Vol. 4 •Issue 6 • Page 100
The Learning Scope
First Do No Harm: Preventing Medical Errors
The Learning Scope: 2 Contact Hours
Editor’s Note: This course on medical errors is designed for registered nurses and licensed practical nurses to meet the continuing education in nursing by the Florida Board of Nursing, Provider No. 3298, for 2 contact hours. Medical errors is a required course mandated for all Florida nurses. All nurses applying for or renewing their Florida licensure are required to have successfully completed this course prior to their expiration dates. If you have any questions regarding this change, contact the Florida Board of Nursing at www.doh.state.fl.us/mqa/nursing/2001nur_home.html or call 850-488-0595. This article contains valuable information for all nurses and can be used for contact hours in most states.
The goal of this CE offering is to provide nurses with the current information about preventing medical errors. After you have completed reading this article, you will be able to:
1. Identify factors that impact the occurrence of medical errors
2. Discuss public education related to medical errors
3. Specify nursing responsibilities for reporting medical errors
4. Recognize safety needs of special populations
5. Describe error-prone situations
6. Identify processes to improve patient outcomes and
7. Define root cause analysis
“First do no harm.” Medical errors and patient safety seemed an oxymoron when I was a student nurse. Everything that I was learning was directed at keeping patients safe by preventing errors or mistakes before they could happen. Every measure and treatment was carefully considered to provide a safe, healing environment for those precious and vulnerable lives entrusted to our care. But mistakes do happen. Caring, dedicated professionals err in judgment and in action. Systems intended to protect and facilitate healing break down. Laying blame is easy. Accepting the consequences and responsibility of those errors and moving forward to find solutions to prevent their recurrence takes courage, insight and commitment to patients and to our profession.
To Err is Human
A medical error is defined as what happens when something planned as part of medical care doesn’t occur or when a wrong plan is used. The Institute of Medicine (IOM) report in 2000, To Err is Human: Building a Safer Health System, declared that 44,000-98,000 patients die in U.S. hospitals annually from medical errors.1 In this report, President Clinton’s Advisory Commission on Consumer Protection and Quality in the Health Care Industry devoted a chapter to patient safety and health care error. The commission identified a new approach to combat this growing problem: mandatory error reporting to identify and correct system problems, not just clinicians’ mistakes, that are causing or contributing to medical errors.1-3
Recognizing that anyone can miss the mark, a “culture of safety” is being created to encourage reporting of errors for evaluation and correction.4 The Quality Interagency Coordination Task Force (QICTF) was established to coordinate quality improvement activities in federal health care programs. This task force includes the departments of Health and Human Services, Labor, Veterans Affairs, Commerce and Defense. It also represents the Coast Guard, the Bureau of Prisons and the Office of Personnel Management.
The initiative to identify and reduce medical errors is supported by the Agency for Healthcare Research and Quality (AHRQ), whose director, John M. Eisenberg*, MD, MBA, is the operating chairman of QICTF. The goals of QICTF are to improve patient safety protocols at federal hospitals; to create a center for quality improvement and patient safety; to develop regulations requiring those who receive Medicare to implement error reduction programs and to develop new standards for pharmaceutical safety.5,6 JCAHO released a position statement7 supporting the creation of “an effective medical/ health care error reporting system, whether mandatory or voluntary.”
Mistakes happen in health care. This is not a new problem. Leape conducted research about the nature of adverse events in hospitalized patients in 1984.8 Medical errors involve communication, medicines and herbal therapies, surgery, diagnosis, equipment, lab reports, treatments, plans of care, transfers and follow-up care. They happen when communication breaks down, when patients do not or cannot make informed decisions, during routine tasks and during activities of daily living.
New concerns, though, are being raised in the health care community. Nurses have expressed fears that the publicity and focus on mandatory error reporting may lead to increased lawsuits and strained relationships among patients and health care providers. Legal liability risks in daily practice and interactions with patients because of preventable medical errors are increasing. Civil (professional malpractice), administrative (licensure) and criminal litigation are becoming common concerns.
Health care organizations retain legal counsel to assess potential organizational liability and potential claims for compensation or tort claims. Tort claims result if a court finds that negligence by medical practitioners caused injury or death and if jurisdictional requirements are met. Concerns about legal liability when medical errors occur are valid ones.
The greatest defense against litigation, however, continues to be prevention of medical errors, accurate documentation and standardization of practice.
Responsibilities for Reporting
Informing patients begins with public education regarding medical errors before they happen. A statement of principle for informing patients of medical errors was approved by the National Patient Safety Foundation Board of Directors on Nov. 14, 2000.9 Once an error occurs, nurses are obligated to inform patients and their families only as authorized by applicable confidentiality statutes. Typically, attending physicians or designates speak with the patient or family initially about injuries resulting from adverse or sentinel events and the options available to them.
“Mandatory reporting systems” are those systems whose primary purpose is to hold health care providers accountable for reporting errors associated with serious injury or death. Most of these systems are managed by state regulatory programs with the authority to investigate cases and issue penalties or fines for wrongful acts. “Voluntary reporting systems” are those that focus on safety improvement and address errors that resulted in close calls, near misses or minimal patient harm without penalty or fines for the health care provider.
Patient safety is a critical component of quality care. Yet most Americans do not understand the complexities or breadth of health care safety issues. They receive their information through anecdotes, from television, radio or newspapers, and from personal experience. Generally, patient concerns are related to exposure to infection, the level of care they will receive from their providers and the qualifications of the professionals caring for them during their hospitalization. They believe that most medical errors are caused by carelessness or negligence by caregivers who are overworked, worried or stressed.1
The estimated total national cost (lost income and U.S. household production, disability and health care costs) of preventable medical errors resulting in injury is $17 billion-$29 billion annually, with health care costs representing more than half. Medical errors are costly in terms of lives lost, money spent on repeating diagnostic tests or counteracting medication errors, longer hospital stays, added disabilities and in lost trust in the health care system by patients and reduced job satisfaction by caregivers. Organized care systems with unclear lines of accountability in decentralized and fragmented areas that do not communicate effectively with one another contribute to unsafe patient care practices.
Patient safety is a large, complex, costly problem that requires thoughtful, multifaceted responses nationally. The IOM Quality of Health Care in America Committee was established in June 1998 to develop strategies to reduce medical errors and improve patient safety by recommending and prompting action at state and local levels for all patient populations, including for special populations such as the elderly and cognitively impaired.10
What Are Medical Errors?
Medical errors occur when communication breaks down among the health care team and patient; a patient is given the wrong medication; a surgery is done on the wrong patient or wrong body part; a misdiagnosis or inappropriate treatment plan is administered; test results are misinterpreted or not acted upon properly; equipment fails at critical points; nosocomial and postsurgical infections are introduced; blood transfusions are given to a patient with a different blood type than the donor; documentation is incomplete, unclear or inaccurate; processes, such as labeling protocols, are misleading, unclear or nonexistent.
Medical errors can be defined in four ways: adverse events, close calls (near misses), intentional unsafe acts and sentinel events. Adverse events are those untoward incidents, therapeutic misadventures, iatrogenic injuries or other wrongful occurrences directly associated with care or services provided within a health care environment. All adverse events require proper reporting and documentation. Examples of adverse events include but are not limited to the following.
Close calls or near misses are events or situations that could have resulted in an accident, injury or illness but did not do so, either by chance or through timely intervention. Intentional unsafe acts (as they pertain to patients) are events that result from a criminal act, a purposefully unsafe act, an act related to alcohol or substance abuse by an impaired provider or staff, or those involving alleged or suspected patient abuse of any kind. All such events require reporting and documentation.
JCAHO defines sentinel events as “unexpected occurrences involving death or serious physical or psychological injury or risk thereof.” Serious injury specifically includes loss of limb or function (sensory, motor, physiologic or intellectual impairment not previously present that requires continued treatment or lifestyle change). “Risk thereof” refers to any process variation for which a recurrence would carry a significant chance of serious adverse outcomes as determined by medical staff.
Examples of sentinel events include but are not limited to: suicide of a patient in a health care setting where she received around-the-clock care; rape; hemolytic transfusion reaction; and wrongful surgery.
JCAHO began a monthly newsletter in 1998 that identifies specific sentinel events, describes their common underlying causes and suggests steps to prevent future occurrences (www.jcaho.org/ptsafety_frm.html).7 It shares lessons learned and provides recommendations to prevent future medical/ health care errors in health care organizations and gives standards that specifically address safe practices and reduction of risks.
In 2001, JCAHO surveyors began scoring accredited organizations on how they respond to recommendations made in this newsletter.
Preventing Medical Errors
“First do no harm.” Prevent medical errors before they occur. Patient education is critical to helping patients become wiser, better-informed consumers of health care.
Excellent resources are available to help them become better informed about health care, medical errors and their choices in managing risks.11 Use information technology to eliminate reliance on handwriting for ordering medications and treatments. Avoid similar-sounding and look-alike names and packages of medications. Standardize treatment policies and protocols to avoid confusion and reliance on memory that may be tired or have inaccurate information stored in it.
Two key areas where nurses can provide leadership by initiating process actions to prevent medical errors are in medication management and documentation.12
Currently, there are no valid predictors in the research to identify which patients will suffer an adverse event from a medication error, when they will react, or what medication or herbal therapy will cause it. Patient characteristics are not homogeneous.
Medication errors occur at any point in the process of medication administration. There are no cause-and-effect relationships established between ages, comorbidities, types or numbers of drugs received, severity of illness, progression of disease, treatment modalities or intensity of care regimens.
Three major steps of the medication administration process include: 1) point-of-entry written order; 2) dispensing of medication or herbal therapies; and 3) administration of medication or herbal therapies to the patient.
When taking a patient assessment, nurses often neglect to ask the patient about any herbal or over-the-counter medications he may be taking. It is important to note these to avoid adverse reactions with prescribed medications the patient may receive while in the hospital.
The point-of-entry written order prescribes the drug or herbal therapy to be administered, the route and dosage to be given. Errors can happen during prescribing, ordering or transcription of the written order for multiple reasons, e.g., interruptions or distractions when order is being written, incomplete or unreadable orders. Transcription errors can occur if orders are dictated unclearly or with background noise interfering with recording. Avoid verbal orders and clarify, confirm or correct unclear orders before transcribing and administering any medication or herbal therapy.
Dispensing errors can occur when the clinician makes too many formulas, such as adding medications to intravenous solutions, or when pharmacists or pharmacy technicians fill too many prescriptions at one time and become confused or distracted during the process.
It has been noted anecdotally that the number of hours a practitioner works at any given time can lead to fatigue and influence accuracy in dispensing medications.
A U.S. Pharmacopeia study13 found medication errors were most likely to occur during administration. Using the “right” safety rules can prevent administration errors.
Sources of medication errors come in many contexts:
Some common types of preventable medication errors reported in risk management documents and incident reports include but are not limited to the following:
The IOM report1 concluded that 770,000 patients are injured or die each year in hospitals from adverse drug events nationally costing as much as $1.56 billion-$5.6 billion each year. This price tag excluded the costs of injuries to patients and medication errors leading to increased admissions, or malpractice and litigation costs. Patients who experienced medication errors were hospitalized an average of 8-12 days longer than those who did not — an extra $16,000-$24,000.
Computerized medication systems can save hospitals as much as $500,000 annually in direct costs. Computerized medication order entry may prevent an estimated 84 percent of medication errors related to dose, frequency and route. The AHRQ funds grants designed to reduce medical errors by integrating best practices, provider and patient education and further advances in information technology.
Medical data can be collected, collated, stored, analyzed and distributed in unprecedented quantities and put to diverse uses. Patient data is used for claims payment, utilization review, underwriting and coverage decisions, and litigation. Health care providers use the data for research, to collect reimbursement, manage diagnosis and treatment, conduct quality assurance, and monitor other providers.14
Medical records are legal documents, whether in hard copy form or computer-generated, providing proof of the care patients received and their responses to that care. In 80-85 percent of malpractice suits, these records act as the determining factor in providing proof of the standard of care provided at any given time during a patient’s hospitalization.
Medical records are generated by health care practitioners and justify the course of treatment for patients. They establish the patient’s health status and need for care, reflect the care given, and demonstrate the results of that care. These records allow exchange of information among members of the health care team about the patient’s condition and treatment, holding team members to professional accountability. They contain the following:
Documentation errors in a medical record can have serious medical and legal consequences. When health care practitioners deviate from the accepted standard of medical practice and this deviation results in harm to the patient, it is malpractice.
The statute of limitations for filing a lawsuit in Florida is 2 years from the time malpractice originally happened. Medical records that are poorly maintained, incomplete, inaccurate, illegible or altered create doubt regarding the treatment given to the patient and can cause a jury to find the health care practitioner liable.
Elements of Documentation
Prevent medical errors by documenting defensively. When making entries on patients’ charts, always attend to the following general guidelines.
1. Make sure you have the correct chart before you begin documenting your entries.
2. Write legibly and neatly — print if necessary.
3. Use only proper and accepted abbreviations approved and used by your facility and/or profession. Avoid misleading abbreviations.
4. Be factual and descriptive. Use objective information. Rely on what you see, hear, feel or smell. Subjective data, such as patient comments, should be entered in quotes. Record exact words as much as possible. Provide clear, concise, accurate information.
5. Don’t guess, generalize or write personal opinions or statements.
6. Make sure entries are accurately dated and timed. The words “late entry” identify information entered out of proper time sequence. Then record the proper date and time the actual event occurred.
7. Document with a jury in mind.
8. Erasures, writing over and/or obliterating entries are illegal charting. When misinformation is written, draw a line through the entry with “error” and your initials noted above the line. Then enter the correct information.
9. Chart procedures and tests only after they are done, not in advance.
10. If informed consent was needed, document that the patient was given accurate information and the opportunity to ask questions before signing the consent form.
11. Document the patient’s presenting problem(s) or complaint(s).
12. Record the patient’s symptoms and what interventions or treatments were done. How did the patient respond to those interventions or treatments?
13. Protect your signature! Do not leave any blank spaces before your signature on a chart. Draw a line between spaces to your name, if necessary.
14. Note communication among health care team members.
15. Chart all instances of patient noncompliance or refusals of recommended treatment. Note that the patient was informed of potential consequences.
16. Transfer and discharge documentation includes medications, patient status (vital signs and health stability), and any instructions given to the receiving nurse on transfer or to the patient and his family members/ guardian upon discharge.
17. Prepare the patient for transfer or transport. Monitor the patient until the transfer or transport is complete. Give a copy of the chart and a full report to the transfer or transport team. Carefully and thoroughly document each action in the patient’s chart.
Root Cause Analysis
Perfect performance is not possible. Factors that lead to medical errors are complex and multifaceted.
Root cause analysis (RCA) is a process for identifying basic and contributing causal factors underlying variations in performance associated with adverse events, close calls and sentinel events. An RCA asks what and why, looking at special and common causes. It identifies changes possible in systems and processes through redesign or development of new processes or systems to improve performance and reduce risk of the event or close-call recurrence. The RCA determines potential improvement in processes or systems tending to decrease the likelihood of such events in the future or that no such improvement opportunities exist.
For an RCA to be credible, it is important for the facility leadership and those people most closely involved in processes and systems under review to be involved. Internal consistency must be present. All obvious questions must be answered, and the information cannot contradict itself. All relevant literature related to the medical error needs to be considered and evaluated. Corrective actions, outcome measures and top management approval is important for a valid root cause analysis.
There are four basic action steps in creating a root cause analysis.
1. Risk management or quality management reviews each incident report and assigns a safety assessment code (SAC) for follow-up.
2. RCAs are conducted for adverse events based on an SAC matrix scoring process.
3. The format for RCA will be based on each facility’s patient safety improvement policy and/or handbook.
4. RCAs do not involve sworn testimony. (RCAs can be used to generate quality assurance documents only if this is established in writing at the beginning of the review.)
Reporting Results of RCA
Complete an incident report when a patient is involved in an event that either harmed or has the potential of causing harm. The first employee learning of or witnessing a close call, adverse or sentinel event completes the report during her tour of duty. If a nonclinical person discovers the event, she will confer with the clinical staff to complete the clinical information on the report. Documentation includes a description of the event, its location, diagnosis, the patient’s mental status, and any medications or herbal therapies taken within 24 hours of the incident.
Once the incident report is completed, it goes immediately to the physician or person responsible for the patient’s care. That person examines the patient following the incident in order to record a statement of the findings, the results or status of requests for X-rays and/or laboratory tests where indicated, and the follow-up, as needed. Incident reports and root cause analyses are not placed in a patient’s medical or administrative record nor are references made to either one. However, a progress note is entered describing what occurred, the results of evaluation and treatment provided. All incident reports and RCAs are forwarded to appropriate supervisors and risk management personnel.
Medical errors are a major concern for all nurses.15 Identification of causal factors comes from all disciplines and team members. Training and education with continual reinforcement throughout your professional career are needed to reduce medical errors in all health care arenas. Nurses have a legal responsibility to maintain detailed medical records.
Only a factual, consistent, timely and complete medical record will defend us against allegations of negligence, improper treatment and omissions in care. Nurses protect themselves legally by being clinically competent, understanding relevant laws and accepting the legal doctrine of professional accountability. Even one death from a medical error is too many. First — and last — do no harm.
By preventing medical errors, we can reduce exposure to liability risks and, at the same time, protect those patients who have placed their lives and trust in our hands.
1. Kohn, L.T., Corrigan, J.M., & Donaldson, M.S. (Eds.). (2000). To err is human: Building a safer health system. Washington, DC: National Academy Press. Retrieved Jan. 15, 2002 from the World Wide Web: http://www.nap.edu/books/0309068371/html
2. Institute of Medicine. (1999). Medical errors in the U.S. medical system. Washington, DC: National Academy Press. Retrieved Oct. 12, 2001 from the World Wide Web: http://www.coloradohealthnet.org/books/book13.html
3. Brennan, T.A. (2000). The Institute of Medicine report on medical errors: Could it do harm? New England Journal of Medicine, 342(15), 1123-1125.
4. State of Florida, Department of Health. (2001, September). Provider guidelines. Jacksonville, FL: Division of Medical Quality Assurance, Florida Board of Nursing.
5. Eisenberg, J.M. (2000, February). Medical errors: The scope of the problem. Fact sheet. Publication No. AHRQ 00-P037. Rockville, MD: Agency for Healthcare Research and Quality. Retrieved Jan. 7, 2002 from the World Wide Web: http://www.ahrq.gov/ qual/errback.htm
6. Agency for Healthcare Research and Quality. (2000, February). Report to the president on medical errors. Rockville, MD: Author. Retrieved March 6, 2001 from the World Wide Web: http://www.quic.gov/report
7. Joint Commission on Accreditation of Healthcare Organizations. (February 2002). Patient safety/sentinel events. Oak Brook, IL: Author. Retrieved Jan. 4, 2002 from the World Wide Web: www.jcaho.org/ ptsafety_frm.html
8. Leape, L.L., et al. (1991). The nature of adverse events in hospitalized patients. Results of the Harvard Medical Practice Study II. New England Journal of Medicine, 324(6), 377-384.
9. National Patient Safety Foundation. (2000, November). Talking to patients about health care injury: Statement of principle. Chicago: National Patient Safety Foundation. Retrieved Feb. 18, 2002 from the World Wide Web: http://www.npsf.org/html/statement.html
10. National Patient Safety Foundation. (2002, February). Retrieved Feb. 18, 2002 from the World Wide Web: http://www.npsf.org/
11. MCW HealthLINK. (2001). 20 tips to help prevent medical errors. Milwaukee: Medical College of Wisconsin. Retrieved Dec. 10, 2001 from the World Wide Web: http://healthlink.mcw.edu/article/ 962111066.html
12. Southam, A.M., Reisman, L., & Sullivan, T.A. (2001). Medical errors: Getting past the oops! Panel discussion on Health Care 2001: A symposium on health care risk management. Retrieved Feb. 20, 2002 from the World Wide Web: http://www.amre.com/content/iw/ hcs2001/hcs2001-mederrors.html
13. Prager, L.O. (2001, Jan. 15). Database tracks causes of hospital medication errors. AMNews. Chicago: American Medical News. Retrieved Jan. 12, 2002 from the World Wide Web: http://www.ama-assn.org/scipubs/amnews/ pick_01/prsd0115.htm
14. Manning, B. (1997). Medical records, privacy & confidentiality. Retrieved Feb. 18, 2002 from the World Wide Web: http://www.netreach.net/~wmanning/privacy.htm
15. Florida Department of Health (2001-2002). Continuing education: Nursing: Medical errors. Retrieved Feb. 20, 2002 from the World Wide Web: http://www9.myflorida.com/mqa/nursing/2001nur%5Fceu.html
Diana Swihart is a nurse educator at the James A. Haley Veterans’ Hospital, Tampa, FL, and president of the Suncoast Educators Association in Tampa.