survey of Medical Error Reporting Laws. http://www.yale.edu/yjhple/issues/vix-i1-win09/docs/feature.pdf

State of Florida Requirements

As an example of the scope of reporting requirements this section will review the laws for the State of Florida.23

1. GENERAL DESCRIPTION: Licensed health care facilities are required to establish internal risk management programs that include an investigation of the frequency and causes of specific types of adverse incidents. Certain adverse incidents must then be reported to the Agency for Health Care Administration and the Department of Health.

2. IS REPORTING MANDATORY? Yes.

3. REPORT RECIPIENT(S): The Agency for Health Care Administration and the Department of Health. The Florida Patient Safety Corporation, a nonprofit entity, then reviews these adverse event reports in order to recommend "changes in practices and procedures . . . to improve health care quality and to prevent future adverse incidents."

4. IS REPORTING CONDUCTED ELECTRONICALLY? Unclear from statutes and regulations.

5. WHAT FACILITIES MUST PROVIDE REPORTS? All licensed facilities must provide reports. These facilities include the office practices of medical doctors and osteopathic practitioners.

6.WHAT INCIDENTS MUST BE REPORTED? "Adverse incidents" must be reported. The Florida statute defines an "adverse incident" as "an event over which health care personnel could exercise control and which is associated in whole or in part with medical intervention, rather than the condition for which such intervention occurred," and which falls into one of four categories. The first are incidents that result in one of the following injuries:

(1) Death
(2) Brain or spinal damage
(3) Permanent disfigurement
(4) Fracture or dislocation of bones or joints
(5) A resulting limitation of neurological, physical, or sensory function which continues after discharge from the facility
(6) Any condition that required specialized medical attention or surgical intervention resulting from nonemergency medical intervention, other than an emergency medical condition, to which the patient has not given his or her informed consent
(7) Any condition that required the transfer of the patient, within or outside the facility, to a unit providing a more acute level of care due to the adverse incident, rather than the patient's condition prior to the adverse incident.

The second category of incidents includes "the performance of a surgical procedure on the wrong patient, a wrong surgical procedure, a wrong-site surgical procedure, or a surgical procedure otherwise unrelated to the patient's diagnosis or medical condition."

The third category of incidents "require[s] the surgical repair of damage resulting to a patient from a planned surgical procedure, where the damage was not a recognized specific risk, as disclosed to the patient and documented through the informed-consent process."

The fourth type of adverse incidents results from "a procedure to remove unplanned foreign objects remaining from a surgical procedure."Internal risk managers at licensed facilities must also investigate allegations of sexual misconduct.

7. MUST HOSPITAL-ACQUIRED INFECTIONS BE REPORTED? No.

8. DEADLINES: Facilities have three business days to report adverse incidents to their own internal risk management programs. Certain adverse events must then be reported to the Department of Health within fifteen days.

9. PENALTIES AND ENFORCEMENT MECHANISMS: For non-willful violations of the reporting requirements, the Agency for Health Care Administration first seeks corrective action by the facility. If the facility fails to demonstrate this correction within the timeframe established by the Agency, or if the Agency discovers a pattern of non-willful violations, the Agency may impose administrative fines, not to exceed $5000 for any individual violation. Penalties for repeated non-willful violations may not exceed $10,000 per violation. Penalties for intentional and willful violations may not exceed $25,000 per violation, per day, and may not exceed $250,000 total.

(a) Revocation of license? Unclear from statutes and regulations.
(b) Audits? As part of its licensure process, the Agency for Health Care Administration is directed to review the internal risk management program at each licensed facility to determine whether the program is appropriately reporting adverse incidents.

10. ARE PUBLIC REPORTS ISSUED? Each licensed facility must submit an annual report summarizing its adverse incident reports for the prior year. This annual report is confidential and is not available to the public. However, on at least a quarterly basis, the Agency for Health Care Administration must publish "a summary and trend analysis of adverse incident reports . . . ." These reports shall not include information that would identify the reporting facility or the practitioners involved. Victims of adverse events have the right to their records and adverse event reports.

11. ARE ERROR REPORTS PROTECTED FROM LEGAL DISCOVERY? Yes.

12. IMMUNITY FOR REPORTERS? Yes

13. ANY PAY-FOR-PERFORMANCE PROGRAMS IMPLEMENTED? No.

14. RELEVANT STATUTES AND REGULATIONS: FLA. STAT. § 381.0271 (2006); FLA. STAT. § 381.028 (2006); FLA. STAT. § 395.0197 (2006); FLA. STAT. § 458.351 (2006); FLA. STAT. § 459.026 (2006).

15. OTHER RESOURCES: N/A.

16. DATE REPORTING STARTED: Unknown.

Course Summary

There are many different types of medical errors that can occur in all different types of facilities. Reducing the number of medical errors and improving the response to errors is the number one goal. Much work remains to be done and there is still much to be learned but the important issue is that systems, process improvements and recommendations are now being set into place. All that was discussed in this course proves a call to action to make health care safer for patients. A major force for the improvement of patient safety is the intrinsic motivation of all health care providers, which is shaped by their professional ethics, ongoing training, expectations and continuing education.

As dietitians it is part of our responsibility to look at a patient's entire continuum of care. When compiling a patient's medical history note medications and other problems that may be a red flag. Listen to what patients tells you and communicate with the patient's attending physician. Communication can become one essential key to decreasing risk. Everyone caring for a patient must keep their eyes and ears open. Proper documentation is also essential for verifying the quality of care delivered, determining outcomes of care and communicating with others on the health care team.

As health care professionals we are still human and we have to expect that some errors will occur. But it is our responsibility to do everything in our power to decrease the risk of any medical error to any patient. Learning all we can about the issue and staying abreast of new information and systems dealing with medical errors is a crucial first step. The issue of medical errors must continue to stay in the forefront of medical care until the problems are resolved and the statistical numbers drastically decrease.

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Section VIII. Bibliography of Additional Resources

Agency for Healthcare Research
The Agency for Healthcare Research and Quality (AHRQ) research provides evidence-based information on health care outcomes; quality; and cost, use, and access.
540 Gaither Road, Rockville, MD 20850
301-427-1364
http://www.ahcpr.gov/

The Joint Commission on Accreditation of Health Care Organizations
JCAHO evaluates the quality and safety of care for nearly 15,000 health care organizations. To maintain and earn accreditation, organizations must have an extensive on-site review by a team of JCAHO health care professionals, at least once every three years.
One Renaissance Blvd.
Oakbrook Terrace, IL 60181
630-792-5000
http://www.jcaho.org/

The Leapfrog Group
c/o AcademyHealth
1801 K Street NW, Suite 701-L
Washington, DC 20006
202-292-6713
www.leapfroggroup.org

The National Coordinating Council for Medication Error Reporting and Prevention
NCC MERP is an independent body comprised of 24 national organizations. In 1995, USP spearheaded the formation of the National Coordinating Council for Medication Error Reporting and Prevention. Leading national health care organizations are meeting, collaborating, and cooperating to address the interdisciplinary causes of errors and to promote the safe use of medications.
http://www.nccmerp.org/

US Food and Drug Administration
Accepts reports from consumers and health professionals about products regulated by the FDA, including drugs and medical devices, through MedWatch, the FDA's safety information and adverse event reporting program.
1-800-332-1088
www.fda.gov/medwatch/how.htm

U.S. Pharmacopeia
MEDMARX is an anonymous medication error-reporting program used by hospitals.
12601 Twinbrook Parkway Rockville, MD 20852, 1-800-822-8772
www.usp.org
www.medmarx.com

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Section IX: Footnotes

  1. U.S. News & World Report, Medical Errors Harm Huge Number of Patients [Website] accessed January 9, 2013. http://health.usnews.com/health-news/articles/2012/08/28/medical-errors-harm-huge-number-of-patients
  2. USA Today, Hospital errors more common than suspected [Website] Accessed January 11, 2013. http://usatoday30.usatoday.com/news/health/healthcare/health/healthcare/hospitals/story/2011/04/Report-Hospital-errors-more-common-than-suspected/45929932/1
  3. Premier Alliance Network, Medical errors and the Institute of Medicine (IOM) [Website] Accessed December 12, 2012. https://www.premierinc.com/safety/topics/patient_safety/index_1.jsp
  4. U.S. Food and Drug Administration, What is a Serious Event [Website] Accessed December 28, 2012. http://www.fda.gov/medwatch/report/DESK/advevnt.htm
  5. U.S. Food and Drug Administration, Med error reports to FDA show a mixed bag [Website] accessed December 29, 2012. http://www.fda.gov/ohrms/dockets/dailys/03/May03/052003/02N-0528-c000008-01.pdf
  6. U.S. Food and Drug Administration, Reduce Adverse Events Related to Medical Products [Website] Accessed November 26, 2012. http://www.fda.gov/Drugs/DrugSafety/MedicationErrors/default.htm
  7. Institute of Medicine, Preventing Medical Errors [Website] accessed December 29, 2012. http://www.iom.edu/~/media/Files/Report%20Files/1999/To-Err-is-Human/To%20Err%20is%20Human%201999%20%20report%20brief.ashx
  8. Medication Errors, The US Food and Drug Administration [Website] Accessed December 28, 2012. http://www.fda.gov/Drugs/DrugSafety/MedicationErrors/default.htm
  9. Institute of Medicine, Preventing Medication Errors [Website] Accessed January 10, 2013. http://www.iom.edu/~/media/Files/Report%20Files/2006/Preventing-Medication-Errors-Quality-Chasm-Series/medicationerrorsnew.pdf
  10. The New York Times, Report finds most errors at hospitals go unreported. Accessed January 9, 2013. http://www.nytimes.com/2012/01/06/health/study-of-medicare-patients-finds-most-hospital-errors-unreported.html
  11. Pharmacy Purchasing & Products, Reporting Medication Errors [Website] Accessed January 12, 2013. http://www.pppmag.com/article/1081/March_2012_IV_Safety/Reporting_Medication_Errors/
  12. Feature Article: Medication Errors - Volume 1, Number 4, Summer 2008, The US Food and Drug Administration [Website] Accessed December 12, 2012. http://www.fda.gov/Drugs/DrugSafety/DrugSafetyNewsletter/ucm120618.htm
  13. Timothy J. Hoff, Henry Pohl, Joel Bartfield, Implementing Safety Cultures in Medicine: What We Learn by Watching Physicians [Website] Accessed January 11, 2013. http://www.ahrq.gov/downloads/pub/advances/vol1/Hoff.pdf
  14. Agency for Healthcare Research and Quality, 30 Safe Practices for Better Health Care [Website] Accessed January 10, 2013. http://www.ahrq.gov/qual/30safe.htm
  15. Agency for Healthcare Research and Quality, 30 Safe Practices for Better Health Care [Website] Accessed December 30, 2012. http://www.ahrq.gov/qual/30safe.htm
  16. Carolyn M. Clancy, M.D. July 10, 2012 Revealing Medical Errors Helps Chicago Hospitals Build a Safer Health System [Website] Accessed January 6, 2013 http://www.ahrq.gov/consumer/cc/cc071012.htm
  17. U.S. News & World Report, Medical Errors Harm Huge Number of Patients [Website] Accessed December 27, 2012. http://health.usnews.com/health-news/articles/2012/08/28/medical-errors-harm-huge-number-of-patients
  18. The Joint Commission, Sentinel Event Data Summary as of June 30, 2012 [Website] Accessed January 14, 2013. http://www.jointcommission.org/sentinel_event.aspx
  19. Joint Commission on Accreditation of Healthcare Organizations, Sentinel Event Statistics - June 30, 2012 [Website] Accessed January 14, 2013. http://www.jointcommission.org/assets/1/18/General_Information_1995_2Q2012.pdf
  20. The Joint Commission, Summary Data of Sentinel Events Reviewed [Website] Accessed January 14, 2013. http://www.jointcommission.org/assets/1/18/Summary_2Q_2012.pdf
  21. The Joint Commission, Patient Safety Solutions, [Website] Accessed December 29, 2012. http://www.ccforpatientsafety.org/patient-safety-solutions/
  22. The Joint Commission Evolution of Performance Measurement at the Joint Commission 1986 - 2010: A Visioning Document [Website] Accessed January 11, 2013. http://www.jointcommission.org/assets/1/18/SIWG_Prologue_web_version.pdf
  23. Yale Journal of Health Policy, Law, and Ethics, National Survey of Medical Error Reporting Laws [Website] Accessed January 11, 2013. http://www.yale.edu/yjhple/issues/vix-i1-win09/docs/feature.pdf