Prevention of Medical Errors

 

This course is approved by the the following boards within the State of Florida. (CE Provider #:50-4672)

The Florida Board of Registered Nursing

    •         Licensed Practical Nurse 
    •         Florida Board of Respiratory Care
    •         Respiratory Care Practitioner Critical Care 
    •         Respiratory Care Practitioner Non-Critical Care 
    •         Certified Respiratory Therapist 
    •         Registered Respiratory Therapist 
    •         Licensed Midwife 
    •         Florida Electrolysis Council
    •         Electrologist 
    •         Advanced Registered Nurse Practitioner
      • Florida Board of Nursing - Certified Nursing Assistants
      • Florida Council of Dietetics and Nutrition
      • Florida Physician Assistants

Approved by the Florida Board of Psychology

This course is not approved by the Florida Board of Clinical Social Work, Marriage and Family Therapy and Mental Health Counseling.

Learning Objectives

Upon completion of this course, the health care professional will be able to:

1.      Describe the magnitude of medical errors.

2.      Define the types of medical errors.

3.      Discuss factors that increase the risk of medical errors.

4.      Identify populations of special vulnerability.

5.      Discuss responsibilities for reporting medical errors.

6.      Identify processes to improve patient outcomes.

7.      Describe public education measures related to patient safety.

 

Introduction

In November 1999, the Institute of Medicine (IOM) revealed a hidden epidemic in the United States: medical errors, which result in injury to 1 in every 25 hospital patients and an estimated 44,000 to 98,000 deaths each year. Even the lower estimate makes medical errors more deadly than breast cancer (42,297), motor vehicle accidents (43,458) or AIDS (16,516). According to the IOM report, To Err is Human: Building a Safer Health System, medical errors cost the economy from $17 to $29 billion each year.

Research funded by the Agency for Healthcare Research and Quality (AHRQ) has shown that medical errors result most frequently from systems errors-organization of health care delivery and how resources are provided in the delivery system. Only rarely are medical errors the result of carelessness or misconduct of a single individual.

As John M. Eisenberg, MD, Director of AHRQ pointed out:

"Mistakes happen in hospitals, they happen in outpatient clinics, they happen in nursing homes and home care, and they happen in self-care. We as clinicians need to acknowledge that they happen. The challenge is to avoid them, and when mistakes do occur, to prevent them from causing harm to our patients." (2000)

Errors can occur at any point in the health care delivery system. Acknowledging that errors happen, learning from those errors, and working to prevent future errors represents a major change in the culture of health care, a shift from blame and punishment to analysis of the root causes of errors and strategies to improve systems and processes. Every person on the healthcare team has a role in making health care safer for patients and workers.

In response to the IOM report, the Florida State legislature mandated that all licensees must complete a two-hour course on prevention of medical errors, which meets the criteria of Florida Statute 456.013, for initial licensure and biennial renewal.

Types of Medical Errors

The IOM report defines an error as "the failure of a planned action to be completed as intended (i.e., error of execution) or the use of a wrong plan to achieve an aim (i.e., error of planning)."

An adverse event is an injury caused by medical management rather than the underlying condition of the patient. An adverse event attributable to error is a preventable adverse event, also called a sentinel event, because it signals the need to ask why the error occurred and make changes in the system.

Research on why humans make errors (Reason, 1990) has identified two types of errors: active errors and latent errors. Active errors tend to occur at the level of the individual and their effects are felt almost immediately. Latent errors are more likely to be beyond the control of the individual, that is, errors in system design, faulty installation or maintenance of equipment, or ineffective organizational infrastructure. The effects of latent errors may not appear for months or even years but they can lead to a cascade of active errors, ending in catastrophe. For example, an undetected design flaw in an airplane (a latent error) may cause the pilot to lose control of the plane (an active error) years after the aircraft was built, and cause the plane to crash.

Close calls or near misses are potential adverse events, errors that could have caused harm but did not, either by chance, or because something or someone in the system intervened. For example, a nurse who recognizes a potential drug overdose in a physician's prescription and does not administer the drug but instead calls the error to the physician's attention has prevented an adverse drug event (ADE). Close calls provide opportunities for developing preventive strategies and actions, and should receive the same level of scrutiny as adverse events.

Surgical Errors

Surgical errors, or surgical adverse events, may account for a high percentage of adverse events. A study of hospitals in Colorado and Utah (Gawande, et al, 1999) found that surgical adverse events accounted for two-thirds of all adverse events and 1 of 8 hospital deaths.

A review by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO, 1998) found that wrong-site surgery was most common in orthopedic procedures. Risk factors contributing to the error included more than one surgeon involved in the case, multiple procedures performed during a single operating room visit, and unusual time pressures, particularly pressure to speed up preoperative procedures.

Surgical errors such as wrong-site surgery are not the sole responsibility of the operating surgeon, however. All operating room personnel have a role in ensuring patient safety by verifying the surgical site and pointing out a possible error. Admittedly, this can be difficult in the presence of an attitude that the surgeon should never be questioned.

To reduce the risk of wrong-site surgeries, JCAHO recommends the following strategies:

  • Clearly mark the operative site, involving the patient (or the family when appropriate) in the marking process
  • Require oral verification of the correct site in the operating room by each member of the surgical team
  • Develop a verification checklist that lists all documents referencing the intended surgical procedure and site

Diagnostic Inaccuracies

An accurate diagnosis is the first requirement for correct and effective treatment. Inaccurate diagnosis may delay treatment or result in incorrect, ineffective treatment or unnecessary tests, which can prove costly and invasive. Inexperience with a difficult diagnostic procedure can affect the accuracy of the results. For example, a study of colposcopy, a test used to follow up on abnormal Pap smear results, showed that physicians who performed 100 or more colposcopies annually had more accurate findings than those who performed the procedure less often (Gordon, 1996).

Misdiagnosis is a major factor contributing to delays in treatment, according to JCAHO (2002). Hospital emergency departments accounted for just over one-half of all sentinel event cases of patient death or permanent injury due to delays in treatment. However, these serious events also happen in other healthcare settings, including intensive care units, medical-surgical units, inpatient psychiatric hospitals, the operating room, and in the home care setting. Of the 55 reported cases of delays in treatment, 52 resulted in patient death.

Medication Errors

Medication-related error is one of the most common types of error, and of primary concern to nurses who administer medications, as well as to the practitioner who prescribes medications, and the pharmacist who dispenses medications. Medication errors are called preventable adverse drug events (ADEs).

According to the U.S. Pharmacopeia (USP) (2000), the three most frequently reported types of medication errors were:

  • Omission errors (failure to administer an ordered medication dose).
  • Improper dose/quantity errors (any medication dose, strength or quantity that differs from that prescribed).
  • Unauthorized drug errors (the medication dispensed and/or administered was not authorized by the prescriber); this category includes dispensing or administering the wrong drug.

Other findings of the USP report included:

  • Of the five phases of the medication process, errors reported originated primarily in administering and documenting. (The other phases include ordering, dispensing, and monitoring.)
  • The primary contributing factors to medication errors were distractions and workload increases, many of which may result from efforts at cost containment.
  • Insulin, heparin and warfarin were the medications most often associated with errors.
  • In 32% of the records where documented action was taken due to a medication error, the personnel involved with initiating or perpetuating the error were reportedly not informed of their involvement in the medication error event.

One study funded by AHRQ in two tertiary care hospitals (Bates, et al, 1995) found that errors in ordering medications accounted for 56 percent of preventable ADEs, while errors in administering medication accounted for 34 percent of preventable ADEs. A second study (Leape, 1995) showed that dosage errors, in particular, were primarily due to the physician's lack of knowledge about the drug or about the patient for whom it was prescribed.

A later study attempting to identify risk factors for preventable ADEs among patients admitted to medical and surgical units at two large hospitals (Bates, et al, 1999), found few such factors, suggesting that focusing on improving medication systems would prove more effective.

Even though nurses do not write the prescription or dispense the drug from the pharmacy, they are in a position to identify potential errors in prescribing and dispensing and thereby protect the patient. Nurses administering medication should observe the following six "rights:"

  • Right patient
  • Right drug
  • Right dose
  • Right dosage form
  • Right route
  • Right time

In 1999, The National Patient Safety Partnership, a coalition of healthcare organizations, released a list of 16 best practices in medication safety. (Box 1) If hospitals implemented all of these practices, it could markedly reduce medication errors.

Box 1: Best Practices for Medication Safety

  • To reduce the occurrence of adverse drug events (events that can cause, or lead to, inappropriate medication use and patient harm),
  • Patients can:
  • Tell physicians about all medications they are taking and responses/reactions to them
  • Ask for information in terms they understand before accepting medications
  • Providing Organizations and Practitioners can:
  • Educate patients
  • Put allergies and medications on patient records
  • Stress dose adjustment in children and older persons
  • Limit access to high hazard drugs
  • Use protocols for high hazard drugs
  • Computerize drug order entry
  • Use pharmacy-based IV and drug mixing programs
  • Avoid abbreviations
  • Use "unit dose" drug systems (packaged and labeled in standard patient doses)
  • Use "unit dose" drug systems (packaged and labeled in standard patient doses)
  • Purchasers can:
  • Require machine-readable labeling (barcoding)
  • Buy drugs with prominent display on name, strength, warnings
  • Buy "unit of use" packaging ("unit dose")
  • Buy IV solutions with two sided labeling
  • To reduce the potential for taking a medication that was not prescribed for them or cannot be safely taken by them, patients should ask the following five sets of questions before accepting prescription drugs.
  • Is this the drug my doctor (or other health care provider) ordered? What is the trade and generic name of the medication?
  • What is the drug for? What is it supposed to do?
  • How and when am I supposed to take it and for how long?
  • What are the likely side effects? What do I do if they occur?
  • Is this medication safe to take with other over-the-counter or prescription medications, or dietary supplements, that I am already taking? What food, drink, activities, dietary supplements or other medication should be avoided while taking this medication?
  • National Patient Safety Partnership, May 12, 1999

System Failures

Analysis of medical errors continues to show that human fallibility is only part of the picture; system failures are also guilty. A major study (Leape et al, 1995) showed that failures at the system level - in disseminating pharmaceutical information, in checking drug dosages and patient identities, and in making patient information available - were the real culprits in more than 75 percent of adverse drug events.

Cost containment is a system-level factor that can affect medical errors. For example, inadequate staffing levels of nurses increased the incidence of postoperative adverse events, such as urinary tract infections, pneumonia, thrombosis, and pulmonary compromise (Kovner and Gergen, 1998).

Research on system failures that have led to major industrial disasters (Peterson, 1996) found that the systems had nine characteristics in common:

  • Diffuse responsibilities
  • Underestimation of the severity of risks
  • Belief that compliance with the rules was sufficient to achieve safety
  • Lack of ability for team members to speak up
  • Failure to share and implement lessons learned in other facilities
  • Subordination of safety to other performance goals
  • Persistence of flawed design features
  • Failure to use risk management techniques
  • Poorly defined responsibility for safety within the organization
  • Healthcare systems with these characteristics create an unsafe environment for both patients and staff.

Factors and Situations that Increase the Risk of Errors

As the IOM acknowledges, "to err is human." However, research has shown that certain factors can increase the error rate (Reason, 1990), such as:

  • Fatigue - Working a double shift, for example, can increase the likelihood of errors. Medical residents on call for 36 hours or more are also at high risk for errors.
  • Alcohol and/or other drugs - Use of alcohol and/or drugs is incompatible with competent, professional safe patient care. Unfortunately, the combination of high stress and easy access to medications has led to substance abuse by physicians, nurses, and other health professionals.
  • Illness - Coming to work when you aren't well jeopardizes your health and the health and safety of patients.
  • Inattention/Distraction - A noisy, busy emergency department can make it difficult to concentrate on one patient's care, especially if you know that other patients are waiting to see you.
  • Emotional states - Anger, anxiety, fear and boredom can all impair job performance and lead to errors. A heavy workload, conflict with other staff or with patients, and other sources of stress increase the likelihood of errors.
  • Unfamiliar situations or problems - Nurses who "float" from one hospital department to another may not have the expertise needed for all situations.
  • Equipment design flaws - Here again, training and experience with equipment are key to avoiding errors.
  • Inadequate labeling or instructions on medication or equipment - Look-alike or sound-alike drugs can lead to errors. Incomplete or confusing instructions on equipment can result in inappropriate use.
  • Communication problems - Lack of clear communication among staff or between providers and patients is one of the most common reasons for error.
  • Hard-to-read handwriting - Doctors' handwriting has long been criticized for its illegibility, particularly on prescriptions. Fortunately, computerized medication ordering has eliminated this problem in many healthcare organizations.
  • Unsafe working conditions - Poor lighting and/or slippery floors can lead to errors, especially falls, a costly hazard in every hospital.

Focusing on the multi-causal nature of errors does not alter the role of individual accountability for safe practice. In fact, the National Council of State Boards of Nursing has testified as follows:

"Both systems liability for mistakes and individual accountability are important to protect the public. Absent individual accountability standards, practitioners who leave organizations after serious errors occur and are employed elsewhere will never receive necessary remediation or education to address human factors, thus compromising the safety of the patient." (Ridenour, 2000)

Populations of Special Vulnerability

The safety of all patients is of paramount concern for all care providers. However, some patients - for example, the very young and the very old - are particularly vulnerable to the effects of medical errors, often due to their inability to participate actively as a member of the health care team, most commonly related to communication issues. Nurses and other care providers need to recognize the special needs of these patients and act accordingly.

Older Patients

The normal aging process commonly includes some degree of impairment in vision and hearing. Older people may also suffer varying degrees of cognitive impairment. Alone or in combination, these problems contribute to difficulties in communication between patients and care providers. Serious illness, accidents or trauma, such as surgery, that require hospitalization, add another layer of anxiety and possible confusion that can further interfere with communication between patients and care providers, potentially leading to errors.

Older patients are at special risk for medication errors, which can have life-threatening or even fatal effects, due to the declining ability of the aging body to metabolize drugs. Visual, hearing or cognitive problems may lead to misunderstanding of instructions or failure to question an incorrect or unfamiliar drug. When caring for older patients, communication with a responsible family member or other patient advocate is essential.

Older patients are also at high risk of falling. Reasons include medication effects, existing health problems such as arthritis, confusion or other cognitive deficit, or postural hypotension. Many older people need to use the bathroom during the night and need assistance to avoid falls.

Infants and Children

The younger the patient, the greater the risk of serious medication errors with devastating effects. Weight-based dosing is required for almost all pediatric drugs, and pharmacists often must dilute stock solutions.

One research study in two urban teaching hospitals found that errors occurred in 5.7 percent of medication orders during the care of 1,120 pediatric patients admitted during 1999 (Kaushal, et al, 2001). In addition, the rate of potential adverse drug events - close calls/near misses - was three times the rate of potential ADEs found in a similar study of hospitalized adults.

The researchers noted that physicians at both hospitals handwrote medication orders, copies of which were sent to the pharmacy. According to the researchers, computerized medication order entry and decision support (with automatic checks on patient drug allergies, drug dosage, and drug-drug interaction) could have prevented 93 percent of potential ADEs, as could the participation of ward-based clinical pharmacists in ward rounds. Nearly 80 percent of potential ADEs occurred in drug ordering, and 34 percent involved incorrect dosing.

Infants and young children do not have the communication abilities needed to alert clinicians about potential drug errors or adverse effects that they experience. Infants, particularly newborns, are physiologically ill equipped to deal with drug errors. Parents of infants and children need to be fully informed and involved in their child's care during hospitalization and must be educated to question caregivers about medications and procedures.

Persons with Limited English Language Skills and/or Limited Literacy

Meeting the healthcare needs of Florida's culturally and ethnically diverse population may require bilingual care providers, translators or interpreters, or other communication experts. Without these experts available, communication of vital information between patient and provider can lead to misunderstanding and errors.

Many hospitals have translators or interpreters available for non-English speaking patients. If translation assistance is not available, communicating with a family member or other support person is essential. It is important to keep your words simple and concrete, and to use pictures or diagrams to explain procedures.

General guidelines to assist nurses caring for patients from 23 different cultural groups can be found in Culture and Nursing Care: A Pocket Guide (Lipson, Dibble, and Minarik, 1996). Each chapter outlines issues related to health and illness, symptom expression, self-care, birth, death, religion, family participation in care, and other topics.

When caring for patients whose verbal abilities are limited either by education, development, or neurological impairment, assistive devices such as an alphabet board, a picture board or magic slate may prove helpful. Patients who are unable to speak because of a tracheostomy or other surgical procedure should also have these devices available along with pencil and paper (Adkins, 1991).

Fall Risk

Falls are a commonly reported sentinel event and can be fatal. Older patients are not the only population at risk. Any patient who has had excessive blood loss may experience postural hypotension, increasing the risk of falling. Maternity patients or other patients who have epidural anesthesia are at risk for falls due to decreased lower body sensation. Factors that increase the risk of falls are summarized in Box 2.

Box 2: Risk Factors for Falls

  • Age 65 or over
  • History of falling
  • Impaired mobility or difficulty walking
  • Need for assistance in getting out of bed or transferring to and from a chair
  • History of dizziness or seizures
  • Impaired vision, hearing, or speech
  • Need for mobility assistive devices (cane, walker, wheelchair, crutches or braces)
  • Weakness or fatigue
  • Confusion, disorientation, impaired cognitive function
  • Use of medications such as diuretics, laxatives, or consciousness-altering drugs, including sedatives, analgesics, hypnotics, anti-depressants, tranquilizers.

Reporting Errors

Improving patient safety begins with prompt reporting of errors followed by analysis of the root causes and contributing factors and developing a plan of action to prevent similar errors in the future. Only in this way can a health care organization assess the safety of care delivered and whether safety is improving.

The mistaken attitude in healthcare that errors are solely the fault of individual practitioners has proved a major barrier to reporting. Instead of analyzing the multiple factors that contribute to errors, efforts have focused almost entirely on making providers more careful, reinforced by fear of punishment when they fail. Until the mid-1990s, this punitive attitude severely limited the reporting of errors. In fact, research shows that when the fear of punishment is removed, reporting of errors increases by as much as 10 to 20 fold (Leape, 2000).

Joint Commission on Accreditation of Healthcare Organizations

Each accredited healthcare organization must have two systems in place for reporting errors: an internal system and an external system. The Joint

Joint Commission on Accreditation of Healthcare Organizations, whose mission is "to continuously improve the safety and quality of care provided to the public," requires that healthcare organizations:

  • Have a process in place to recognize sentinel events;
  • Conduct thorough and credible root cause analyses that focus on process and system factors, not on individual blame;
  • Document a risk-reduction strategy and internal corrective action plan within 45 days of the organization becoming aware of the sentinel event.

JCAHO defines a sentinel event as any unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Including the words "or the risk thereof" broadens the definition to include potential sentinel events (close calls/near misses). In other words, if similar circumstances recurred, a serious adverse outcome would be likely. Reportable JCAHO sentinel events are summarized in Box 3.

Unanticipated death or major permanent loss of function, unrelated to the natural course of the patient's illness or underlying condition, or one of the following:

Box 3: JCAHO Reportable Sentinel Events

  • Suicides
  • Infant abduction or discharge to the wrong family
  • Rape
  • Transfusion reaction
  • Surgery on the wrong body part

Accredited facilities are to report not only actual sentinel events but potential sentinel events, the close calls/near misses that afford valuable learning opportunities for prevention of future errors. JCAHO also encourages facilities to submit the findings of their root cause analyses and corrective action plans. This information can be included in JCAHO's review of sentinel events, helping track national trends and develop strategies for improving patient safety.

Since 1995, JCAHO has reviewed 1,609 sentinel events. Of these, the most common are patient suicide (16.7percent), operative/postoperative complications (12.2 percent), medication errors (11.4 percent), and wrong-site surgery (11.3 percent).

JCAHO published an online newsletter, Sentinel Event Alert, which identifies specific sentinel events, describes their common underlying causes and suggests actions to prevent these occurrences. Accredited organizations are expected to:

  • Review and consider relevant information, if appropriate to the organization's services, from each Sentinel Event Alert.
  • Consider information in an alert when designing or redesigning relevant processes.
  • Evaluate systems in light of information in an alert.
  • Consider standard-specific concerns.
  • Implement relevant suggestions or reasonable alternatives or provide a reasonable explanation for not implementing relevant changes

Florida Law

Reporting sentinel events to JCAHO is voluntary. However, Florida law makes such reporting mandatory. Florida's Comprehensive Medical Malpractice Reform Act of 1985 (F.S.395.0197) mandates that each licensed hospital implement a risk-management program with state oversight and an internal incident-reporting system. State oversight is provided by the Florida Agency for Health Care Administration (AHCA). Each licensed facility is required to hire a risk manager, licensed under F.S. 395-10974, who is responsible for implementation and oversight of the risk management program.

Statute 395.0197 mandates internal reporting of any adverse incident (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:

(a) Results in one of the following injuries:

  • Death;
  • Brain or spinal damage;
  • Permanent disfigurement;
  • Fracture or dislocation of bones or joints;
  • A resulting limitation of neurological, physical, or sensory function which continues after discharge from the facility;
  • Any condition that required specialized medical attention or surgical intervention resulting from non-emergency medical intervention, other than an emergency medical condition, to which the patient has not given his or her informed consent; or
  • 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;

(b) Was the performance of a surgical procedure on the wrong patient, a wrong surgical procedure, a wrong-side surgical procedure, or a surgical procedure otherwise unrelated to the patient's diagnosis or medical condition;

(c) Required 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; or

(d) Was a procedure to remove unplanned foreign objects remaining from a surgical procedure."

The risk-management reporting system must:

  • Investigate and analyze the frequency and causes of adverse incidents to patients
  • Educate facility staff and agents
  • Analyze patient grievances related to patient care

All incident reports must be filed with the risk manager of the healthcare organization or his or her designee within 3 days after the event occurred. Following receipt of the report, the risk manager in turn must report the event to the Florida Agency for Health Care Administration (AHCA). Certain adverse incidents (sentinel events), referred to as Code 24 events, must be reported to AHCA within 24 hours of the occurrence (See Box 4).

Box 4: Code 24 Sentinel Events

Report to AHCA within 24 hours of occurrence:

  • Death of a patient
  • Brain or spinal damage to a patient
  • Performance of a surgical procedure on the wrong patient
  • Performance of a wrong-site surgical procedure
  • Performance of a wrong surgical procedure

In addition to their internal reporting system, Florida hospitals and ambulatory surgical centers also must submit to the Florida Agency for Health Care Administration (ACHA) an annual report of all adverse incidents and malpractice actions (new, pending, and closed). They are also required to report any injuries of which they are aware that occur through any health care service, including nursing homes, home health organizations, doctors' offices, dentists' offices, or any other purveyor of health care service. Florida Statute 641.55 requires similar reporting of patient injury incidents by HMOs.

Three types of reports are required by ACHA:

  • The Annual Report, which includes all adverse incidents that occur in the facility in the course of a calendar year. These reports are due after the first of each year for the previous year.
  • 24-Hour Urgent Issue Report, a preliminary report of serious patient injuries of a more complicated nature, within 24 hours of the occurrence of the injury. (See Box 4)
  • Code 15 Reports, which report in detail on each serious patient injury, the facility's investigation of the injury, and whether the factors causing or resulting in the adverse incident represent a potential risk to other patients. The findings of that investigation must be reported to AHCA within 15 days of an adverse incident. Failure to comply with this mandate may result in fines of as much as $25,000.

Moving Beyond Blame: Improving Patient Outcomes

"The medical imperative is clear: to make health care safe we need to redesign our systems to make errors difficult to commit, and create a culture in which the existence of risk is acknowledged and injury prevention is recognized as everyone's responsibility." (Leape et al, 1998)

Root Cause Analysis (RCA)

JCAHO requires that a thorough, credible root cause analysis (RCA) be performed for each reported sentinel event. The goal of a Root Cause Analysis is to find out:

  • What happened
  • Why did it happen
  • What do you do to prevent it from happening again

VA National Center for Patient Safety

Root Cause Analysis (RCA) is a tool for identifying error prevention strategies. It is a process for discovering basic and contributing causes of error with the continuing goal of preventing recurrence.

RCA is an interdisciplinary process involving:

  • Experts from all services involved
  • Those who are the most familiar with the situation
  • Asking why at each level of cause and effect
  • Identification of changes needed
  • As great a degree of impartiality as possibility

According to the VA National Center for Patient Safety (2002), a thorough RCA must include:

  • Determination of human and other factors
  • Determination of related processes and systems
  • Analysis of underlying cause and effect systems through a series of WHY questions
  • Identification of risks and their potential contributions*
  • Determination of potential improvement in processes or systems

One step in the RCA of both actual adverse events and close calls is determining the Safety Assessment Code (SAC) score of the event. The Severity and Probability Categories and the SAC Matrix are shown in Figure 3. (VHA Handbook 1050.1, Appendix D-1 and D-2).

A credible RCA must:

  • Include participation by the leadership of the organization and those most closely involved in the processes and systems.
  • Be internally consistent.
  • Include consideration of relevant literature.

In July 2001, the Agency for Healthcare Research and Quality released a report outlining evidenced-based clinical recommendations for improving patient safety. Titled "Making Health Care Safer: A Critical Analysis of Patient Safety Practices," the report reviews 79 practices to prevent adverse events and improve patient safety, based on current research. The 11 most highly rated practices are listed in Box 5. The authors of this report emphasized that this list should not be considered complete, and that it was weighted toward care of the very ill, rather than the mildly or chronically ill. Other measures to improve patient safety are summarized in Box 1.

Box 5 - Clinical Opportunities for Safety Improvement

  1. Appropriate use of prophylaxis to prevent venous thromboembolism in patients at risk.
  2. Use of perioperative beta-blockers in appropriate patients to prevent perioperative morbidity and mortality.
  3. Use of maximum sterile barriers while placing central intravenous catheters to prevent infections.
  4. Appropriate use of antibiotic prophylaxis in surgical patients to prevent perioperative infections.
  5. Asking that patients recall and restate what they have been told during the informed consent process.
  6. Continuous aspiration of subglottic secretions (CASS) to prevent ventilator-associated pneumonia.
  7. Use of pressure relieving bedding materials to prevent pressure ulcers.
  8. Use of real-time ultrasound guidance during central line insertion to prevent complications.
  9. Patient self-management for warfarin (Coumadin™) to achieve appropriate outpatient anticoagulation and prevent complications.
  10. Appropriate provision of nutrition, with a particular emphasis on early enteral nutrition in critically ill and surgical patients.
  11. Use of antibiotic-impregnated central venous catheters to prevent catheter-related infections.

In July 2002, The Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) issued new mandatory goals and recommendations to improve patient safety, to take effect in January 2003. Hospitals and other organizations will be evaluated by accreditation representatives to see whether these recommendations or acceptable alternative measures are being implemented. Failure to implement the recommendations could result in loss of accreditation and federal funding. The 2003 National Patient Safety Goals and Recommendations are summarized in Box 6.

Box 6. 2003 National Patient Safety Goals and Recommendations

  • Goal 1. Improve the accuracy of patient identification.
  • Recommendations:
  • Use at least two patient identifiers (neither of which is the patient's room number) whenever taking blood samples or administering medications or blood products.
  • Prior to the start of any surgical or invasive procedure, conduct a final verification process, such as a "time out," to confirm the correct patient, procedure, and site, using active - not passive - communication techniques
  • Goal 2. Improve the effectiveness of communication among caregivers.
  • Recommendations:
  • Implement a process for taking verbal or telephone orders that requires a verification "read-back" of the complete order by the person receiving the order.
  • Standardize the abbreviations, acronyms and symbols used throughout the organization, including a list of abbreviations, acronyms and symbols not to use.
  • Goal 3. Improve the safety of using high-alert medications.
  • Recommendations:
  • Remove concentrated electrolytes (including, but not limited to, potassium chloride, potassium phosphate, sodium chloride >.9%) from patient care units.
  • Standardize and lmit the number of drug concentrations available in the organization.
  • Goal 4. Eliminate wrong-site, wrong-patient and wrong-procedure surgery.
  • Recommendations:
  • Create and use a preoperative verification process, such as a checklist, to confirm that appropriate documents (e.g., medical records, imaging studies) are available.
  • Implement a process to mark the surgical site and involve the patient in the marking process.
  • Goal 5. Improve the safety of using infusion pumps.
  • Recommendations:
  • Ensure-free-flow protection on all general-use and PCA intravenous infusion pumps used in the organization.
  • Goal 6. Improve the effectiveness of clinical alarm systems.
  • Recommendations:
  • Implement regular preventive maintenance and testing of alarm systems.
  • Assure that alarms are activated with appropriate settings and are sufficiently audible with respect to distances and competing noise within the unit.

A National Problem of Epidemic Proportion

It is clear that, although the United States provides some of the best health care in the world, the numbers of errors in health care are at unacceptably high levels. The Institute of Medicine’s report estimates that more than half of the adverse medical events occurring each year are due to preventable medical errors, causing the death of tens of thousands. The cost associated with these errors in lost income, disability, and health care costs is as much as $29 billion annually. The consequences of medical mistakes are often more severe than the consequences of mistakes in other industries—leading to death or disability rather than inconvenience on the part of consumers—underscoring the need for aggressive action in this area.

A wide body of research, including many studies funded by AHRQ, supports the IOM conclusions. The two seminal studies on medical error) have shown that adverse events occur to approximately 3–4 percent of patients. In another study the average intensive care unit (ICU) patient experienced almost two errors per day. This translates to a level of proficiency of approximately 99 percent. One out of five of these errors were potentially serious or fatal. If performance levels of 99.9 percent—substantially better than those found in the ICU—applied to the airline and banking industries, it would equate to two dangerous landings per day at O'Hare International Airport and 32,000 checks deducted from the wrong account per hour .

Many of these adverse events are associated with the use of pharmaceuticals, and are potentially preventable. The IOM estimates the number of lives lost to preventable medication errors alone represents over 7,000 deaths annually—more than the number of Americans injured in the workplace each year. In addition, preventable medication errors are estimated to increase hospital costs by about $2 billion nationwide. A 1995 study estimated that problems related to the use of pharmaceutical drugs account for nearly 10 percent of all hospital admissions, and significantly contribute to increased morbidity and mortality in the United States. A 1991 study of hospitals in New York State indicated that drug complications represent 19 percent of all adverse events, and that 45 percent of these adverse events were caused by medical errors. In this study, 30 percent of the individuals with drug-related injuries died

In early 1997, the President established the Advisory Commission on Consumer Protection and Quality in the Health Care Industry (Quality Commission) and appointed Health and Human Services Secretary Shalala and Labor Secretary Herman as co-chairs. The Quality Commission released two seminal reports focusing on patient protections and quality improvement. Subsequent to the Commission’s second report on patient safety and quality improvement and consistent with its recommendations, the President established the Quality Interagency Coordination Task Force (QuIC), a umbrella organization also co-chaired by Secretary Shalala and Secretary Herman, to coordinate Administration efforts to improve quality. As he established the QuIC, the President stated that "For all of its strengths, our health care system still is plagued by avoidable errors."

Also consistent with the Quality Commission’s recommendations, Vice President Gore launched the National Forum for Health Care Quality Measurement and Reporting. Known as the Quality Forum, it is a broad-based, widely representative private body that establishes standard quality measurement tools to help all purchasers, providers, and consumers of health care better evaluate and ensure the delivery of quality services. In addition to the work and significant potential of the QuIC and Quality Forum, other Federal agencies have made significant efforts to reduce medical errors and increase attention on patient safety.

In accordance with its recent reauthorization, the AHRQ is the lead agency for the Federal government on quality in health care. It sponsors research examining the frequency and cause of medical errors and tests techniques designed to reduce these mistakes. It also examines issues generally related to health care quality, including overuse and underuse of services.

The Department of Defense (DoD) and the Department of Veterans Affairs (VA), serving over 11 million patients nationwide, have begun to implement computerized physician order entry systems, proven effective in reducing medical errors. In addition, Veterans Affairs has implemented a computerized medical record in all their 172 hospitals, making it possible to reduce errors by providing complete information about patients at the point of care. Over the past 3 years, the VA created an error reporting system, established four Centers of Inquiry for Patient Safety, and began to use barcode technology to reduce medication errors.

The Health Care Financing Administration (HCFA), through its Peer Review Organizations (PROs), is working to reduce errors of omission for the 39 million Medicare beneficiaries. Under their current performance-based contracts, the PROs are working to prevent failures and delays in delivering services for breast cancer, diabetes, heart attack, heart failure, pneumonia, and stroke. These efforts have already decreased mortality for heart attack victims.

The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) collect data on adverse events that are the result of treatment, such as hospital-acquired infections and the unintended effects of drugs and medical devices. CDC's National Nosocomial Infections Surveillance (NNIS) system is a hospital-based reporting system that monitors hospital-acquired infections that afflict more than two million patients every year. Among participating hospitals, bloodstream infection rates have decreased by more than 30 percent since 1990, and wound infections following surgery have decreased by 60 percent among high-risk patients. FDA receives approximately 100,000 reports per year of adverse events associated with medical devices and over 250,000 reports associated with pharmaceuticals. FDA estimates that over one-third of the adverse events associated with medical devices and pharmaceuticals are preventable.

In all of these efforts, the Administration has worked closely with the private sector and the States. Many States and members of the private sector are moving ahead with actions to reduce the number of medical errors. Currently, almost 20 States have implemented mandatory reporting systems to improve patient safety and hold health care organizations responsible for the quality of care they provide. The private sector has also taken large strides to address the issue of patient safety, most recently with the creation of the Leapfrog Group by executives of some of the Nation’s biggest companies, including General Motors and General Electric. This group encourages all employers to make safe medicine a top priority of the health insurance they provide and to steer workers to the hospitals that make the fewest mistakes.

While both the public and private sectors have made notable contributions to reducing preventable medical errors, additional and aggressive efforts are needed in and outside of the Federal government to further reduce these mistakes.

Institute of Medicine Recommendations

The IOM report recommends the establishment of a national goal of reducing the number of medical errors by 50 percent over 5 years. To that end, it outlined a four-tiered approach to reduce medical mistakes nationwide, including actions to:

  • Establish a national focus to create leadership, research, tools, and protocols to enhance the knowledge base about safety.
  • Identify and learn from medical errors through both mandatory and voluntary reporting systems.
  • Raise standards and expectations for improvements in safety through the actions of oversight organizations, group purchasers, and professional groups.
  • Implement safe practices at the delivery level.

A Road Map for Action: The Federal Response

The QuIC agencies join the IOM’s call for action to reduce errors, implement a system of public accountability, develop a robust knowledge base about medical errors, and change the culture in health care organizations to promote the recognition of errors and improvement in patient safety. This report describes the actions that the QuIC agencies will take to build on current programs and develop new initiatives to reduce errors.

The QuIC fully endorses the IOM’s goal of reducing the number of medical mistakes by 50 percent over 5 years and has developed a strategy that builds on the IOM recommendations and, in some cases, goes beyond them. This strategy is detailed below.

Creating a National Focus to Enhance the Knowledge Base on Patient Safety

IOM Recommendation: Creating a Center for Patient Safety. The IOM recommends that Congress fund a Center for Patient Safety within the Agency for Healthcare Research and Quality (AHRQ) that will set national goals for patient safety, track progress in meeting these goals, and issue an annual report to the President and Congress on patient safety. The Center should also enhance the current knowledge base on patient safety by developing a research agenda, disseminating grants for research on patient safety, funding Centers of Excellence, evaluating methods for identifying and preventing errors, and funding dissemination and communication activities to improve patient safety.

QuIC Response. The Administration endorses the IOM recommendation and the President has included $20 million in the Fiscal Year (FY) 2001 budget to support a Center for Quality Improvement and Patient Safety at the AHRQ, as part of the Agency’s broader quality agenda. The Center will fund research on medical errors, principally through extramural grants and contracts. It will work with private-sector entities and public sector partners, including the Quality Forum, to develop national goals for patient safety; issue an annual report on the state of patient safety nationally; promote the translation of research findings into improved practices and policies; and educate patients, consumers, and health care providers about patient safety.

IOM Recommendation: Establishing reporting systems nationwide. The IOM recommends that the Administration and the Congress move to establish a nationwide system of error reporting that includes both mandatory and voluntary components.

Mandatory Reporting Systems. The IOM recommends the development of a nationwide mandatory reporting system to provide for the collection of standardized information by state governments about adverse events that result in death or serious harm. The report states that adverse event reporting should initially be required of hospitals and eventually be required of other institutional and ambulatory care delivery systems. It recommends that this system should be implemented nationwide, linked to systems of accountability, and made available to the public. The IOM concludes that if States choose not to implement the mandatory reporting system, the Department of Health and Human Services (DHHS) should serve as the responsible entity.

Voluntary Reporting Systems. The IOM report does not propose the establishment of a national voluntary reporting system; rather, it offers a variety of options for more limited voluntary reporting systems that function in all 50 States and build on currently existing options, including the development of systems focused on selected areas, such as medications, surgery, and pediatrics or using a sampling technique to collect the full range of information from a limited subset of health care providers. The IOM recommends that more research be conducted to determine the best way to develop voluntary reporting systems that complement proposed mandatory reporting systems and can identify potential precursors to errors, thus preventing patient harm. It also recommends that the Congress extend peer review protections to data related to patient safety and quality improvement collected through voluntary reporting systems.

QuIC response. The Administration agrees with the IOM that error reporting systems should be established in all 50 States, and that these systems should have both mandatory and voluntary components. Such an effort should establish important complementary approaches to both learning and accountability on errors. Well-designed patient safety programs include reporting systems that both hold health systems accountable for delivering high quality health care and provide important information to health care decision-makers that improves patient safety.

The QuIC agrees with the IOM that individuals should have access to information leading up to and including the occurrence of a preventable error that caused their serious injury or the death of a family member. However, we believe that subsequent "root-cause" analyses undertaken to determine the internal shortcomings of the hospital’s delivery system should not be subject to discovery in litigation and that appropriate legislation should be enacted in conjunction with or prior to the implementation of mandatory or voluntary reporting systems.

It is important to note that the QuIC believes that any legislation or administrative intervention in this area should not undermine individuals’ rights to redress for criminal activity, malpractice, or negligence. The QuIC does not support legislation that would allow safety reporting systems to serve as a shield for providers engaging in illegal or negligent behavior.

Mandatory Reporting Systems. The QuIC supports the development of State-based systems to require the collection of standardized information on preventable, adverse events that result in death or serious harm, and believes that the development of these systems are ultimately in the best interests of patients. We agree with the IOM that the scope of events targeted by mandatory reporting systems that contain public disclosure components should be limited to serious, preventable, and identifiable adverse events. By limiting required reporting systems to the most serious of errors—those causing life-long disability or death—this approach will most effectively target egregious problems and minimize the cost of operating such a system. The QuIC believes that, once mandatory systems are fully implemented, such information for each health system should be consolidated and made public, but that there should be no identification of patients or individual health care professionals. The QuIC believes that mandatory reporting systems that contain public disclosure components should not be used as a tool for punitive action by State and local authorities, but should be used as a mechanism to provide the public with information about the safety of its health systems and to highlight errors that can and should be prevented.

The IOM has a set of specific recommendations for the structure of a nationwide mandatory reporting system. The QuIC believes that there are a number of issues that need to be addressed prior to determining the best mechanism to ensure the establishment of State-based mandatory reporting systems. The Administration will work with the Congress to outline the appropriate Federal role in such a system. However, while these issues are being resolved, the Administration will take the following actions to demonstrate the importance of implementing mandatory reporting systems and to create an environment in which there is more widespread support for their use.

  • Implement a mandatory reporting system in the over 500 hospitals and clinics operated by the Department of Defense. Beginning this spring, the Department of Defense will implement a new reporting system in its 500 hospitals and clinics serving approximately 8 million patients. This confidential reporting system will be modeled on the system in operation at the Department of Veterans Affairs and will be used to provide health care professionals and facilities with the information necessary to protect patient safety. This system will begin to be pilot tested in August of 2000, will collect information on adverse events, medication errors, close calls, and other patient safety issues. DoD providers will inform affected patients or their families when serious medical errors occur.
  • Expand mandatory reporting requirements for blood banks and establishments that deal with blood products nationwide. By the end of the year, the Food and Drug Administration (FDA) will release regulations to improve the safety of blood transfusions by requiring the over 3,000 blood banks and establishments dealing with blood products to report errors and accidents, such as mistyping blood products and adverse events affecting donors, that affect patient safety. Currently, only 400 blood banks are required to report such errors.

In addition to Federal action to integrate mandatory reporting systems into Federal agencies delivering care and strengthen the mandatory systems that currently exist, there is a critical need for Federal leadership in the development of patient safety standards. To that end, the Federal government will:

  • Identify a set of patient safety measurements critical to the identification of medical errors. The QuIC will ask the Quality Forum to identify a set of patient safety measurements that should be a basic component of any medical errors reporting system. Developing standardized measures lays the foundation for a uniform system of data collection and facilitates the development of these systems.
  • Identify a set of patient safety practices critical to prevention of medical errors. The QuIC will ask the Quality Forum to identify, within 12 months, patient safety practices that should be adopted by all hospitals and health systems, and will undertake activities to encourage their widespread use. The QuIC suggests that mandatory reporting systems include information on whether hospitals and health systems' adopt these patient safety practices.
  • Identify issues related to the implementation of mandatory reporting for error reduction. Using the Quality Forum’s recommendations for medical error reporting, HCFA will develop a pilot project, through the PRO program, for up to 100 hospitals that volunteer to implement penalty-free, confidential, mandatory reporting systems. These pilot projects will assist hospitals in changing their medical delivery systems to reduce or eliminate errors. This pilot project will include a rigorous evaluation component and identify issues related to the implementation of medical error reporting systems.
  • Determine the most effective way to present information on the incidence of medical errors to the public. HCFA, OPM, and AHRQ will lead a QuIC effort to work with the Quality Forum and States that have mandatory reporting systems to determine how data on medical errors can be collected, validated, and presented to the general public and local policy officials—and to determine the impact of providing such information. Since informing the public about the safety of their health care systems is a critical component of mandatory reporting systems, this pilot project will provide insights on presenting this information to the public.
  • Examine existing mandatory reporting systems. The Center for Quality Improvement and Patient Safety, in collaboration with other QuIC agencies, will evaluate the effectiveness of currently existing mandatory reporting systems at the Federal and State levels and develop recommendations to improve them. This information will be presented to States and other organizations considering developing such systems or that currently have existing systems, to help them design effective reporting systems likely to improve patient safety.

The QuIC believes that these actions will encourage States to begin implementing their own mandatory reporting systems for preventable adverse events, with the goal that all 50 States have mandatory reporting systems for preventable adverse events within 3 years. This time frame will enable the Federal government, working with the Congress and other private-sector stakeholders, to conclusively resolve outstanding implementation issues. If all states have not implemented mandatory reporting systems within three years, the QuIC will deliver recommendations to the President that assure all health care institutions are reporting serious, preventable adverse events.

Although currently the QuIC believes that moving towards a mandatory reporting system is the appropriate course of action, if research conducted by AHRQ and other agencies indicates that the implementation of these systems does not enhance (or detracts from) patient safety, these results will be reported to the QuIC. Special emphasis will be placed on efforts to determine whether making information public serves to hold health systems accountable and reduce preventable errors, or whether it only stifles reporting.

Voluntary Reporting Systems. The QuIC agrees with the IOM that voluntary reporting systems are a critical component of a national strategy to reduce errors. Information from voluntary reporting systems is usually gathered by an independent entity and is used to identify patterns of errors. The QuIC proposes to integrate existing Federal voluntary reporting systems with data collection efforts by States and private organizations. The QuIC agrees with the IOM that these programs should be confidential to protect the privacy of patients, institutions, and providers reporting errors and close calls. Experience in other industries demonstrates that confidentiality encourages reporting. In order to encourage the development of voluntary reporting systems, the Administration will:

  • Implement a voluntary reporting system nationwide for veterans’ hospitals. The VA currently operates a mandatory reporting system. By the end of the year, the VA will implement a voluntary reporting system for both adverse events and close calls nationwide. Information will be collected by an independent external entity, analyzed, and disseminated to all VA health care networks to help prevent medical errors. Implementing this system is likely to lead to a richer database of information, as incidents are reported on a de-identified basis, and will allow researchers to compare the effectiveness of identified systems to de-identified ones.
  • Examine existing voluntary systems. The Center for Quality Improvement and Patient Safety, with its QuIC partners, will evaluate the effectiveness of existing voluntary reporting systems at the Federal and State levels and develop recommendations to improve them. This study will demonstrate which entity or entities would be best to collect, analyze, and disseminate information on frequently occurring errors and the best interventions to prevent them.

Setting Performance Standards and Expectations for Safety

IOM Recommendation: Include patient safety in performance standards and expectation for health care organizations. The IOM recommends that regulators and accreditors should require health care organizations to implement meaningful patient safety programs with defined executive responsibility. Public and private purchasers should provide incentives to health care organizations to demonstrate continuous improvement in patient safety.

QuIC response. The QuIC reviewed current Federal activities and proposed several ways to improve safety through current oversight activities. These include:

  • Assuring that all hospitals participating in the Medicare program implement patient safety programs. The Health Care Financing Administration intends to publish regulations this year requiring the over 6000 hospitals participating in the Medicare program to have ongoing medical error reduction programs that would include, among other interventions, mechanisms to reduce medication errors. To comply with this new regulation, most hospitals are likely to implement systems such as automated pharmacy order-entry systems and automatic safeguards against harmful drug interactions and other adverse events.
  • Requiring the almost 300 health plans in the Federal Employees Health Benefits Program to implement patient safety programs. In its annual call letter, to be issued this April, the Office of Personnel Management will announce that, beginning in 2001, all health plans participating in the program will be required to implement patient safety initiatives. OPM will encourage health plans to collaborate with their providers to reduce errors and improve the quality of care.
  • Working with private-sector employers and employees to incorporate patient safety into purchasing decisions. This year, the Department of Labor will include information on medical errors in the Health Benefits Education Campaign. This national effort educates employees about issues of quality and safety under their employer-provided health benefits so that they can make informed health benefits decisions and educates employers in order to facilitate the provision of high-quality, affordable health benefits to their employees.

IOM Recommendation: Performance standards and expectations for health professionals should focus greater attention on patient safety. Periodic re-examination and re-licensing of doctors, nurses, and other key providers should be conducted based on both competence and knowledge of safety practices. Professional societies should make a visible commitment to patient safety by establishing a permanent committee dedicated to safety improvement.

QuIC response. The QuIC is supportive of these goals, but recognizes and agrees with the IOM that they appropriately fall under State jurisdiction and oversight. However, the QuIC agencies will provide technical assistance to State or professional agencies seeking to ensure a basic level of knowledge for health care providers on patient safety issues, promote model patient safety programs that include evidence-based best patient safety practices to provider organizations, or help agencies encourage the cultural change necessary to make reporting systems a success.

IOM Recommendation: FDA should increase attention to the safe use of drugs. Both pre- and postmarketing processes should be improved to maximize safe drug use. FDA should develop and enforce standards for the design of drug packaging and labeling that will maximize safety in use and require pharmaceutical companies to test proposed drug names to identify potential sources of confusion with existing drug names. In addition, the Agency should work with physicians, pharmacists, consumers, and others to establish appropriate responses to problems identified through post-marketing surveillance activities.

QuIC response. The QuIC endorses the IOM recommendation. FDA currently has a strong program of pre- and post-market surveillance, and is pleased that the President is committing $33 million, an increase of 65 percent over last year’s funding level, in his FY 2001 budget to prevent medical errors associated with drugs and medical devices. Among other things, it would:

Initiate new efforts to ensure that pharmaceuticals are packaged and marketed in a manner that promotes patient safety. Within one year, FDA will develop new standards to help prevent medical errors caused by proprietary drug names that sound similar or packaging that looks similar, making it easy for health care providers to confuse medications. The Agency will also develop new label standards by the end of the year that highlight common drug-drug interactions and dosage errors related to medications.

  • The QuIC will ask the Quality Forum to define unambiguously, within 12 months, a set of egregious errors that are preventable and should never occur. These measures will serve as criteria for a HCFA-sponsored mandatory reporting demonstration project with a State that already has an existing mandatory reporting requirement. HCFA will publish the hospital rates for these events without patient identifiers.
  • HCFA and its QuIC partners will evaluate whether consumers found this information valuable and what they understood about it. Based on these results, HCFA will move towards a national mandatory reporting system, with publication of findings, for all hospitals participating in Medicare.
  • Federal agencies, in partnership with other organizations, will develop options for mandatory reporting systems that provide the public and purchasers with publicly available information about programs and procedures in place to reduce errors. This work will require the development of evidence-based, systems-level measures in collaboration with the Quality Forum.
  • OPM will require that health plans have error reduction plans and will report on its web site whether the health plans have reliable patient safety initiatives in place.
  • QuIC will ask the Quality Forum to identify, within 12 months, patient safety practices that institutions should undertake and urges that information about whether the measures are in place be made available to the public.
  • FDA will report to the public on the safety of drugs, devices, and biologic products.
  • QuIC proposes that State and Federal mandatory reporting systems, as well as those of private accrediting and other oversight groups, be evaluated to determine the ways in which they are helpful in assuring public accountability for patient safety, and that these results be used to develop future reporting systems.
  • AHRQ will include information on patient safety in the National Quality Report it is developing in collaboration with other agencies, in particular, the National Center for Health Statistics.
  • OPM will require that health plans describe their patient safety initiatives, will make patient safety information available in both print and electronic formats for the open enrollment period in Fall, 2000, and will expand its Web site to include information about programs designed to reduce errors and enhance patient safety.
  • OPM will encourage health plans to annotate Preferred Provider Organization (PPO) directories to indicate which hospitals and physicians’ offices use automated information systems.
  • FDA will improve the safety of transfusions by expanding mandatory reporting requirements for blood bank errors and accidents, so that they apply to all registered blood establishments.

Learning from Errors

  • The new Center for Quality Improvement and Patient Safety (CQuIPS) at AHRQ will identify existing State and Federal reporting systems (both mandatory and voluntary), evaluate their suitability in helping to build a national system of errors reporting, and evaluate how their data collection or enforcement efforts can be enhanced to improve the value of those systems.
  • QuIC will work with the Quality Forum to develop reporting criteria that assure that information can be pooled and shared as needed across organizations.
  • CQuIPS, working with the QuIC, will describe and disseminate information on characteristics of existing voluntary reporting programs associated with successful error reduction and patient safety improvement efforts. FDA, CDC, and NASA will provide expertise in the development of these nonpunitive systems.
  • Within six months, HCFA, working with a Peer Review Organization (PRO) program, will develop a pilot of a confidential, penalty-free learning system with several hospitals on a voluntary basis.
  • Federal agencies, including the FDA, VA, DoD, CDC, HCFA, and AHRQ, will integrate data from different sources and conduct and support analysis to identify error prone procedures, products, and systems.
  • By August 2000, the DoD will complete development of a patient safety improvement program based on a reporting system modeled on that of the VA.
  • VA will establish a voluntary reporting system to supplement its existing mandatory system.
  • AHRQ, in collaboration with other Federal agencies, will investigate, develop and test strategies to provide effective feedback to clinicians and institutions on methods for improving patient safety.
  • Federal agencies will assist health care providers to develop the skills necessary for analyzing adverse events and near misses (e.g., root cause analysis, trending, search tools). Federal agencies providing health care will develop internal systems to 1) identify and report errors to clinicians and other decision makers, and 2) learn from those errors and near misses to prevent future events.
  • Outreach to Stakeholders: QuIC will develop programs to foster the dissemination of research findings to end users through activities such as AHRQ’s User Liaison Program; provide support to the Quality Forum to increase the national discussion on errors, their reduction, and standardized measures of errors; and fund collaborative agreements with health care professional organizations that foster education, track patient safety initiatives, provide input to the new patient safety research centers, and translate, disseminate, and promote adoption of research findings.
  • Patient Safety Clearinghouse: AHRQ will develop a clearinghouse in partnership with other Federal agencies and private-sector organizations to provide an objective source of state-of-the art information on patient safety.
  • AHRQ will initiate a "National Morbidity & Mortality Conference" posting selected cases (stripped of identifying information) in a public forum via Internet technology, and establish a Web site where patients can report incidents that will be analyzed to identify emerging problems.

Peer Review Protections

  • The QuIC supports the extension of peer review protections to facilitate reporting of errors in a blame-free environment, and will propose considerations of confidentiality that will not undermine current mechanisms to address criminal activity or negligence.
  • As part the development of the national reporting system, appropriate electronic protections (i.e., firewalls and encryption) will be constructed to ensure that the confidentiality of the patients involved and the clinician or institution providing the information is maintained, and that the information gathered will not be used for punitive purposes. Experience with reporting systems in other industries demonstrates that this approach encourages reporting of errors.

Setting Performance Standards and Expectations for Safety

Raising the Standards for Health Care Organizations

  • HCFA will use its power as a purchaser and regulator to promote the use of effective error-reduction initiatives in the health care institutions with which it deals.
  • HCFA will publish regulations this year requiring hospitals participating in the Medicare Program to ongoing medical error reduction programs.
  • OPM will follow the lead of selected private purchasers to raise the standard for participation by requiring that all health plans with which it contracts seek accreditation from an independent, national accrediting organization that includes evaluation of patient safety and programs to reduce errors in health care.
  • In its call letter for the 2001 contract year, OPM will ask health plans to encourage their preferred hospitals to use automated prescription systems and other integrated data systems. OPM will encourage health plans to annotate PPO directories to indicate which hospitals and physicians’ offices use such automated programs.

Raising the Standards for Health Care Professionals

The QuIC will:

  • Develop and evaluate programs introducing health professionals to errors analysis and the challenges of practicing in a technically complex environment, explore the use and testing of simulators and automation as education tools, support training in errors research and evaluation, and develop patient safety expertise at the State level using the CDC’s Epidemic Intelligence Service as a model.
  • Convene a meeting of the accrediting, licensing, and certifying bodies of the health professions to review information on medical errors in the context of current practice requirements and propose methods of strengthening health professions’ education in the areas of medical error prevention and medical error evaluation as a means of improving patient safety.
  • Collaborate with the Federation of State Medical Boards and other entities to encourage that error reduction and prevention education be a provision for relicensing of health professionals.
  • Collaborate in the planning, implementation, and evaluation of a national summit addressing patient safety and medical error reduction programs, and in producing directives for the future.
  • Provide training within the QuIC agencies that provide care to encourage use of patient safety information and encourage enhanced reporting in partnership with private-sector accreditors, purchasers, and providers.
  • Provide technical assistance to State or professional agencies seeking to ensure a basic level of knowledge for health care providers on patient safety issues.

Safe Use of Drugs and Devices

Within 1 year, the FDA will initiate programs to:

  • Develop additional standards for proprietary drug names to avoid name confusion.
  • Develop standards for packaging to prevent dosing and drug mix-ups.
  • Develop new label standards for drugs, highlight drug–drug interactions, potential dosing errors, and address other common errors related to medications.
  • Implement the Phase II pilot study of the Congressionally mandated Medical Product Surveillance Network (MedSUN).
  • Intensify efforts to ensure manufacturers’ compliance with FDA programs, specifically naming, labeling, and packaging.
  • Provide access to databases linked to health care systems and other sources of adverse-event and marketing data, and link these to existing registries of product users.
  • Complete the on-line Adverse Event Reporting Systems (AERS) for drugs and biologics.
  • Strengthen FDA's analytical and investigative capacities.
  • Strengthen FDA outreach activities and collaboration with other Government agencies and stakeholders
  • Under the leadership of the CQuIPS, the QuIC will promote, at the executive level, the development and dissemination of evidence-based, best patient-safety practices to provider organizations.
  • QuIC participants, including HCFA, VA, DoD, AHRQ, CDC, and FDA, will explore opportunities with private-sector accreditation, purchaser, and provider organizations to develop organization-based, patient-safety models that could be evaluated, and if found effective, disseminated widely. In addition, these stakeholders will be engaged in a regular dialogue with QuIC participants to ensure that the stakeholders’organizational needs are being met through Federal research and reporting initiatives.
  • Through its exemplary patient safety program, VA will continue to scrutinize its care provision for opportunities to improve safety, and develop and expand its reporting system.
  • VA will invest $47.6 million this year to increase patient safety training for staff (select for details in .
  • DoD will invest $64 million in FY 2001 to begin implementation of a new computerized medical record system, including an automated order entry system for pharmaceuticals (details in ).
  • Other QuIC direct-care providers will initiate patient safety programs (e.g., HRSA’s community health care centers are investigating the most effective programs that can be implemented in their health care delivery systems).
  • QuIC member agencies will begin a collaborative project this summer with the Institute for Healthcare Improvement to reduce errors in high-hazard health care delivery settings.

Building Public Awareness of Medical Errors

  • Through the QuIC’s Enhancing Patient and Consumer Information Working Group, led by OPM and HCFA, Federal agencies will develop and coordinate an information campaign for their constituencies and beneficiaries to increase their awareness of the problem of medical errors and patient safety.
  • AHRQ will develop generic material for the public on preventing medical errors that Federal agencies can disseminate, reprint, or adapt. This material will enable patients to become more involved in their care and to be more active participants in the decisionmaking surrounding their care.
  • The CQuIPS will develop and test patient safety questions for inclusion in the patient survey now being developed for provider-level assessment of health care.
  • HCFA will conduct research aimed at shaping programs to educate beneficiaries about medical errors.
  • Within 1 year, FDA will increase collaborative programs with patient and consumer groups regarding patient safety.
  • FDA will enhance its interactions with the public through meetings with consumer and patient organizations, and through grass-roots informational meetings. The meetings will focus on patient needs and the safe use of medical products, particularly for home use. The meetings will also discuss how to reach patients with important information on safe use of medical products—including through the use of local networks, the Internet, and electronic and print media. This will occur within 1 year.
  • Patient safety and reducing medical errors will be a featured topic at OPM’s Fall 2000 annual health plan conference.

Building Purchasers’ Awareness of the Problem

  • Building on existing relationships with purchasers and business coalitions, such as the National Business Coalition on Health, and the Washington (DC) and Midwest Business Coalitions on Health, DOL, HCFA, OPM, and AHRQ will spearhead the QuIC’s efforts to promote collaborative programs with other public- and private-sector partners to increase purchasers’ and providers’ awareness of medical errors as a health care problem and of steps that each can take to address this problem, such as addressing patients’ health literacy skills.
  • At the Federal Benefits Conference (June 2000), OPM will share information about patient safety with representatives from Federal agencies throughout the Nation.

Working with Providers to Improve Patient Safety

  • Through the QuIC, Federal agencies will take advantage of existing resources to promote collaborative patient safety programs involving agency constituents, the health professions community, the public, academia, and other stakeholders, such as the American Medical Association, the American Nurses Association, NPSF, NPSP, and the Quality Forum.
  • VA will develop and run pilot patient safety education programs for medical residents and students.

Using Decision-support Systems and Information Technologies

  • AHRQ and CDC will expand research efforts in the area of informatics to include initiatives aimed at developing and evaluating electronic systems to identify, track, and address patient safety concerns.
  • CQuIPS at AHRQ, along with VA, DoD, FDA and other QuIC member agencies, will evaluate the effectiveness of automated physician order entry systems in hospitals.
  • DoD, VA, and IHS will introduce electronic patient records to offer structured documentation and a common clinical lexicon for practitioners working throughout those systems. The QuIC will encourage other potential Federal participants to do likewise.

Using Standardized Procedures, Checklists, and the Results of Human Factors Research

  • CDC and FDA will work with the DHHS Advisory Committee on Blood Safety and Availability to help ensure that the highest quality standards are met in blood collection and transfusion.
  • Within 1 year, FDA will begin working with manufacturers of medical products to explore incorporating standards, including human factors standards, into guidance to ensure that medical products are designed to minimize the chance of errors.
  • NASA will be invited to become a participant in QuIC activities and bring its understanding and experience in redesigning processes and procedures to enhance safety. Linkages between NASA and the CQuIPS will be established through the NASA Medical Policy Board.
  • The QuIC will sponsor an educational program, noted in the section on research above, to increase the awareness of Federal regulators and policymakers regarding patient safety, human factors, and systems-based improvement.
VA will continue to work with private-sector organizations (e. g., the American Hospital Association and JCAHO) to explore the utility of its comprehensive error analysis and corrective action system.

Author: Center for Disease Control and Prevention and U.S. Department of Health and Human Services

References

Making Health Care Safer: A Critical Analysis of Patient Safety Practices July 2001. Agency for Healthcare Research and QualitySource: Prevention of Medical Errors Continuing Education Ceus, Florida

Joint Commission on the Accreditation of Healthcare Organizations.

U.S. Department of Health and Human Services; Agency for Health Care Research and Quality

 

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