Introduction

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.

These errors occur not only in hospital settings but also in doctor's offices, nursing homes, pharmacies, urgent care centers, and in home care. Medical mistakes can arise from the physician, health practitioner, specialist, hospital administration, nursing staff, pharmacists, pathology laboratories, pharmaceutical companies, and many others. The patient also has a responsibility in ensuring their safety in regards to health care. All of these factors add up to the fact that medical mistakes are sadly common. It is our job as health care professionals to do all we can to decrease the risk of medical errors to any patient. As a health care professional, understanding the prevalence and problems of medical errors, reporting errors, and learning about tracking systems that detect and help correct future medical errors is crucial. Much can be learned from the analysis of errors that do occur whether they result in harm to the patient or not.

There has been numerous systems set up on the national, federal and state levels to help produce a better understanding of the nature of patient safety problems and where exactly they occur in the delivery of health care. One example is The Agency for Healthcare Research and Quality (AHRQ), which has awarded large amounts of money for new grants, contracts, and other activities to fund research directly aimed at reducing medical errors and improving patient safety.

Medical errors can carry a high financial cost. The IOM report estimates that the cost of medical errors each year cost the nation approximately 37.6 billion dollars each year and about 17 billion dollars of these costs are directly associated with medical errors that are preventable. These costs are absorbed into the high medical costs that each and every one of us must pay. In addition to financial costs, medical errors can cost the medical community the trust and confidence that is expected from the public.

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. Discuss the 30 Safe Practices recommendations
3. Identify issues arising from different standards and measurements to reduce medical errors
4. Describe the role of organizations promoting patient safety and quality
5. Discuss medical error reduction programs
6. Describe barriers to preventing medical errors
7. Discuss the role of the national medical errors reporting programs
8. Explain the patient safety and medical errors prevention checklist

Medical Errors Prevalence

Attention to medical errors escalated over seven years ago with 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 cause 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.

Still, experts agree that there is much more work to do. For example, fewer than 3% of hospitals have implemented computerized drug ordering systems which one study found to reduce medication errors by 86%. In a December 2002 Kaiser Family Foundation survey, only 5% of physicians identified medical errors as a top health care concern. Shortly after the release of the 1999 IOM report, Congress gave $50 million to the U.S. Agency for Healthcare Research and Quality for research into the causes and prevention of medical errors.¹

Medical Errors Definition

The Institute of Medicine (IOM) defines medical errors and adverse events as:²

• Medical error - the failure to complete a planned action as intended or the use of a wrong plan to achieve an aim.
• Adverse event - an injury caused by medical management rather than by the underlying disease or condition of the patient.
• 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. The event is SERIOUS and should be reported when the patient outcome is:³
• 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. Examples: Pacemaker failure; gastrointestinal hemorrhage; bone marrow suppression; infusion pump failure which permits uncontrolled free flow resulting in excessive drug dosing.
• Hospitalization (initial or prolonged) - Report if admission to the hospital or prolongation of a hospital stay is a result of the adverse event. Examples: Anaphylaxis; pseudomembranous colitis; or bleeding causing or prolonging hospitalization.
• 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. Examples: Cerebrovascular accident due to drug-induced hypercoagulability; toxicity; peripheral neuropathy.
• 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. Examples: Vaginal cancer in female offspring from diethylstilbestrol during pregnancy; malformation in the offspring caused by thalidomide.
• 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. Examples: Acetaminophen overdose-induced hepatotoxicity requiring treatment with acetylcysteine to prevent permanent damage; burns from radiation equipment requiring drug therapy; breakage of a screw requiring replacement of hardware to prevent malunion of a fractured long bone.

Some adverse events are not preventable and they reflect the risk associated with treatment, such as a life-threatening allergic reaction to a drug when the patient had no known allergies to it. However, the patient who receives an antibiotic to which he or she is known to be allergic, goes into anaphylactic shock, and dies, represents a preventable adverse event.

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:⁴

• 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.

The Institute of Medicine report, Preventing Medication Errors (July 2006), 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.⁶

The report estimates that between 380,000 and 450,000 adverse drug reactions occur in the United States each year in hospitals alone while those numbers more than double in long term care facilities.

Medical Errors Root Causes

According to a variety of sources, the root cause of medical errors is due to the complexity of todays 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.⁷
• 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:⁸

• 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.⁹

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.¹⁰

National Standards

Hospitals have been faced with a wide array of different standards and guidelines required by the government, insurance companies, and accrediting agencies. This has lead to confusion as well as a high cost and the time spent trying to collect and analyze data.

In November 2006, National Quality Forum endorsed a 30 Safe Practices which cover a range of practices that, if utilized, would reduce the risk of harm in certain processes, systems or environments of care. The ultimate goal of these recommendations is to create a single set of standards for hospitals to improve safety.

Agency for Healthcare Research and Quality (AHRQ)

The National Quality Forum, with support from the Agency for Healthcare Research and Quality (AHRQ), has identified 30 safe practices that evidence shows can work to reduce or prevent adverse events and medical errors.¹¹

The Agency for Healthcare Research and Quality (AHRQ) is the lead Federal agency charged with improving the quality, safety, efficiency, and effectiveness of health care for all Americans. As one of 12 agencies within the Department of Health and Human Services, AHRQ supports health services research that will improve the quality of health care and promote evidence-based decisionmaking.

The mission of AHRQ is to improve the quality, safety, efficiency, and effectiveness of health care by:

• Using evidence to improve health care.
• Improving health care outcomes through research.
• Transforming research into practice. AHRQ's research is designed to address the most critical aspects of patient safety improvement:
• How to identify errors and their causes.
• Collect and report information on patient safety problems.
• Improve safety through the use of evidence-based interventions, tools, and practices, including health information technology.

The ultimate goal in the United States is to deliver safe, high-quality health care to patients in all clinical settings. Despite the best intentions, however, a high rate of largely preventable adverse events and medical errors occur that cause harm to patients. Adverse events and medical errors can occur in any health care setting in any community in this country.

National Quality Forum Safe Practices

The National Quality Forum is a private, non-profit public benefit corporation, created in 1999 in response to the need to develop and implement a national strategy for health care quality measurement and reporting. Established as a unique public-private partnership, the National Quality Forum has broad participation from more than 170 organizations that represent all sectors of the health care industry, including health care providers, consumers, employers, insurers, and other stakeholders.

Among its members are the AARP, AFL-CIO, the American Hospital Association, the American Medical Association, the American Nurses Association, the American Society of Health-System Pharmacists, the Ford Motor Company, and General Motors.

30 Safe Practices for Improving Patient Safety

The National Quality Forum-endorsed 30 Safe Practices cover a range of practices that, if utilized, would 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 safe medication use.¹²

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.¹³

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.

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.

Voluntary Guidelines

Although the guidelines are voluntary it will likely be incorporated into programs that reward those institutions that do implement the guidelines and penalize those that don't. This will also benefit the consumer because the guidelines will create a standardized report card to use in comparing the hospitals performance.

Some of the current groups that are promoting patient safety and quality include:

• The Leapfrog Group - Growing consortium of Fortune 500 companies and other large private and public healthcare purchasers provide health benefits to more than 37 million Americans in all 50 states. Survey hospitals for safety and quality.
• Joint Commission on Accreditation of Healthcare Organizations (JCAHO) - Evaluates and accredits nearly 15,000 health care organizations and programs in the United States.
• The American Nurses Association - Largest and most prestigious nursing credentialing organization in the United States.

The Leapfrog Group

The Leapfrog Group is a voluntary program aimed at mobilizing employer purchasing power to alert America's health industry that big leaps in health care safety, quality and customer value will be recognized and rewarded. Among other initiatives, Leapfrog works with its employer members to encourage transparency and easy access to health care information as well as rewards for hospitals that have a proven record of high quality care.

The Leapfrog Group's mission is to trigger giant leaps forward in the safety, quality and affordability of health care by:

• Supporting informed healthcare decisions by those who use and pay for health care; and,
• Promoting high-value health care through incentives and rewards.

The National Quality Forum Safe Practices Leap

There are many aspects of a hospital's operations that contribute to overall quality and safety of care. In an effort to recognize a more expansive set of hospitals' quality and safety activities, and bring information to consumers about the level of safety they can expect, The Leapfrog Group has created a new leap based on the National Quality Forum's (NQF) Safe Practices for Better Healthcare: A Consensus Report.

Included in the 30 practices are the original 3 Leapfrog leaps: Computer physician order entry, ICU physician staffing and Evidence-based Hospital Referral for certain high-risk procedures. For this new Leap, hospitals' progress on the remaining 27 safe practices will be assessed. After completion of the online Leapfrog hospital survey, each hospital's relative ranking compared with other hospitals will be displayed on the Leapfrog Web site, along with their results for the initial 3 Leaps. Hospitals may choose to update their survey monthly.¹⁴

Leapfrog's initial 3 Leaps targeted urban hospitals. Non-urban hospitals are now invited on a voluntary basis to complete the survey for the NQF Safe Practices Leap. They may also choose to complete the survey for the first 3 Leaps. Results of submitted surveys will be posted on The Leapfrog Group Web site.

Safe Practices Measurements

The Texas Medical Institute of Technology (TMIT)2, on behalf of The Leapfrog Group, consulted more than 100 clinical, administrative, and scientific experts to assess the NQF-endorsed Safe Practices and to develop the survey and hospital ranking system. The relative weightings for each individual safe practice were developed by the TMIT Medical Advisory Board, which consisted of 10 internationally recognized patient safety leaders.

Pediatric Task Forces were established to address the unique aspects of these hospitals.

Leapfrog scores hospitals' progress on the 27 NQF Safe Practice areas out of a total of 1,000 points. Each practice area is assigned an individual weight, which is factored into the overall score. Hospitals are then ranked by quartiles. The final ranking will be defined by one of four categories to be publicly displayed on the Leapfrog Group Web site.

Partial credit for partial progress and partial credit for commitments towards progress may be earned in each of 4 dimensions of adoption: awareness, accountability, ability, and action. For example, of 263 total possible points for progress on Practice #1 (Create a Healthcare Culture of Safety); a hospital may earn partial credit for partial progress and partial credit for commitment to undertake activities, in addition to credit earned for existing actions.

A hospital's total score will be used to initially rank hospitals into one of four groups:

1. Fully meets progress goal
2. Making good progress
3. Good early stage effort
4. Willingness to report

In order to achieve the highest level of recognition, a hospital must be in the top quartile of respondents and must have made real progress in those practices considered most significant by the expert panels. Full details regarding the survey, relative weighting, and ranking method is on The Leapfrog Group Web site at www.leapfroggroup.org

Challenges to Implementation

It is unlikely that hospitals will fully satisfy all practice requirements, including the most sophisticated and well resourced; some hospitals do not have the financial and staff resources to direct at every safe practice; other hospitals simply have not directed their resources toward these patient safety practices. It is expected that completion of the survey will help to initiate a change process through the four dimensions of progress: awareness, ability, accountability and action that, if followed, will increase a hospital's investment in structural, process and clinical improvement aimed at patient safety.

A major challenge for hospitals has been the lack of national standards and measures resulting in duplicative or widely scattered efforts to meet slightly different standards for each quality and safety organization. This Leap utilizes consensus-based nationally endorsed standards, increasing the efficiency and coordination of hospital reporting.

Why Purchasers Need to Get Involved

Using their leverage as purchasers, Leapfrog members can recognize and reward hospitals that meet NQF-endorsed Safe Practices standards. The addition of this fourth leap gives more tools with which to measure and reward hospital performance, and extends the reach of the survey to rural as well as urban hospitals, covering more of the hospitals providing services to purchasers and plans.

Purchasers, including health plans, can promote the NQF Safe Practices Leap by educating employees and consumers and calling attention to the importance of choosing the right hospital.

Purchasers through their community involvement in health care settings (as board members, volunteers, donors) can also be persuasive with health care providers about the need to extend their efforts in safety and quality.

Purchasers can also contract for specific safety and quality improvements with their health care providers and health plans, Public reporting of the results of The Leapfrog Group survey can serve to both inform and motivate improvements in the safety of care.

Benefits

Unfortunately, there is continued evidence of problems in patient safety and the quality of care in inpatient settings. The NQF Safe Practices were endorsed by a broad group of stakeholders to provide high-impact improvements in patient safety. The criteria used to select these practices included reduction in mortality, experiential data from clinical practice and transferable evidence from other industries where research had shown efficacy. The implementation of these practices can reduce harm and save lives. Making hospital results available on the level of implementation will make more information available to consumers, enabling them to make more informed hospital choices.

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.¹⁵

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 30, 2006

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.¹⁶

The majority of sentinel events occur in hospitals. There were a total of 3,811 sentinel events reported in 2006. The following chart shows the number and percentage of the total sentinel events listed by type of facility.

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.

Changes to the Goals and Requirements are indicated in bold. Gaps in the numbering indicate that the Goal is inapplicable to the program or has been "retired," usually because the requirements were integrated into the standards.

Goal 1 Improve the accuracy of patient identification.

Goal 2 Improve the effectiveness of communication among caregivers.

2A - For verbal or telephone orders or for telephonic reporting of critical test results, verify the complete order or test result by having the person receiving the information record and "read-back" the complete order or test result.

2B - Standardize a list of abbreviations, acronyms, symbols, and dose designations that are not to be used throughout the organization.

2C - Measure, assess and, if appropriate, take action to improve the timeliness of reporting, and the timeliness of receipt by the responsible licensed caregiver, of critical test results and values.

2E - Implement a standardized approach to "hand off" communications, including an opportunity to ask and respond to questions.

Goal 3 Improve the safety of using medications.

3B - Standardize and limit the number of drug concentrations used by the organization.

3C - Identify and, at a minimum, annually review a list of look-alike/sound-alike drugs used by the organization, and take action to prevent errors involving the interchange of these drugs.

3D - Label all medications, medication containers (for example, syringes, medicine cups, basins), or other solutions on and off the sterile field.

Goal 7 Reduce the risk of health care-associated infections.

7A - Comply with current Centers for Disease Control and Prevention (CDC) hand hygiene guidelines.

7B - Manage as sentinel events all identified cases of unanticipated death or major permanent loss of function associated with a health care-associated infection.

Goal 8 Accurately and completely reconcile medications across the continuum of care.

8A - There is a process for comparing the patient's current medications with those ordered for the patient while under the care of the organization.

8B - A complete list of the patient's medications is communicated to the next provider of service when a patient is referred or transferred to another setting, service, practitioner or level of care within or outside the organization. The complete list of medications is also provided to the patient on discharge from the facility.

Goal 9 Reduce the risk of patient harm resulting from falls.

9B - Implement a fall reduction program including an evaluation of the effectiveness of the program.

Goal 13 Encourage patients' active involvement in their own care as a patient safety strategy.

13A -Define and communicate the means for patients and their families to report concerns about safety and encourage them to do so.

Goal 15 The organization identifies safety risks inherent in its patient population.

15A - The organization identifies patients at risk for suicide. [Applicable to psychiatric hospitals and patients being treated for emotional or behavioral disorders in general hospitals.]

An example of the policies adopted to support the National Patient Safety goals the Joint Commission implemented its "do not use" list of abbreviations. The list was created by the Joint Commission as part of the requirements for meeting National Patient Safety Goal (NPSG) requirement 2B (Standardize a list of abbreviations, acronyms and symbols that are not to be used throughout the organization)¹⁷.

The following is a partial list of the abbreviations that are recommended as future inclusion in the "Do Not Use" list.¹⁸

As part of the Joint Commissions continuous effort to improve the standards, the Joint Commission has launched a Standards Improvement Initiative to make the standards more clear, objective, and program-specific, and to refine the scoring of the standards.

Improvements-both structural and language changes-are targeted to go into effect January 2009 for the ambulatory, critical access hospital, home care, hospital, and office-based surgery programs.

The American Nurses Association

The American Nurses Association (ANA) is the largest and most prestigious nursing credentialing organization in the United States and has a long tradition of providing programs that establish respect for nurses and the profession. American Nurses Credentialing Center (ANCC) certifications are highly regarded across the nation by federal, state and local agencies.

To accomplish its mission, ANCC:

• Certifies healthcare providers;
• Accredits educational providers, approvers, and programs;
• Recognizes excellence in nursing and healthcare services;
• Educates the public, and collaborates with organizations to advance the understanding of credentialing services; and
• Supports credentialing through research, education, and consultative services.

The Magnet Recognition Program®

The Magnet Recognition Program® was developed by the American Nurses Credentialing Center to recognize health care organizations that provide the very best in nursing care and uphold the tradition within nursing of professional nursing practice. The program also provides a vehicle for disseminating successful practices and strategies among nursing systems.

The Objectives of the Magnet Recognition Program® are to recognize nursing services that use the Scope and Standards for Nurse Administrators (ANA, 2003) to build programs of nursing excellence for the delivery of nursing care to patients that:

• Promote quality in a milieu that supports professional nursing practice
• Provide a vehicle for the dissemination of successful nursing practices and strategies among health care organizations using the services of registered professional nurses
• Promote positive patient outcomes

Regardless of the health-care organization's size, setting, or location, achieving Magnet designation serves to attract and retain quality employees. Magnet designation helps consumers locate health care organizations that have a proven level of excellence in nursing care. "In an environment rife with controversy about patient safety in hospitals, medical error rates, and nursing shortages, consumers need to know how good the care is at their local hospitals. [Magnet is] a seal of approval for quality nursing care."¹⁹

The Commission on Magnet Recognition Program® recognizes more than 200 health-care organizations in 41 states, as well as one abroad, for their excellence in nursing service.²⁰

Systems Improvements

Research has shown that system improvements can reduce the error rates and improve the quality of health care:²¹

• A 1999 study indicated that including a pharmacist on medical rounds reduced the errors related to medication ordering by 66 percent, from 10.4 per 1,000 patient days to 3.5 per 1,000 patient days.
• The specialty of anesthesia has reduced its error rate by nearly sevenfold, from 25 to 50 per million to 5.4 per million, by using standardized guidelines and protocols, standardizing equipment, etc.
• One hospital in the Department of Veterans Affairs uses hand-held, wireless computer technology and bar-coding, which has cut overall hospital medication error rates by 70 percent. This system is soon to be implemented in all VA hospitals.
• Implementing a new computerized system for detecting potentially dangerous drug combinations at Barnes-Jewish Hospital in St. Louis has resulted in a 66 percent reduction in potentially unsafe combinations with cisapride, a gastrointestinal drug.

When a medical error occurs in a hospital, a risk manager examines the system and takes preventive steps. Often these incidents are not reported or shared with other hospitals, health care professionals, the FDA or drug manufacturers. Unless these incidents are reported, the FDA cannot take action to prevent them. Reporting medical errors and examining the causes is a step toward prevention.

Hospitals and other health care organizations are working to reduce medical errors by using technology, improving processes, zeroing in on errors that cause harm, and building a culture of safety. Here are a few examples from the Institute for Safe Medication Practices (ISMP).²²

• Pharmacy intervention - It was a challenge for health care providers, especially surgeons, at Fairview Southdale Hospital in Edina, MN, to ensure that patients continued taking their regularly prescribed medicines when they entered the hospital, says Steven Meisel, Pharm.D., director of medication safety at Fairview Health Services. "Surgeons are not typically the original prescribers," he says. The solution was to have pharmacy technicians record complete medication histories on a form. In a pilot program, the technicians called most patients on the phone a couple of days before surgery. A pharmacist reviewed the information and then the surgeon decided which medications should be continued. After three months, the number of order errors per patient dropped by 84 percent, and the pilot program became permanent.
• Computerized Physician Order Entry (CPOE) - Studies have shown that 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 Corporation 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."²³

The FDA enhanced its efforts to reduce medication errors by dedicating more resources to drug safety, which included forming a new division on medication errors at the agency last year. Here's a look at key areas in which the FDA is working to reduce medication errors.²⁴

• Bar code label rule: After a public meeting in July 2002, the FDA decided to propose a new rule requiring bar codes on certain drug and biological product labels. Health care professionals would use bar code scanning equipment, similar to that used in supermarkets, to make sure that the right drug in the right dose and route of administration is given to the right patient at the right time.

The VA medical center in Topeka, KN, has reported that bar coding reduced its medication error rate by 86 percent over a nine-year period.

Here's how it works: When patients enter the hospital, they get a bar-coded identification wristband that can transmit information to the hospital's computer, says Lottie Lockett, R.N., a nursing administrator at the Houston VA Medical Center. Nurses have laptop computers and scanners on top of medication carts that they bring to patients' rooms. Nurses use the scanners to scan the patient's wristband and the medications to be given. The bar codes provide unique, identifying information about drugs given at the patient's bedside. "Before giving medications, nurses use the scanner to pull up a patient's full name and social security number on the laptops, along with the medications," Lockett says. "If there is not a match between the patient and the medication or some other problem, a warning box pops up on the screen."

The FDA's proposed rule on bar code labeling was published on March 14, 2003. The rule, which took effect in 2006, applies to prescription drugs, biological products such as vaccines, blood and blood components, and over-the-counter (OTC) drugs that are commonly used in hospitals. Manufacturers, repackers, relabelers, and private label distributors of prescription and OTC drugs would be subject to the bar code requirements. The agency continues to study whether it should also develop a rule requiring bar code labeling on medical devices.

• Drug name confusion: To minimize confusion between drug names that look or sound alike, the FDA reviews about 300 drug names a year before they are marketed. The FDA rejects about one-third of the names that drug companies propose. The agency tests drug names with the help of about 120 FDA health professionals who volunteer to simulate real-life drug order situations.

After drugs are approved, the FDA tracks report of errors due to drug name confusion and spreads the word to health professionals, along with recommendations for avoiding future problems. For example, due to confusion between Ortho-McNeil's Reminyl (indicated for Alzheimer's disease) and Sanofi-Aventis' Amaryl® (indicated for diabetes), Ortho-McNeil now markets Reminyl under the new trade name Razadyne. Based on reports submitted to FDA and USP, prescriptions for Reminyl have been incorrectly written, interpreted, labeled or filled, leading to confusion between Reminyl and Amaryl. Consequently, the administration of Amaryl to Alzheimer's patients, who did not have diabetes resulted in serious events, including severe hypoglycemia and-in two cases-death.²⁵

• Drug labeling: Consumers tend to overlook important label information on OTC drugs, according to a Harris Interactive Market Research Poll conducted for the National Council on Patient Information and Education and released in January 2002. In May 2002, an FDA regulation went into effect that requires a standardized "Drug Facts" label on more than 100,000 OTC drug products. Modeled after the Nutrition Facts label on foods, the label helps consumers compare and select OTC medicines and follow instructions. The label clearly lists active ingredients, uses, warnings, dosage, directions, other information, such as how to store the medicine, and inactive ingredients.

As for health professionals, the FDA proposed a new format in 2000 to improve prescription drug labeling for physicians, also known as the package insert. One FDA study showed that practitioners found the labeling to be lengthy, complex, and hard to use. The proposed redesign would feature a user-friendly format and would highlight critical information more clearly. The FDA is still reviewing public comments on this proposed rule. The agency has also been working on a project called DailyMed, a computer system that will be available without cost from the National Library of Medicine next year. DailyMed will have new information added daily, and will allow health professionals to pull up drug warnings and label changes electronically.

• Error tracking and public education: The FDA HAS announced a proposed rule that would revamp safety-reporting requirements. For example, the proposal would require that reports on actual and potential medication errors be submitted to the agency within 15 calendar days. This rule is part of FDA's overall effort to understand the sources of medication errors and prevent them.

  The FDA reviews medication error reports that come from drug manufacturers and through MedWatch, the agency's safety information and adverse event reporting program. The agency also receives reports from the Institute for Safe Medication Practices (ISMP) and the U.S. Pharmacopeia, or USP.

  The FDA receives and reviews about 250 medication error reports each month, and classifies them to determine the cause and type of error. Depending on the findings, the FDA can change the way it labels, names, or packages a drug product. In addition, once a problem is discovered, the FDA educates the public on an ongoing basis to prevent repeat errors.

  ISMP reports medication errors through various newsletters that target health professionals in acute care, nursing, and community/ambulatory care. ISMP launched a newsletter for consumers called Safe Medicine.

Process Improvement

Some hospitals have adopted methods to prevent medical errors and improve safety from process redesign strategies used in industries such as airlines and manufacturing. For example, many are adopting the Six Sigma program for reducing manufacturing defects, using workflow charts and audits to see where mistakes, errors, and delays happen, or to speed up slow moving processes such as the delivery of critical test results.

During shift changes nurses are using communications models adapted from a program to quickly brief submariners during a change in command. However the Joint Commission reports that as few as 10% of hospitals have comprehensive safety program that use formal methods, and 15% to 30% of them aren't compliant with standards such as making sure patient errors aren't made in the hand-offs between shits, reporting critical test errors in a timely manner, reading back verbal orders to ensure accuracy and making more staffers wash their hands.²⁶

Hospitalists

Hospitalists are a new breed of doctor whose sole responsibility is the care of hospitalized patients from admission through discharge. The fields growth reflects efforts by hospitals to cut costs, reduce the number of medical errors, and improve the general quality of care. They coordinate care by all staffers from nurses to specialists, order up tests, make treatment decision in consultation with primary care doctors, and are trained to recognize and respond quickly to changes in a patient's condition.

Hospitals that use them have cut average costs and average length of stay (ALOS) by 13.4 percent and 16.6 percent respectively, according to an article by Robert Wachter, MD, and Lee Goldman, MD, in the Jan. 23, 2002, Journal of the American Medical Association. Hospitalist programs have gone beyond the big-city medical centers and physician groups where one expects to find them. Pitt County Memorial Hospital in rural eastern North Carolina saw ALOS and charges drop by 35 percent five months after implementing a hospitalist program in late 2001. At the University of Chicago's hospital found that hospitalists reduced overall costs and cut-down on risk adjusted 30- day mortality rates by 37%.²⁷

The Society of Hospital Medicine (SHM) is the leading national organization providing resources and a voice for Hospitalists. The Society of Hospital Medicine is dedicated to promoting the highest quality care for all hospitalized patients. SHM is committed to promoting excellence in the practice of Hospital Medicine through education, advocacy, and research. The goals of the SHM are:²⁸

• To promote high quality care for all hospitalized patients.
• To promote education and research in Hospital Medicine.
• To promote teamwork to achieve the best possible care for hospitalized patients.
• To advocate a career path which will attract and retain the highest quality hospitalists.
• To define the competencies, activities, and needs of the hospitalist community.
• To support, propose, and promote changes to the health care system that lead to higher quality and more efficient care for all hospitalized patients.

SHM conducted a census of hospitalists and hospital medicine groups in 2003 and were able to identify over 8,000 hospitalists. This same survey identified over 1,800 hospital medical groups. In a recent survey by SHM, it appears that the average hospital medical group has 7-8 hospitalists. However, it is estimated that there are between 10,000-12,000 practicing hospitalists today, with the number expected to grow to 30,000 in the next decade.

Barriers to Preventing Medical Errors

There are many barriers to eliminating medical errors in the hospital, health facility and the non-hospital settings. The Quality Interagency Coordination Task Force (QuIC) report to the President, lists the following barriers to preventing the incidence of medical errors:²⁹

• Lack of awareness. The existence of medical errors has been known for some time. However, the fact that there has been very little success in reducing errors suggests that a general lack of awareness or alarm about errors is a factor in this failure. The awareness of the problem of medical errors and any subsequent solutions must be improved, not only among physicians, nurses, pharmacists, dentists, dietitians and other health care providers, but also among patients, policymakers, and the many other stakeholders of the health care community.
• Barriers to partnership. The punitive and pejorative connotations of "error" as the object of investigation pose a potential barrier to the unfettered cooperation and collaboration of health care providers in establishing and managing effective error control programs. A cultural change needs to occur that will enable health care providers and leaders, as well as the public, to talk about errors and recognize that they are, in large measure, a result of faulty systems and faulty system design, not of individual failures.
• Legal barriers. A system, which supports learning from errors, is dependent upon reporting, but fear of reprisal or legal action will dissuade many potential reporters. Assurances that the identity of reporters will be masked or never collected at all have been shown to enhance reporting in other industries. Disclosure of the individuals or organizations involved in an incident could also discourage reporting. There will remain instances, however, where criminal or negligent acts demand appropriate disclosure. The legal issues surrounding patient safety will have to be examined carefully to determine the best mechanisms to promote learning from errors while protecting the public.
• Information systems and technical problems. To be practical, error prevention will need to rely on sophisticated management and clinical information systems, both as sources of data on adverse events and as a component of interventions to reduce errors, such as through the adoption of computer-based decision-support for health care providers. However, information systems in most health care organizations are neither sufficiently integrated nor flexible enough to serve either of these purposes. Technical support and research into information system design will be required to address this problem.
• Cost and structural concerns. Although considerable cost savings could be realized by effective reduction in medical errors, instituting such programs will require a substantial initial investment. In addition, the relative autonomy of departments within some health care institutions is a potential barrier to rapid organizational change and the adoption of new models and procedures needed to prevent errors.
• Deficiencies in knowledge and understanding. The epidemiology of errors is not well understood. Standardized definitions of errors and adverse events need to be developed and the methods of collecting meaningful data require further study. Research is needed to help distinguish between adverse events due to errors, unavoidable consequences of treatment, and complications caused by a patient's underlying disease. The current paucity of fundamental and applied research on medical errors limits the tool kit of effective interventions that can enhance patient safety.
• Lack of appropriate collaboration among disciplines. Because of the nature of medical errors, an effective response requires an integration of efforts across traditional occupational and scientific boundaries. The nature of the patient safety challenge requires synergy among scientific and technical disciplines, from human factors such as psychology to product design and delivery. This collaboration is needed at all stages of the effort to reduce errors and enhance patient safety-from research on its causes and remedies to implementation and partnership in its reduction and elimination. The response to medical errors by the health care system is hindered by the traditional focus of single disciplines on individual providers or on products, and even by poorly coordinated efforts among Government agencies and with the private sector.
• Failure to apply a coherent strategy. The variety of medical errors and the multidimensional nature of the patient safety challenge demand a variety of approaches for improvement. Experience from other industries demonstrates, however, that successful interventions to address different types of errors can consistently result from the application of a coherent strategy that includes intolerance of high rates of error, development of tracking mechanisms, root cause analysis, the application of innovative resources and relationships to address the problem, and an institutional devotion to error prevention.

There are even greater barriers to error reduction in non-hospital settings, where the general absence of organized surveillance systems and lack of adequate personnel hinder local data collection, feedback, and improvement.

The report concludes that systems designed to facilitate quality improvement through error reduction can generate effective, useful reporting if those individuals who report are assured of confidentiality, protected from legal liability resulting from the report, provided with timely feedback on data from the system, and are not unduly burdened by the effort involved in reporting.

Cultural Diversity & Medication Safety

U.S. Census reports show that 1 in 4 Americans are of a race other than white; 1 in 3 children are African American, Hispanic, or Asian; and 1 in 10 people are foreign-born.1 This cultural diversity can have implications for medication safety. Ethnic culture affects our beliefs about health, illness, and medications, as well as how we interact with healthcare providers, comply with prescribed medications, and respond physiologically to medications. ³⁰ While the U.S. ethnic differences are endless, a few common themes found in the literature are provided below as examples. However, it's unwise, even false and prejudicial, to assume that everyone from a certain culture will respond the same way.

Levy and Hawks published a monogram on Cultural Diversity and Pharmaceutical Care, which summarizes the following issues:³¹

• Beliefs about health, illness, and medications. When illness or injury strikes, white patients are typically intolerant to pain, unlike many other cultures, where pain is seen as part of life. White patients also have a high expectation that their disease will be cured, or at least well managed, through technology and powerful drugs. In fact, most white Americans expect to leave the doctor's office with a prescription, and often believe that the management of microbes is more important than bolstering resistance to them. Thus, American medicine tends to be aggressive, with primary focus on the effectiveness of treatment, and a fairly high tolerance of side effects. In Japan, a drug's safety profile is stressed more than its effectiveness, which explains the general use of lower doses and fewer reported side effects. European medicine reflects a mid-position between American and Japanese medical cultures. Immigrants from different cultures may, therefore, have different expectations regarding the type of drug prescribed, dosages, and tolerance of side effects.

For example, while Hispanics, Chinese, and Asians often expect quick relief from symptoms, they are cautious about American medicines and often initiate downward dosage adjustments to avoid even minor side effects. The Chinese also consider American medicine to be quick and effective in removing symptoms, but not a permanent cure. Since they believe that traditional Chinese medicine can remove the cause of the illness, they often use American medicine for acute illness, surgery, and severe disease, and rely on Chinese medicine for long-term treatment.

• Interaction with health care providers. When dealing with white providers, minority patients often find eye contact, body posture, and other forms of nonverbal communication significant, especially if a language barrier is present. For Asian patients, who may be accustomed to a formal relationship with their health care providers, a casual appearance, attire, or attitude may damage the development of a trusting relationship. Even when comfortable with health care providers, some Asian or Hispanic patients may be reluctant to speak up about their illness. Out of misplaced deference for doctors and a reluctance to share deeply personal information, they may minimize or conceal adverse events, or stop taking medications because of the side effects without telling their providers. Family involvement may be important, too. In Hispanic families, the mother or grandmother (of the husband especially) usually makes the health care decisions, and the opinions of Asian family members and elders are greatly respected during illness.
• Adherence with prescribed medications. Ethnic beliefs may play a role in the early discontinuation of a prescribed medication. For example, African Americans and Native Americans often doubt the need for medications when symptoms ease, and may discontinue drugs like antibiotics and antidepressants. In some developing countries, medications are customarily prescribed for just a few days. This knowledge may thwart the acceptance of drugs with a delayed onset of action, such as antidepressants. Hispanics also tend to believe that the lack of symptoms means they are cured. This could be especially problematic in treating diabetes, a prevalent illness in the Hispanic community. When symptoms abate, patients often stop taking their medication. Diabetes is a challenge for Asian Americans, too. The disease is uncommon in Asia, so it's difficult for patients to grasp the relationship between blood sugar and diet. Dietary requirements also do not fit well with the Asian way of thinking about food.
• Cultural preferences, rituals, or fears may also affect adherence with medications. Women from Islamic and African cultures who have vaginal yeast infections may prefer oral drugs to vaginally inserted medications. Latin Americans expect injections, so they may believe that oral medications are less effective. Some cultures practice religious fasting, which can affect medication schedules or interfere with drug absorption. Mexican and Puerto Rican patients' concern about the addictive effects of medications can lead to reluctance to take long-term medications. Vietnamese patients have taken only half of their prescribed medication, believing it's too strong.
• Physiologic response to medications. A patient's race or ethnic background influences how medications are metabolized. Common genetic polymorphisms (multiple forms of enzymes used for drug metabolism) affect the metabolism of many important medications. For some polymorphisms, the proportion of rapid metabolizers and slow metabolizers varies based on ethnicity. For example, only 3 to 5 percent of whites are poor metabolizers of drugs affected by mephenytoin polymorphism (e.g., diazepam, imipramine), but 15 to 20 percent of Chinese and Japanese are poor metabolizes of mephenytoin and related drugs. Clinically, there may be an increase or decrease in the expected drug effect, so dosage adjustments may be necessary.

For example, Asians and Eskimos need lower doses of anxiolytics than white patients. Asians, Indians, and Pakistanis require lower doses of lithium and antipsychotic drugs. African Americans' symptoms generally improve faster after taking neuroleptics and anxiolytics. Hispanics may require lower doses of antidepressants than whites. Since different metabolic pathways often clear various drugs within the same class, ethnic differences in the metabolism of specific drugs may differ within a class.

The author notes that pointing out ethnic differences can be a touchy subject because of fear of offending people. However, these examples of ethnic diversity serve only to point out that we are all members of an ethnic group, each with cultural values that influence our behavior and physiologic response to medications. That knowledge should help us avoid a "we/they" attitude when caring for patients from a different culture than our own. The large number of ethnic cultures in America makes it hard to be culturally competent. But we can approach patients with respect while assessing their likelihood of acting on cultural beliefs that could adversely affect treatment outcomes. Individuals who are recent immigrants; live in ethnic enclaves; prefer using their native tongue; travel frequently to that country; and have frequent contact with others within their ethnic group are more likely to follow strongly held cultural beliefs. While misinformation or lack of information should be addressed, we should strive to bring effective health care to patients within a psychosocial context that is appropriate for their culture.³²

MEDMARX®

MEDMARX® is a national, Internet-accessible database that hospitals and health care systems use to track and trend adverse drug reactions and medication errors. Hospitals and health care systems participate in MEDMARX voluntarily and subscribe to it on an annual basis. MEDMARX is a quality improvement tool, which facilitates productive and efficient documentation, reporting, analysis, tracking, trending, and prevention of adverse drug events.

MEDMARX allows subscribing facilities to learn valuable lessons from the experiences of other users. Subscribers can access data from a national database of more than 1.1 million adverse drug event records. The data within MEDMARX follows standardized definitions. This allows easy and insightful comparisons to data and solutions from other similar organizations, trend analyses, and the development of best practices to prevent adverse drug events.

MEDMARX allows participating hospitals and health systems to:

• Improve patient safety and continually raise the standard of patient care.
• Move towards a systems-based approach to patient safety through comprehensive data collection, analysis, and process improvement.
• Prevent medication errors and adverse drug reactions through proactive measures to identify potential problem areas and initiate action plans.
• Eliminate the high costs and risks associated with medication errors and adverse drug reactions.
• Learn from the experiences of other similar organizations.
• Gain insight into trends and best practices from a comprehensive national database.
• Generate robust, easy-to-use, up-to-the-minute reports for management and committee meetings.
• Improve staff morale and sustain the highest professional values.
• Learn from and contribute to a leading national database.

National Coordinating Council for Medication Error Reporting and Prevention

The National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) is an independent body comprised of 22 national organizations including AARP, Joint Commission on Accreditation of Healthcare Organizations, American Medical Association, Food and Drug Administration, and the Food and Drug Administration.

The mission of the NCC MERP is to maximize the safe use of medications amongst all stakeholders and to increase awareness of medication errors through open communication, promotion of medication error prevention strategies, and increased reporting.

The Council intends to mount a nationwide campaign for medication error reporting and prevention that will promote recommendations broadly to colleges, schools, and state associations of medicine, pharmacy, and nursing; national professional associations; managed care organizations; and third-party payers.

The Councils objectives are to implement programs for:

1. Medication Error Reporting
2. Medication Error Understanding
3. Medication Error Prevention

The Council's goals are to provide the foundation on which all of their recommendations will be constructed, promoted, and implemented:

• To stimulate the development and use of medication error reporting and evaluation systems in individual health care organizations.
• To stimulate reporting to a national system for review, analysis, and development of recommendations to reduce and prevent medication errors.
• To examine and evaluate the causes of medication errors.
• To increase awareness of medication errors and methods of prevention throughout the health care system, which includes health care organizations and facilities, delivery systems, practitioners, manufacturers, regulators, and consumers.
• To recommend strategies relative to system modifications, practice standards and guidelines, and changes in packaging, labeling, and product identity.

Healthcare professionals who encounter actual or potential medication errors are encouraged to report them confidentially-and anonymously, if preferred-to USP's Medication Errors Reporting Program. Types of errors that may be reported include:³³

• Misinterpretations
• Miscalculations
• Misadministrations
• Difficulty in interpreting handwritten orders
• Misunderstanding of verbal orders

By reporting errors, pharmacists, nurses, physicians, and other healthcare practitioners contribute to improved patient safety and to the development of valuable educational services for the prevention of future errors.

As an FDA MedWatch partner, USP reviews each medication error report it receives for health hazards and forwards all information to the Food and Drug Administration and the product manufacturer. USP will act as your liaison with the FDA and the manufacturer should you wish to submit a report anonymously.

MedWatch

FDA has the responsibility for assuring the safety and efficacy of all regulated marketed medical products.

MedWatch, the FDA Safety Information and Adverse Event Reporting Program, serves both healthcare professionals and the medical product-using public. They provide important and timely clinical information about safety issues involving medical products, including prescription and over-the-counter drugs, biologics, medical and radiation-emitting devices, and special nutritional products (e.g., medical foods, dietary supplements and infant formulas).

Medical product safety alerts, recalls, withdrawals, and important labeling changes that may affect the health of all Americans are quickly disseminated to the medical community and the general public via this web site and the MedWatch E-list.

MedWatch allows healthcare professionals and consumers to report serious problems that they suspect are associated with the drugs and medical devices they prescribe, dispense, or use. Reporting can be done on line, by phone, or by submitting the MedWatch 3500 form by mail or fax.³⁴

American Dietetic Association Documentation

In American Dietetic Association's 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.³⁵

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 ADA 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 ADA 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.

Patient Involvement

The Institute of Medicine report on Preventing Medical Errors published in July 2006 concludes that one of the most effective ways to reduce medication errors is to move toward a model of health care where there is more of a partnership between the patients and the health care providers. 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. 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.³⁶

Patient Safety Checklist

An important role in the prevention of medical errors rests with the patient. The Agency for Healthcare Research and Quality (AHRQ) has developed the following list of recommendations for the patient to use in managing their treatment and preventing medical errors.

AHRQ reports that the single most important way the patient can help to prevent errors is to be an active member of their health care team. That means patients must take part in every decision about their health care. Research shows that patients who are more involved with their care tend to get better results.

The following are specific tips, based on the latest scientific evidence, about what works best.³⁷

Patient Safety Checklist

Medicines

• Make sure that all of the doctors know about all medications that are being taken. This includes prescription and over-the-counter medicines, and dietary supplements such as vitamins and herbs. At least once a year, it is recommended that the patient bring all of their medicines and supplements to their doctor. This allows the patient and the doctor to discuss them and find out if there are any problems. This will also help the doctor to keep their records up to date, which can help the patient receive better quality care.
• Make sure the doctor knows about any allergies and adverse reactions that the patient may have had to medicines. This can help the patient avoid receiving a medicine that can harm them.
• When a doctor writes the patient a prescription, make sure they can read it. If they can't read the doctor's handwriting, remember that the pharmacist might not be able to either.
• The patient should ask for information about the medicines in terms that they can understand-both when the medicines are prescribed and when they receive them. Questions to ask include:
• What is the medicine for?
• How is it supposed to be taken, and for how long?
• What side effects are likely? What do I do if they occur?
• Is this medicine safe to take with other medicines or dietary supplements that the patient may be taking?
• What food, drink, or activities should be avoided while taking this medicine?

• When patients pick up their medicine from the pharmacy, they should ask if this is the medicine that the doctor prescribed. A study by the Massachusetts College of Pharmacy and Allied Health Sciences found that 88 percent of medicine errors involved the wrong drug or the wrong dose.
• The patient should always ask if they have any questions about the directions on the medicine labels. Medicine labels can be hard to understand. For example, they should ask if "four doses daily" means taking a dose every 6 hours around the clock or just during regular waking hours.
• The patient should ask the pharmacist for the best device to measure liquid medicine. Research shows that many people do not understand the right way to measure liquid medicines. For example, many use household teaspoons, which often do not hold a true teaspoon of liquid. Special devices, like marked syringes, help people to measure the correct dose. Being told how to use the devices helps even more.
• The patient should ask for written information about any possible side effects the medicine could cause. If the patient is aware of what might happen, they will be better prepared if it does-or, if something unexpected happens instead. This will also aid the patient in reporting any problems immediately and getting help before the problem escalates. A study found that written information about medicines can help patients to recognize problem side effects and help them to communicate that information to their doctor or pharmacist.

Hospital Stays

• If the patient has a choice, they should choose a hospital that is highly experienced in the procedure or surgery that is needed. Research shows that patients tend to have better results when they are treated in hospitals that have a great deal of experience with their condition.
• If the patient is in a hospital, they should consider asking all health care workers who have direct contact with them whether they have washed their hands. Hand washing is one imperative way to prevent the spread of infections in hospitals. Yet, it is not done regularly or thoroughly enough. A recent study found that when patients checked whether health care workers washed their hands, the workers washed their hands more often and used more soap.
• When being discharged from the hospital, the patient should ask the doctor to thoroughly explain their home treatment plan. This includes information on medicines and discussing when the patient can get back to their regular activities. Research shows that at the time of discharge, doctors assume their patients understand more than they really do about what they should or should not do when they return home.

Surgery

• If having surgery, the patient should make sure that they are in agreement and are clear on exactly what will be done with both the doctor and the surgeon. Doing surgery at the wrong site (for example, operating on the left knee instead of the right) is rare. The American Academy of Orthopedic Surgeons urges its members to sign their initials directly on the site to be operated on before the surgery.

Other Recommended Steps

• The patient should speak up if they have any questions or concerns. The patient has a right to question anyone who is involved with his or her care.
• The patient should have someone, such as their personal doctor, in charge of their total care. This is especially important if they have multiple health problems or are in the hospital.
• All health professionals involved in the patient's care should have all pertinent health information about them. Do not assume that everyone knows everything they need to.
• The patient should ask a family member or friend to be there with them and to be their advocate (someone who can help get things done and speak up for the patient if they can't). Even if the patient doesn't think they need help now, they might need it later.
• Know that "more" is not always better. It is a good idea to find out why a test or treatment is needed and how it can help. The patient could be better off without it.
• If the patient has a test, don't assume that no news is good news. Be sure to ask about the results.
• The patient should learn about their condition and treatments by asking their doctor and nurse and by using other reliable sources. It never hurts to have a second opinion.

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 a patient 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 dietitians we are accountable for keeping current on the most recent trends of treatment and information available as well as keeping abreast of protocol set forth by organizations such as JCAHO.

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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