Florida Physical Therapy: Reducing Medical Errors
Creating a Culture of Safety for PTs and PTAs
Nancy Evans, BS
Lauren Robertson, BA, MPT
This course is approved by the Florida Physical Therapy Association, course number ME80111831. It meets the Florida requirement for prevention of medical errors for physical therapists (Florida Statute Rule No. 64B17-9), for initial licensure and biennial renewal.
Accreditation of this course does not necessarily imply the FPTA supports the views of the presenter or the sponsors.
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LEARNING OBJECTIVES
Upon completion of this course, you will be able to: |
- Summarize common types of medical errors, including adverse and sentinel events.
- Name the factors that increase the risk of medical errors.
- Identify populations of special vulnerability and discuss ways to address their needs.
- Describe common risks from falls and evaluate ways to prevent them.
- List medication errors and discuss ways physical therapists can help ensure accurate medication delivery.
- Identify key concepts for proper medical documentation and communication.
- Discuss professional and legal responsibilities for reporting medical errors and sentinel events.
There is a hidden epidemic in the United States. It is an epidemic of medical errors, resulting in injury to 1 in every 25 hospital clients and tens of thousands of deaths each year (IOM, 1999). Medical errors are more deadly than breast cancer, motor vehicle accidents, or AIDS. The Institute of Medicine's To Err Is Human: Building a Safer Health System reports that medical errors cost the economy as much as $29 billion each year (IOM, 1999).
To Err Is Human made headlines across the country, with predictable impact on the national agenda. From local hospitals and clinics to state and federal agencies, medical errors became a priority. Five examples follow:
- 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.
- Twenty-three states, including Florida, have mandatory or voluntary systems for reporting medical errors in hospitals and other healthcare organizations (Gebhardt, 2005).
- The Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) requires that healthcare institutions analyze serious medical errors to determine the root cause and develop an action plan to prevent those errors in the future.
- In December 2000 Congress approved a $50 million annual appropriation for research on client safety, primarily by the Agency for Healthcare Research and Quality (AHRQ).
- In July 2005 President Bush signed into law S.544, the Patient Safety and Quality Improvement Act, which established a voluntary confidential reporting system to create a national database of medical errors for analysis and development of evidence-based client safety measures.
Florida has taken other important steps to prevent medical errors and improve client safety. Handwritten prescriptions are now illegal in Florida. In 2004 the state established the Florida Client Safety Corporation, a voluntary statewide reporting program to track and analyze near misses in healthcare. The same legislation requires the state to make public important performance outcome indicators for healthcare facilities (eg, volume of cases, average length of stay, complication rates, mortality rates, infection rates for various medical conditions). This information became available online in November 2005 at http://www.floridacomparecare.gov.
In November 2004 voters approved two controversial amendments to the Florida constitution that could reverse many of the client safety initiatives in the 2004 legislation. The Clients' Right-to-know About Adverse Medical Incidents Act allows clients who have been harmed to gain access to all records of their care, including documents of provider deliberation.
The Three Strikes and You Are Out Act asks the Florida Board of Medicine to revoke medical licenses from providers who have had three adjudicated malpractice incidents. An unintended consequence of these amendments has been a chilling effect on reporting and discussion of adverse events, which imperils the research that needs to happen (Barach, 2005). It is possible that the passage of the federal Client Safety Improvement Act of 2005, which protects the reporting of adverse events, may preempt Florida's Three Strikes, but it is too early to tell.
The AHRQ has shown that medical errors result most frequently from systems errors—the organization of healthcare delivery and the ways resources are provided in the delivery system. Only rarely are medical errors the result of the carelessness or misconduct of a single individual.
Donald Berwick, MD, president and CEO of the Institute for Healthcare Improvement, points out:
Experts believe that client safety is slowly improving. However, the public and healthcare providers remain concerned and are impatient with the pace. According to a recent survey, 40% of the people questioned said the quality of care has gotten worse in the past five years. Only 17% said the quality of care had improved (Kaiser Family Foundation, 2004).
A survey of hospitals in Missouri and Utah in 2002 and 2004 showed that, although three-quarters of hospitals reported implementing a written client safety plan, about one-tenth reported having no written plan at all. Only a third of the hospitals had fully implemented computerized physician order entry (CPOE) for prescription drugs by 2004, and only 3% of the hospitals implementing CPOE required physicians to use them. According to the researchers, "Quality systems are improving, but such change takes time, progress is slow, and the gap between the best possible care and actual care remains large" (Longo et al., 2005).
Errors can occur at any point in the healthcare delivery system. Acknowledging that errors happen, learning from them, and working to prevent future errors represents a major change in the culture of healthcare—a shift from blame and punishment to analysis of the root causes of errors and creation of strategies to improve. Every person on the healthcare team has a role in making healthcare safer for clients and workers.
TYPES OF ERRORS
The IOM report defines an error as "the failure of a planned action to be completed as intended (an error of execution) or the use of a wrong plan to achieve an aim (an error of planning)." Research on medical errors tends to focus on the medical and nursing professions, although practices that lead to medical error are clearly not limited to those professions. Physical therapists engage in many of the same practices and are subject to the same conditions that are known to cause medical errors.
An adverse event is an injury caused by medical management rather than the underlying condition of the client. 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 the reasons that humans make errors (Reason, 1990) has identified two types of errors: active and latent. 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, they are errors in system design, faulty installation or maintenance of equipment, or ineffective organizational structure.
The effects of latent errors may not appear for months or even years but they can lead to a cascade of active errors that ends 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, causing 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).
A physical therapist who notices a discrepancy between written weightbearing orders and the type of procedure done by the orthopedic surgeon and calls the error to the attention of the treating doctor has also prevented an adverse event. Close calls provide opportunities for developing preventive strategies and actions, and they should receive the same level of scrutiny as adverse events.
The Florida Client Safety Corporation (FPSC) was established not as a regulatory agency but as a learning organization to create a Near Miss Reporting System (NMRS) as a website in 2006 that will help healthcare providers improve the quality and safety of care and reduce harm to clients. Under the NMRS:
- Reporting will be voluntary, anonymous and independent of mandatory reporting systems used for regulatory purposes.
- Reports of near-miss data will be published regularly.
- Special alerts will be published regarding newly identified, significant risks.
- Aggregated data will be made publicly available.
- Performance and results of the near-miss project will appear in its annual report.
Surgical Errors
Surgical errors, or surgical adverse events, may account for a high percentage of total adverse events. A study of hospitals in Colorado and Utah found that surgical errors accounted for two-thirds of all adverse events and 1 of 8 hospital deaths (Gawande et al., 1999).
A review by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) found that wrong-site surgery was most common in orthopedic procedures. Risk factors contributing to 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, wrong-procedure, or wrong-person surgery, are not the sole responsibility of the operating surgeon. All operating room personnel have a role in ensuring client safety by verifying the surgical site and pointing out a possible error. To reduce the risk of wrong-site, wrong-procedure, or wrong-person surgeries, JCAHO developed a Universal Protocol, which all accredited healthcare organizations were required to implement by July 2004 (JCAHO, 2004).
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, University of Pittsburgh researchers found that up to 12% of reviewed specimen pairs had an erroneous diagnosis, primarily due to suboptimal specimen collecting. Nearly 40% of those errors resulted in harm to clients (Raab et al., 2005).
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. Fifty-two of the 55 reported cases of delays in treatment resulted in client death.
Medication Errors
Medication errors are one of the most common types of error, and are of primary concern to nurses who administer them, practitioners who prescribe them, and pharmacists who dispense them. Medication errors are called preventable ADEs. In 2005 U.S. Pharmacopeia (USP) reported that MEDMARX, the largest nongovernmental database of medication errors, has received more than 1 million medication error records since the program's inception in 1998. About half of the reported errors reached the client; however, 98% resulted in no harm (USP, 2005).
According to researchers from AHRQ and the National Center for Health Statistics, ADEs resulted in an estimated 4.3 million physician visits in the United States during 2001, up from 2.7 million such visits in 1995. Women 65 to 74 years of age had the highest incidence of ADEs (Zhan et al., 2005).
Florida took a simple but important step to improve client safety on July 1, 2003, when s.456.42, F.S. went into effect. This law requires physicians in Florida to either print legibly or type prescriptions and to include the name and strength of the drug prescribed, the quantity of the drug prescribed in both textual and numerical formats, and the directions for taking the drug.
What important step to improve client safety did Florida start on July 1, 2003? The state:
- Requires that physicians read each prescription to the client so they know what it says in case the pharmacist asks.
- Requires the physician to check if the client has allergies and document on the prescription.
- Requires that physicians, who write illegible prescriptions, be reported to their licensing board.
- Requires physicians in Florida to either print legibly or type prescriptions.
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); category includes dispensing or administering the wrong drug
According to USP's frequently asked questions (2005):
- The primary contributing factors to medication errors were distractions, workload increases, and staffing issues such as inexperienced or temporary staff and insufficient staffing. Many of these factors may have resulted from efforts at cost containment.
- Insulin, heparin, warfarin, and albuterol were the medications most often associated with errors.
One study funded by AHRQ in two tertiary care hospitals found that errors in ordering medications accounted for 56% of preventable ADEs, while errors in administering medication accounted for 34% of preventable ADEs (Bates et al, 1995). A second study 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 (Leape, 1995).
A later study to identify risk factors for preventable ADEs among clients admitted to medical and surgical units at two large hospitals found few such factors, suggesting that focusing on improving medication systems would prove more effective (Bates et al., 1999).
Computerized prescriber order entry (CPOE) is helping many hospitals reduce ADEs but it has not eliminated medication errors. The USP reported that nearly 20% of hospital and health system medication errors reported to MEDMARX in 2003 involved computerization or automation (such as automated dispensing devices used in client care areas of more than half of U.S. hospitals). Nearly half of all CPOE errors were dosing errors (extra dose, wrong dose, or omission). Because of computerization, however, only 1.3% of those errors resulted in client harm (USP, 2004).
University of Pittsburgh researchers reported an unexpected increase in pediatric critical care mortality after implementation of a CPOE (Han et al., 2005). This study of children transported to a hospital for specialized care found that CPOE was associated with an increase of 3.86% in mortality, suggesting that hospitals should continue to monitor mortality rates as well as medical errors once CPOE systems have been implemented.
Patient-controlled analgesia (PCA) pumps can also result in medication errors, more than tripling the risk of client harm. According to the USP, the most common types of error involving PCA pumps were improper dose/quantity, unauthorized/wrong drug, and dose omission. Despite the built-in safety features of PCA pumps—including a lockout interval that sets a minimum time between each dose and a maximum allowable dose during a specified time period—medication errors involving these pumps continue (USP-CAPS, 2004). USP recommendations for preventing errors with PCA pumps are included in Box 1.
| BOX 1 |
PREVENTING ERRORS IN PATIENT-CONTROLLED ANALGESIA |
- Include bar codes on all PCA medications in facilities where point-of-care bar code systems or other item identification technology (e.g., radio frequency identification) are implemented.
- Conduct a failure modes and effects analysis (FMEA) for existing pumps, as well as for new pumps that are brought into the facility. Consider what default settings are preprogrammed. Consider if the pumps can be programmed by drug (eg, morphine PCA vs. hydromorphone PCA). Consider if the pump resets to a default (other than "000," which would require active entry) after it turns off.
- Perform double-checks for initial setup and maintenance, and dose changes/change orders. Double-check clamp (to open position) before closing the pump. Check that the pump is turned on. Check whether connections are to IV or epidural lines to prevent wrong-route errors. Check for kinked tubing in the pump door.
- Educate staff about sound-alike and look-alike drugs, especially when bar code technology is not part of the existing system. Many drug errors with PCA pumps are due to name confusion (eg, morphine, hydromorphone, meperidine).
- If using preprinted order forms, prohibit writing over information on the form.
- Educate clients, family members, and staff (including physical therapists, x-ray technicians) about the use of the pumps. Written instructions should be provided to clients. Instruct family members NOT to administer PCA doses—PCA by definition should be administered at the client's perception of need. Document education of client and family members.
Additional recommendations and case studies are found in Quality Review 81 at http://www.usp.org/clientSafety/briefArticlesReports/
qualityReview/qr812004-09-01.html
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High-alert (high-risk/high-hazard) drugs such as neuromuscular blocking agents, chemotherapy agents (some of which are carcinogens), and opioid analgesics require special precautions to prevent catastrophic errors. Although many of these drugs carry a black box warning (BBW), the FDA's strongest labeling requirement, one recent study indicates that some physicians and pharmacists may ignore BBWs in prescribing and dispensing drugs (Wagner et al., 2005).
The Institute for Safe Medical Practices recommends the following measures to prevent catastrophic errors with neuromuscular blocking agents:
- Limit access. When possible, dispense neuromuscular blocking agents from the pharmacy as prescribed for clients. Allow floor stock of these agents only in the OR, ED, and critical care units where clients can be properly ventilated and monitored.
- Segregate storage. When these agents must be available as floor stock, have the pharmacy assemble the vials in a sealed box with warnings affixed as noted below. Sequester the boxes in both refrigerated and nonrefrigerated locations.
- Warning labels. Affix fluorescent red labels that note: "Warning: Paralyzing Agent–Causes Respiratory Arrest" on each vial, syringe, bag, and storage box of neuromuscular blocking agents. Commercially available labels can be purchased from United Ad Label Co. Call 1-800-992-5755 and order item #AM282. (ISMP, 2005).
Even though physical therapists do not write prescriptions or dispense drugs, they are in a position to identify errors and can protect the patient by preventing adverse events. Physical therapists should always discuss any medication discrepancies with the nursing staff or the prescribing physician. It is useful for PTs to remember the six " rights" followed by nurses when administering drugs:
- 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 2). If hospitals implemented all of these practices, it could markedly reduce medication errors.
| BOX 2 |
BEST PRACTICES FOR MEDICATION SAFETY |
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To reduce the occurrence of adverse drug events (events that can cause, or lead to, inappropriate medication use and patient harm),
Clients 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
- Standardize drug packaging, labeling, storage
- Use "unit dose" drug systems (packaged and labeled in standard patient doses)
Purchasers can:
- Require machine-readable labeling (barcoding)
- Buy drugs with prominent display of 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, clients should ask the following questions before accepting prescription drugs:
- Is this the drug my doctor (or other health care provider) ordered? What are the trade and generic names 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?
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Practice Errors
A recent study involving thirty-five occupational therapists (OTs) in four states explored the concept of practice errors. The OTs identified the following items as examples of practice errors:
- Causing physical harm to the patients
- Delaying patient discharge
- Creating unrealistic treatment and/or prognosis expectations
- Providing unneeded services
- Failure to provide needed services (Scheirton et al., 2003)
The participants also identified these practices as contributing to practice errors:
- Psychosocial errors
- Showing lack of confidence in front of a patient
- Withholding information about a patient's prognosis
- Lack of needed equipment
- Incorrect equipment installation
- Poor equipment design
- Wrong or unclear physician orders
- Unclear, insufficient or illegible documentation
- Communication breakdown among service providers
- Productivity pressure
- Lack of experience (Scheirton et al., 2003)
The results of the OT study add to the findings of the Institute of Medicine and other groups who are working to expand the definition of medical errors. Lack of a standardized nomenclature complicates the development of an effective industry-wide response. The term medication error was originally used to describe medication errors committed by doctors, nurses, and pharmacists. But this term clearly comes up short when the discussion turns to a host of practice errors not related to medications. Recall the Institute of Medicine's earlier definition of medical error:
- An error is defined as the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim.
To ensure consideration of all relevant issues related to medical errors, the Quality Interagency Coordination Task Force (a federal entity overseen by the AHRQ), has expanded the definition as follows:
- An error is defined as the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim. Errors can include problems in practice, products, procedures, and systems.
Under this expanded definition, patient safety encompasses three complementary activities: preventing errors, making errors visible, and mitigating the effects of errors. This broadening of the definition of medical errors is important for physical therapists because it acknowledges that practice errors are committed by all healthcare providers—not just nurses, pharmacists, and doctors.
Participants in the OT study reported they experienced strong emotional reactions to practice errors and also reported lasting changes in their own practice habits as a result of the errors. But, as with the USP report discussed earlier, in which almost a third of the personnel involved with initiating or perpetuating an error were reportedly not informed of their involvement in the error event, errors are often not discussed with other medical professionals, nor are system-wide steps taken to prevent others from committing the same error.
System Failures
Analysis of medical errors continues to show that human fallibility is only part of the picture. System failures are also guilty. In a major study, Leape and colleagues (1995) showed that failures at the system level—in disseminating pharmaceutical information, in checking drug dosages and client identities, and in making client information available—were the real culprits in more than 75% of adverse drug events. In 2005 Pauker and colleagues stated:
Cost containment is a system-level factor that can affect medical errors. According to researchers at AHRQ, financial pressure at hospitals is associated with increases in the rate of adverse events. Using the Healthcare Cost and Utilization Project (HCUP) State Inpatient Data for Florida, they found that clients have significantly higher odds of experiencing AEs when hospital profit margins decline over time. These include nursing-related AEs, surgery-related AEs, and all likely preventable AEs (Encinosa-Bernard, 2005).
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 acceptability 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 clients and staff.
FACTORS 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):
- Fatigue. Working a double shift, for example, can increase the likelihood of errors. Medical residents on call for 24 hours or more are also at high risk for errors. Research shows how such system-based changes as reducing the work hours of medical personnel can reduce the error rate in hospitals (Landrigan et al., 2004).
- Alcohol and/or other drugs. Use of alcohol and/or drugs is incompatible with competent, professional, safe client care. Unfortunately, the combination of high stress and easy access to medications has led to substance abuse by physicians, nurses, and other healthcare professionals.
- Illness. Coming to work when you aren't well jeopardizes your health and the health and safety of clients.
- Inattention/distraction. A noisy, busy emergency department can make it difficult to concentrate on one client's care, especially if you know that other clients 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 clients, 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 clients is one of the most common reasons for error.
- Hard-to-read handwriting. Physicians' 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).
Handwashing Noncompliance
Nosocomial (hospital-acquired) infections occur in about 7 to 10 percent of hospitalized patients and account for approximately 80,000 deaths per year in the United States. Since most hospital-acquired pathogens are transmitted from patient to patient via the hands of healthcare workers, handwashing has been proven the simplest and most effective method to reduce the incidence of nosocomial infections (Making Healthcare Safer, 2001).
Although the practice of handwashing has been proven effective, compliance with recommended hand hygiene practices is poor. A recent review of eleven studies noted that the level of compliance with basic handwashing ranged from 16 to 81 percent. Recent surveys demonstrate that although most healthcare workers recognize the importance of handwashing in reducing infections they routinely overestimate their own compliance with this procedure (Making Healthcare Safer, 2001).
Problems with Medical Devices
Physical therapists use a variety of devices, and they are often responsible for ordering and sometimes even repairing equipment in their facilities. The use of electrical stimulation, EMG, ultrasound, range-of-motion devices, lifts, wheelchairs, handheld and computerized testing equipment, whirlpools, exercise equipment, and other devices is common in physical therapy practice. Design flaws, misuse, and malfunction are all common causes of medical errors.
Data collected by the United States Food and Drug Administration (FDA) in the late 1980s demonstrated that almost half of all medical device recalls resulted from design flaws. In 1990, Congress passed the Safe Medical Devices Act (SMDA), which requires that designs be "appropriate and address the intended use of the device, including the needs of the user and patient." The application of human factors principles during a device's design has been demonstrated to reduce user error (Making Healthcare Safer, 2001).
Under the SMDA, a facility (hospital, ambulatory surgical center, nursing home, or outpatient center) is required to report to the FDA anything that reasonably suggests that a medical device contributed to the death of a patient or caused serious injury or illness to a patient. Facilities are also required to submit a semiannual report to the Secretary of Health and Human Services summarizing incidences of death, injury, and illness attributed to medical devices (Making Healthcare Safer, 2001).
| CASE 1 |
A PT is instructing two nursing assistants (CNAs) in the use of a Hoyer lift to transfer a 400-lb woman from her wheelchair back to her bed. The lift was rated for use only up to 250 lb. The facility was unable to rent (and unwilling to purchase) a larger and stronger lift for this patient and felt that transferring her with improper equipment outweighed the risks associated with her confinement to bed. The facility decided that having a PT supervise the transfers reduced the risk of an adverse event.
With the PT supervising, the patient was placed in the lift and elevated into the air above her wheelchair. As the CNAs turned the lift toward the bed it began to sink because the lift arm couldn't handle the weight of the patient. In an attempt to complete the transfer before the patient was below the level of the bed, the CNAs swung the lift quickly towards the bed. The lift tilted dangerously to the side and the legs started to move together, narrowing the base of support. The CNAs pushed the lift quickly toward the bed and it tipped sideways depositing the patient heavily onto the edge of her bed, her large body half on and half off the bed.
No one was injured and there was a sigh of relief that the transfer had been completed. The PT warned the CNAs that the lift was not sturdy enough for this patient but the CNAs said they were under orders to get the woman out of bed using whatever equipment was available. The PT reported the near-fall to her supervisor, the charge nurse and the facility administrator but did not document the incident. She (or another therapist) continued to supervise the CNAs during subsequent transfers in the belief that skilled supervision was better that no supervision.
Despite continual supervision, several days later the lift fell over during a transfer, the patient was dropped to the floor, and the lift fell on top of her. When the PT learned of this incident she called the state Department of Health Services and reported the equipment malfunction. The DHS sent an investigator to the facility but no citation was issued and no action was taken. The PT was privately admonished by the charge nurse who said, "You made me look like a fool and shouldn't have called the state."
Is the PT guilty of negligence in this case? How about the charge nurse? Should she have refused to participate in the transfer training, knowing that the CNAs would have used the inappropriate equipment even without her supervision? Is this a practice error? Is this equipment failure? What should the PT have done in this situation?
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POPULATIONS OF SPECIAL VULNERABILITY
The safety of all clients is of paramount concern for all care providers. However, some clients—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 healthcare team, most commonly related to communication issues. Nurses and other care providers need to recognize the special needs of these clients and act accordingly.
Older Clients
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 clients 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 clients and care providers, potentially leading to errors.
Older clients are at special risk from 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 clients, communication with a responsible family member or other client advocate is essential.
Older clients 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 client, the greater the risk of serious medication errors with devastating effects. Weight-based dosing is required for almost all pediatric drugs, and errors often occur when physicians or pharmacists convert dosage from pounds (for adults) to kilograms (for children). The USP advises that parents should know their child's weight in kilograms and reconfirm with the doctor that the dosage is correct for that weight.
One research study in two urban teaching hospitals found that errors occurred in 5.7% of medication orders during the care of 1,120 pediatric clients admitted during 1999 (Kaushal et al., 2001). In addition, the rate of potential ADEs (close calls or 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 client drug allergies, drug dosage, and drug-drug interaction) could have prevented most of the potential ADEs, as could including clinical pharmacists in ward rounds. Nearly 80% of potential ADEs occurred in drug ordering, and 34% involved incorrect dosing.
Infants and young children do not have the communication abilities needed to alert clinicians about 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.
Limited English Skills or Limited Literacy
Meeting the healthcare needs of Florida's culturally and ethnically diverse population may require bilingual care providers, translators, 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 clients who do not speak English. 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 health professionals caring for patients from 23 different cultural groups can be found in Culture and Nursing Care: A Pocket Guide (Lipson, Dibble & Minarik, 2005). 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 neurologic impairment, assistive devices such as an alphabet board, a picture board, or a 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 clients are not the only population at risk. Any client who has had excessive blood loss may experience postural hypotension, increasing the risk of falling. Maternity clients or other clients 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 3.
| BOX 3 |
RISK FACTORS FOR FALLS |
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Risk factors for falls include the following:
- 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.
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Physical therapists regularly treat patients who are at risk for falls and there is good evidence that a well-designed fall intervention and treatment program significantly reduces the risk for falls in both institutionalized and community-dwelling adults. Studies by Tinetti et al and other researchers have shown that falls can be significantly reduced when risk factors are addressed.
In one well-known study by Tinetti and colleagues (1994), fall risk was reduced in community-dwelling older adults when certain risk factors were targeted for intervention. Targeted risk factors included review of postural hypotension, use of sedative-hypnotic agents, use of more than four medications, environmental hazards, transfer problems, and gait and strength abnormalities. Treatment included adjustment of medications, PT instruction and home exercise program, home modifications, and periodic monitoring for falls.
In another study by Shumway-Cook and colleagues (1997), fall risk was decreased by up to 33 percent in community-dwelling older adults by identifying specific balance impairments and addressing the impairment with outpatient PT and an individualized home program.
In 2001 Health Canada published a comprehensive report called A Best Practices Guide for the Prevention of Falls Among Seniors Living in the Community . The report recommended evidence-based "best practices" in seven areas: exercise, environment modification, education, medication, clinical intervention, multi-factorial intervention, and health promotion. Many of the findings are relevant to PT practice, including the following:
- Exercise programs that had a statistically significant reduction in falls had a balance training component, but more research is needed to determine what type of exercise programs are effective in reducing falls.
- Benefits from an exercise program are short-lived if the program is stopped.
- Environmental modification is most effective when combined with education and counseling.
- Education is not effective alone but may be effective when combined with a comprehensive risk-reduction program.
- Benzodiazepines increase fall risk.
- Decreasing the use of psychotropic drugs reduces falls. (Health Canada, 2001)
In 2001 the AHRQ published a review of several studies that looked at interventions intended to reduce the incidence of falls in healthcare facilities. The review examined a number of practices often used in an effort to decrease falls in medical facilities. These practices include the use of physical restraints and bedrails, bed alarms, special flooring, and hip protectors.
PHYSICAL RESTRAINTS, BEDRAILS, AND BED ALARMS
There is reason for concern regarding each of these interventions. Mechanical restraints can cause severe injury, strangulation, and mobility limitations that may predispose patients to other adverse outcomes (pressure ulcers, incontinence, confusion). Restrained patients appear to have a modest increase in fall risk and fall injuries based on several studies.
Restraints also limit mobility, a shared risk factor for a number of adverse geriatric outcomes, and increase the risk of iatrogenic events. They certainly do not eliminate falls, and decreasing their use can be accomplished without increasing fall rates. In some instances reducing the use of restraints may actually decrease the risk of falling (Making Healthcare Safer, 2001).
Although the use of bedrails has decreased in recent years, they are still widely used in medical facilities to prevent injury from falls. According to the ARQH, however, the potential for harm with use of bedrails is well-documented, most notably death from a variety of mechanisms including strangulation. Several studies reveal no statistically significant difference in falls compared with historical controls when bedrails are removed (Making Healthcare Safer, 2001).
According to the AHRQ, there is insufficient evidence regarding the effectiveness of bed alarms in preventing falls in elderly patients to recommend the practice (Making Healthcare Safer, 2001).
SPECIAL FLOORING
One proposed practice to prevent injury from falls is to alter flooring material on hospital wards and in nursing homes. Carpeting, soft vinyl, or other materials could potentially improve falls outcomes. One such product, the Penn State Safety Floor, is designed to remain relatively rigid under normal walking conditions but to deform elastically to absorb impact forces during a fall.
One study showed an increase in the number of falls with carpeting but a decrease in the rate of injuries. The choice of specialized flooring could be made either to reduce the risk of falling or to reduce the risk of an injury once a fall has occurred, or both (Making Healthcare Safer, 2001).
HIP PROTECTORS
External hip protectors appear to be an effective means to reduce the risk of a hip fracture in persons aged 65 and over who fall. Discomfort from wearing the device, difficulty managing the garment while dealing with continence, and the potential for skin irritation and breakdown are causes for concern in fragile older people. Although long-term compliance is low, there is strong evidence to support the ability of hip protectors to prevent hip fractures (Making Healthcare Safer, 2001).
MEDICATION ISSUES IN PT PRACTICE
Although in most practice settings PTs do not prescribe medications, they do administer medications in limited situations (iontophoresis, phonophoresis) and work closely with patients taking a wide variety of prescription and over-the-counter (OTC) drugs. Whether PTs are working in an outpatient clinic, hospital, nursing home, home health agency, sports setting, or pediatrics department, they come in daily contact with clients using a variety of medications.
Physical therapists need to be knowledgeable about the medications their patients are taking, including indications and contraindications. They should have a knowledge of pharmacology adequate to recognize when a client is having a poor response to a medication, and they can play a vital role in making a referral to an appropriate practitioner when there is a change of condition or an emerging medical problem.
In the past many PT programs did not offer pharmacology courses, although this is changing rapidly as graduate-level and doctoral programs add pharmacology to their required coursework. The U.S. Army pioneered pharmacology training for PTs when, more than 20 years ago, they set up a program that allows PTs to prescribe certain medications. The Army provides training, monitoring, physician review, and credentialing for PTs in specific areas of treatment (Schreck, 1999). The Army pharmacology training program is a model for the training of PTs in certain aspects of pharmacology.
In general, a PT may discuss a medication with a patient but cannot interpret information about medication use, because interpretation is beyond the physical therapy scope of practice. Physical therapists should only discuss medication issues that are within their scope of practice and within their scope of knowledge. Physical therapists should nevertheless be alert to adverse effects, contraindications, and abuse of OTC medications.
As with other health professionals, PTs have a duty to question any order, including medication orders that they believe is below the accepted standard of care or in violation of a hospital or employer policy or procedure. This includes drug or treatment orders that are illegible or unclear; PTs have a duty to request clarification from the doctor or practitioner who is responsible for the order.
During each client visit, PTs should complete a general assessment of the client, looking for any change in medical condition such as dehydration, fever, clammy skin, abnormal vital signs, or other gross signs that may indicate a change of condition, poor response to a treatment regimen, or the onset of a new medical problem. In some cases, an emerging medical problem may have been overlooked and vital medications withheld due to the lack of an appropriate diagnosis. Table 1 discusses common problems associated with medications in a variety of PT settings.
| TABLE 1 |
ISSUES RELATED TO MEDICATIONS IN PT SETTINGS |
| Setting |
Issues |
Common medications |
| Pediatrics |
Family education and issues related to pediatric dosing are common problems. |
Antispasticity, seizure, cardiac, pain and chemotherapy medications |
| Geriatrics and home health |
Under-medication and over-medication are both common, as are issues related to geriatric dosing.
Loss of muscle mass and body fat can significantly alter the absorption and metabolism of many common medications.
Poor communication can affect whether a medication is given or withheld.
Change of condition or transfer to a new setting can result in abrupt medication changes.
Polypharmacy can lead to adverse events such as falls.
Laxatives and stool softeners may affect activity levels.
Alcohol and recreational drugs may cause balance problems, swallowing problems and weakness.
Medications may be stopped or not taken as prescribed due to cost or inability to get to the pharmacy.
OTCs may be mixed with prescription medications.
Anticholinesterase drugs may cause fatigue, especially in people with disorders that affect muscle strength, such as post-polio syndrome. |
Cardiac medications,
antidepressants, narcotics,
OTCs,
alcohol, recreational
drugs, anticoagulants,
laxatives, stool softeners,
anticholinesterase drugs,
cough
medicines and
expectorants, antihistamines,
allergy and motion
sickness drugs |
| Outpatient and sports medicine |
Herbal medication interacting with prescribed medications.
Drug and alcohol abuse, recreational drugs.
Overuse of pain and anti-inflammatory medications.
Performance-enhancing drugs used by athletes can have a variety of physical effects.
Non-narcotic analgesics and over the counter (OTC) medications can cause drowsiness, weakness and fatigue and can mask the effects of overtraining. |
Anti-inflammatories,
narcotics, steroids,
herbal medications,
alcohol, recreational
drugs, anti-depressants |
| CASE 2 |
A PT employed in a nursing home was asked to evaluate a 78-year-old man admitted for confusion and falls. The man had been living at home with his wife but she was unable to continue providing the level of care needed. The patient was unable to walk and needed two people to assist with transfers.
During the evaluation the PT noted that the man had the classic signs of Parkinson's disease—resting tremor, bradykinesia, masked faces, and festinating gait. She documented her findings and reported the findings to the nursing and rehab staff. She called the primary physician and followed her call with a fax detailing her findings, which she carefully documented.
A week passed and neither the doctor nor the nursing staff had responded to her request for a review of the case. She repeated her findings to the director of nursing and called the primary physician a second time. She also discussed her findings with the family and tactfully suggested they call the physician and inquire on their own. Another week passed with no action from the physician or the facility.
After repeated attempts to contact the primary physician the PT learned that the physician "didn't feel comfortable" prescribing medication for Parkinson's because the client had seen by a neurologist 3 years before and there was no diagnosis of Parkinson's disease at that time. After 7 weeks of repeated attempts to get a diagnosis and treatment decision from the primary physician, the PT was finally able to persuade the director of nursing to obtain a prescription for the appropriate medication from the physician.
The client responded well to the new medication, showing documented improvement in all aspects of his daily activities and motor function, including gait.
Is this an example of a medical error? Would you consider the failure to prescribe appropriate medication an adverse event? Was a potentially beneficial service withheld? Did an error in diagnosis lead to the failure to apply timely treatment? What is the responsibility of the PT in this case? If she had failed to act on her findings would she be guilty of a medical error or negligence?
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Computerized Physician Order Entry
Systems-based analysis of medication errors and ADEs suggest that changes in the medication ordering system, including the introduction of computerized physician order entry (CPOE) with clinical decision support systems (CDSSs), may reduce medication-related errors (Making Healthcare Safer, 2001).
Computerized physician order entry automates the medication ordering process. Basic clinical decision support software may include suggestions or default values for drug doses, routes, and frequencies. More sophisticated software can perform drug allergy checks, drug laboratory value checks, and drug-drug interaction checks, in addition to providing reminders to the physician about drug guidelines or corollary orders at the time of ordering. More-powerful CDSS software can incorporate patient-specific information or pathogen-specific information, such as suggesting appropriate anti-infective regimens (Making Healthcare Safer, 2001).
High-Risk and High-Alert Medications
Physical therapists should be aware that certain medications are associated with adverse events. Published studies of ADEs have consistently identified certain classes of medications as particularly serious threats to patient safety. These "high-risk" medications include concentrated electrolyte solutions such as potassium chloride, intravenous insulin, chemotherapeutic agents, intravenous opiate analgesics, and anticoagulants such as heparin and warfarin (Making Healthcare Safer, 2001).
Heparin and warfarin are medications the use or misuse of which carry significant potential for injury, including thromboembolic complications in patients with atrial fibrillation or deep-vein thrombosis (DVT) and bleeding complications. These medications are commonly involved in ADEs for a variety of reasons, including the complexity of dosing and monitoring, patient compliance, numerous drug interactions, and dietary interactions that can affect drug levels (Making Healthcare Safer, 2001).
Individuals treated by physical therapists who may be at risk for venous thromboembolism and DVT include general-surgery, orthopedic, neurosurgery, and medical patients. Patients with total knee and hip replacements and hip fracture repairs are at risk for DVT. Several studies suggest that there may be a lack of awareness among practitioners about the potential for injury with these types of medications.
For institutions or groups attempting to improve appropriate use of measures to prevent venous thromboembolism, guidelines made available via computerized support systems or order sets provide the most effective means of implementing appropriate prophylaxis, especially when these systems are linked to effective educational programs (Making Healthcare Safer, 2001).
Pain Management
According to the AHRQ, untreated pain is a patient safety problem. At least 40 to 50 percent of postoperative patients have reported inadequate pain relief. The practice of withholding analgesics due to fear of masking symptoms and delaying diagnosis is still widespread in many emergency departments and other acute-care settings (Making Healthcare Safer, 2001).
There is increased interest in the use of nonpharmacologic interventions in conjunction with drugs to treat postoperative pain (Making Healthcare Safer, 2001). Physical therapists play a vital role in this area, although doctors and nurses may be unaware of their training and education in the nonpharmacologic treatment of pain. Physical therapists have a variety of tools and techniques at their disposal for the treatment of pain, including modalities such as electrical stimulation, heat, cryonics, ultrasound, manual therapy, positioning, and therapeutic exercise.
Medications in Non-Healthcare Settings
Many physical therapists work or consult in non-healthcare settings such as adult day care, summer camps, schools, group homes, board-and-care facilities, and jails. These facilities are usually licensed by the state but often use unlicensed staff members to dispense medications to clients. According to the National Coordinating Council for Medication Error Reporting and Prevention, medication errors are a significant problem in these settings.
The council recently published recommendations for the handling of medications (including OTC medications) in these settings. Recommendations includes proper storage, written policies and procedures, limitations on the type of medications stored by the organization, training programs, safeguards to prevent theft of controlled medications, and reporting and evaluation of medical errors. For more information go to http://www.nccmerp.org/council/council2003-06-20.html.
MEDICAL DOCUMENTATION AND COMMUNICATION
It is clear that good communication lies at the heart of good practice and thus underlies patient safety. Many errors have been demonstrated to arise from the lack of adequate or accurate communication. Meticulous medical documentation helps to prevent practice errors and provides a shield against errors arising from miscommunication.
Key Points in Good Documentation
Documentation must be credible and timely and must accurately reflect the patient's condition as well as the care given. Illegible writing, overuse of abbreviations, poor transfer of information (both within the department and when a patient transfers to another department) can cause medical errors. Therapists must learn and follow their facility's policies and procedures about charting.
If a practice error occurs, especially if it results in a lawsuit, good documentation is essential. In Reporting Risk Check-Up, Susan Abeln makes several key points about documentation:
- The documentation must be rendered accurately and clearly reflect the patient's condition, the care rendered to the patient and the patient's progress.
- Each therapist's documentation must be consistent with his or her own practices; the documentation of all providers in a department or clinic must be consistent.
- In general, more objective information in the record is better, assuming that everything included is factual and understandable.
- In all reporting, especially electronic reporting, confidentiality must be maintained and modifications in the record must be fully explained. (Abeln SH, 1999)
DOCUMENTATION CHECKLIST
- Document in the correct chart.
- Document any prevention measures including patient education.
- Write legibly, using agency-approved abbreviations.
- State the facts, not vague feelings.
- Be objective. Do not document personal opinions such as, "The patient is crazy" or "The patient seems angry."
- If you identify a problem, document the actions you took to address the problem.
- Document all communication with your colleagues and encourage them to document what they reported to you.
- Document only what you see, hear, feel, or smell.
- Document errors and how you dealt with the error.
- Document referrals to other health practitioners or services.
- If you document a patient symptom or complaint, also document what actions you took to address the problem.
- Never alter a patient record; follow your agency procedures for correcting a charting error.
- Document in a timely manner throughout your shift rather than waiting until the end of your shift.
- Do not pre-chart.
- Never document what someone else saw or heard unless the information is critical, in which case make sure you attribute the information within quotes.
REPORTING ERRORS
Improving client safety begins with prompt reporting of errors, followed by analysis of the root causes and contributing factors and development of a plan of action to prevent similar errors in the future. Only in this way can a healthcare organization assess the safety of care delivered and determine 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, negatively 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 ten- to twenty-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 Commission on Accreditation of Healthcare Organizations (JCAHO), 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's becoming aware of the sentinel event
The 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 4.
| BOX 4 |
JCAHO REPORTABLE SENTINEL EVENTS |
|
The Joint Commission encourages, but does not require, reporting of any sentinel event meeting the criteria below.
Unanticipated death or major permanent loss of function, unrelated to the natural course of the client's illness or underlying condition, or one of the following (even if the outcome was not death or major permanent loss of function unrelated to the natural course of the client's illness or underlying condition):
- Suicide of any individual receiving care, treatment, or services in a staffed around-the-clock care setting or within 72 hours of discharge
- Unanticipated death of a full-term infant
- Abduction of any individual receiving care, treatment, or services
- Discharge of an infant to the wrong family
- Rape
- Hemolytic transfusion reaction involving administration of blood or blood products having major blood group incompatibilities
- Surgery on the wrong individual or wrong body part
- Unintended retention of a foreign object in an individual after surgery or other procedure
- Severe neonatal hyperbilirubinemia (bilirubin >30 milligrams/deciliter)
- Prolonged fluoroscopy with cumulative dose >1500 rads to a single field, or any delivery of radiotherapy to the wrong body region or >25% above the planned radiotherapy dose
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Accredited facilities are to report not only actual but also potential sentinel events, the close calls and near misses that afford valuable learning opportunities for prevention of future errors. Once sentinel events are reported, the JCAHO requires 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 client safety. Says the JCAHO:
Since 1995 JCAHO has reviewed 3,197 sentinel events. Of these, the most common are client suicide, operative/postoperative complications, wrong-site surgery, and medication errors. The JCAHO publishes an online newsletter, Sentinel Event Alert, which identifies events, describes their common 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 and ambulatory surgery center implement a risk-management program with state oversight and an internal incident-reporting system. State oversight is provided by the Florida Agency for Healthcare 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 healthcare 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:
- 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 neurologic, 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 client has not given his or her informed consent, or
- Any condition that required the transfer of the client, within or outside the facility, to a unit providing a more acute level of care due to the adverse incident, rather than the client's condition prior to the adverse incident;
- Was the performance of a surgical procedure on the wrong client, a wrong surgical procedure, a wrong-side surgical procedure, or a surgical procedure otherwise unrelated to the client's diagnosis or medical condition;
- Required the surgical repair of damage resulting to a client from a planned surgical procedure, where the damage was not a recognized specific risk, as disclosed to the client and documented through the informed-consent process; or
- Was a procedure to remove unplanned foreign objects remaining from a surgical procedure. (F.S.395.0197)
The risk-management reporting system must:
- Investigate and analyze the frequency and causes of adverse incidents to clients
- Educate facility staff and agents
- Analyze client 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.
In addition to their internal reporting system, Florida hospitals and ambulatory surgical centers also must submit two types of reports to the Florida AHCA:
- Code 15 reports, which report in detail on each serious client 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 clients. 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.
- The annual report, which includes all adverse incidents that occur in the facility and malpractice actions (new, pending, and closed) in the course of a calendar year. Facilities are also required to report any injuries of which they are aware that occur through any healthcare service, including nursing homes, home health organizations, doctors' offices, dentists' offices, or any other purveyor of healthcare service. Florida Statute 641.55 requires similar reporting of client injury incidents by HMOs. These reports are due after the first of each year for the previous year.
Florida law (F.S. 395.051) also requires that hospitals and other healthcare facilities notify each client—or an individual identified pursuant to s.765.401(1)—in person about adverse incidents that result in serious harm to the client. "Notification of outcomes of care that result in harm to the client under this section shall not constitute an acknowledgment or admission of liability, nor can it be introduced as evidence."
NURSES AS COLLEAGUES IN PATIENT SAFETY ISSUES
Although this course is written for physical therapists it is impossible to discuss medical errors without discussing the vital role that nurses play in analyzing and managing risk factors in healthcare settings. Nurses account for the largest segment of the healthcare workforce at just over 3,000,000 nationwide and are an excellent and often underutilized resource for physical therapists for issues related to medications, workplace practices, patient safety, and staff education.
The American Nurses Association (ANA) has been a vocal advocate of improved patient safety practices and has led the fight to improve patient safety. Echoing the IOM report, the ANA has described the "unholy trinity" of "patient injuries and health care errors, staffing shortages, and the looming nursing shortage" as a major factor in the ability of nurses to provide consistently safe care.
The ANA describes a workplace environment in which nurses are "stressed, fatigued, and unable to use their critical thinking skills, predisposed to workplace-related accidents, illnesses and injuries, and involved in incidents of medication errors and episodes of failure to rescue" (Ballard, 2003).
Research has shown that adverse events are reduced when nurse staffing levels were higher. One study reported that an increase in the number of direct patient-care hours by a registered nurse was associated with improved patient outcomes (Ballard, 2003). Other studies have shown a correlation between increased workloads and patient death and, conversely, a reduction in adverse events when the number of nurses was increased by 10 percent (Ballard, 2003).
A study by the American Nurses Credentialing Center (ANCC, a division of the ANA) is of particular interest to physical therapists considering specialty certification. The ANCC reported that nurses who receive specialty certification reported the following:
- Greater confidence in practice and decision-making
- More confidence in detecting complications
- Improved collaboration and communication with other health practitioners
- Fewer adverse events and errors in patient care (Ballard, 2003)
MOVING BEYOND BLAME: IMPROVING CLIENT OUTCOMES
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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
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Traditionally, healthcare has operated on a "culture of blame." One of the common tools for redress in a culture of blame is the lawsuit. The fear of being sued presumably leads to more careful and safer behavior by health professionals. But neither studies nor anecdotal evidence bear this out. This may be, in part, because analysis of medical lawsuits shows that "not only do many patients sue when negligence has not occurred; most victims of negligence do not sue" (Keepnews & Mitchell, 2003).
Within a medical organization, medical errors are recorded on an incident report. But, because reporting of medical errors has traditionally focused on the identification and punishment of individual health professionals, there is a huge disincentive for reporting. Filing an incident report is time-consuming, frustrating, and often ineffective. "Evidence suggests that such internal reporting systems have resulted in significant under-reporting of errors, frustrating efforts to gain an accurate picture of error rates and/or to gauge the effectiveness of error prevention efforts" (Keepnews & Mitchell, 2003). Any health practitioner who has reported errors or filed incident reports is aware that in many cases no action is taken.
One of the main goals of the organizations working to improve patient safety is to encourage the creation of a "culture of safety" in which medical errors are discussed openly and addressed thoroughly. When an organization values safety this commitment is evident throughout the organization from top management to the bedside. A culture of safety includes:
- Acknowledgment of the high risk, error-prone nature of an organization's activities.
- Creation of a blame-free environment where individuals are able to report errors or close calls without punishment.
- Expectation of collaboration across ranks to seek solutions to vulnerabilities.
- Willingness on the part of the organization to direct resources to address safety concerns. (Making Healthcare Safer, 2001)
| CASE 3 |
A staff PT was asked to treat several patients at a nursing home some distance from her home facility. Many of the residents had Alzheimer's disease or dementia and needed assistance with most activities.
On August 11, 2001, the temperature outside hit an unpleasant 112°F. The nursing home was air-conditioned and the temperature inside maintained at 70°F. At 9 a.m. the air conditioning malfunctioned in the dayroom, the area where residents gather for lunch each day. The day room is a large L-shaped room with east-facing floor-to-ceiling windows covered by long, closed curtains.
As the PT was finishing her treatments before lunch she assisted a demented patient to the dayroom, which was filled with dozens of elderly residents waiting for lunch. As she passed from the air-conditioned hallway into the dayroom, she was hit by a wall of stifling hot air. She placed the patient at a nearby table then quickly returned to the comfort of the air-conditioned hallway.
The PT felt a moment of guilt—the residents looked hot and some of them were slumped over, red-faced, and sweating. She mentioned the broken air conditioner and the heat to her supervisor, a speech therapist, who told her not to worry and not to "rock the boat."
A few minutes later the PT assisted a second resident to the dayroom and placed him at a table near the back of the room. She glanced around the corner and noticed 6 or 8 residents in the very back of the room slumped over with their heads on the table. She asked them if they were okay and opened a window but the air outside was even hotter than inside and she quickly closed it. She left the room and went to her supervisor again and was told her to "leave the situation alone," "don't antagonize the nurses" and to go lunch.
Instead, she began gathering fans from around the facility and placed them in the dayroom to try to cool the residents. Most of the administrative staff were at lunch, leaving only a few nursing assistants to care for the overheated residents. The charge nurses were charting at desks some distance from the dayroom. By the time the PT left for lunch she and one of the nursing assistants had placed several fans around the dayroom and she felt confident that the residents were out of danger.
When she returned from lunch the dayroom was empty and she returned the fans to their previous locations. A few minutes later the facility administrator stopped her in the hallway and said in a loud voice that the charge nurse had filed a complaint against her for "stealing my fans." She continued to berate the PT in a loud voice in the middle of the busy hallway. The PT asked to continue their discussion in a more private setting and they adjourned to the administrator's office.
The administrator criticized her for "interfering" and for refusing to leave the fan at the nurses' station before lunch. She asked the PT to leave the facility immediately, despite the fact that the PT had not completed her treatments for the day. The PT left and took no further action. As she departed the therapy room her supervisor looked away and said, "I'm sorry, but you shouldn't have taken the fans. This is the second time you've complained about a patient care issue and the administrator thinks you're not a team player." The dayroom air conditioning was not fixed the next day and the entire incident was repeated.
Was the PT interfering? What was her responsibility in this situation? Should she have reported this incident to the State Department of Health or the local police? Should she have filed an incident report? If a patient had died from the heat would the PT have been liable despite her attempts to intervene? Is this an example of a system breakdown or is the PT simply meddling in a nursing matter? Is this an example of a culture of poor safety?
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Root Cause Analysis (RCA)
The JCAHO requires that a thorough, credible root cause analysis (RCA) and corrective action plan be performed for each reported sentinel event within 45 days of the event's occurrence or of the organization's becoming aware of the event. According to JCAHO research, the leading root causes of sentinel events between 1996 and 2004 were communication, orientation/training, client assessment, and staffing. The U.S. Department of Veterans Affairs, National Center for Client Safety, offers the following guidance.
Root Cause Analysis
The goal of a root cause analysis (RCA) is to find out:
- What happened
- Why it happened
- What to do to prevent it from happening again
Root cause analysis is a tool for identifying prevention strategies. It is a process that is part of the effort to build a culture of safety and move beyond the culture of blame.
In RCA, basic and contributing causes are discovered in a process similar to diagnosis of disease—with the goal always in mind of preventing recurrence.
Root cause analysis is:
- Interdisciplinary, involving experts from the frontline services
- Involving of those who are the most familiar with the situation
- Continually digging deeper by asking why, why, why at each level of cause and effect
- A process that identifies changes that need to be made to systems
- A process that is as impartial as possible
To be thorough, an 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
To be credible, an 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. (U.S. Dept. Veterans Affairs, 2005)
Electronic medical records (EMRs) and other information technology can improve communication and client safety if fully implemented in hospitals and other healthcare facilities. For example, EMRs can help reduce medication errors, avoid the need to repeat laboratory tests, and improve continuity of care across the healthcare system. All healthcare providers within a system have access to accurate and complete information when they need it.
One barrier to adoption of EMRs is the cost. According to the Leapfrog Group, a national coalition of large healthcare providers, a purchase and implementation of EMRs in a 200-bed hospital can cost from $1 to $7 million. However, the return on investment in terms of increased efficiency and improved client safety can be substantial (Joint Commission, 2005).
One of the largest HMOs, Kaiser Permanente, which serves 3.2 million people in Northern California, has implemented a sophisticated EMR system to help improve client safety and quality of care. Every doctor in every Kaiser hospital, clinic, and ambulatory care center has instant access to each of their client's charts.
According to Robert Pearl, the Executive Director and CEO of Kaiser Permanente, the use of EMRs has helped reduce the death rate from heart disease among Kaiser members 30% below the rate in the general population, adjusted for age and sex (Pearl, 2005).
The JCAHO issued new mandatory goals and recommendations to improve client safety that take effect in January 2006. 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 2006 National Client Safety Goals and Recommendations are summarized in Box 5. New goals are in boldface type.
| BOX 5 |
2006 JCAHO NATIONAL SAFETY GOALS |
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Goal 1. Improve the accuracy of client identification.
Recommendations:
- Use at least two client identifiers (neither of which is the client's room number) whenever administering medications or blood products. Taking blood samples or other specimens for clinical testing, or providing any other treatments or procedures.
Goal 2. Improve the effectiveness of communication among caregivers.
Recommendations:
- For verbal or telephone orders or for telephonic reporting of critical test results, verify the complete order or test result by having the person receiving the order or test result "read-back" the complete order or test result.
- Standardize a list of abbreviations, acronyms and symbols that are not to be used throughout the organization.
- Measure, assess and, if appropriate, take action to improve the timeliness of reporting, and the timeliness of receipt by the responsible licensed caregiver, of critical test results and values.
- Implement a standardized approach to "hand off" communications, including an opportunity to ask and respond to questions.
Goal 3. Improve the safety of using medications.
- Standardize and limit the number of drug concentrations available in the organization.
- Identify and, at a minimum, annually review a list of look-alike/sound-alike drugs used in the organization, and take action to prevent errors involving the interchange of these drugs.
- Label all medications, medication containers (eg, syringes, medicine cups, basins), or other solutions on and off the sterile field in perioperative and other procedural settings.
Goal 4. Not applicable
Goal 5. Retired in 2006
Goal 6. Not applicable
Goal 7. Reduce the risk of healthcare-associated infections.
- Comply with current CDC hand hygiene guidelines.
- Manage as sentinel events all identified cases of unanticipated death or major permanent loss of function associated with a healthcare-associated infection.
Goal 8. Accurately and completely reconcile medications across the continuum of care.
- Implement a process for obtaining and documenting a complete list of the client's current medications upon the client's admission to the organization and with the involvement of the client. This process includes a comparison of the medications the organization provides to those on the list.
- A complete list of the client's medications is communicated to the next provider of service when a client is referred to or transferred to another setting, service, practitioner or level of care within or outside the organization.
Goal 9. Reduce the risk of client harm resulting from falls.
- Implement a fall reduction program and evaluate the effectiveness of the program.
Goal 10. Not applicable
Goal 11. Not applicable
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In July 2001 the Agency for Healthcare Research and Quality released a report outlining evidenced-based clinical recommendations for improving client safety. Titled Making Healthcare Safer: A Critical Analysis of Client Safety Practices, the report reviews 79 practices to prevent adverse events and improve client safety, based on current research. The eleven most highly rated practices are listed in Box 6. 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 (Shojania et al., 2001). For a summary of the AHRQ report, go to http://www.ahrq.gov/clinic/ptsafety/summary.htm.
| BOX 6 |
CLINICAL OPPORTUNITIES FOR SAFETY IMPROVEMENT |
- Appropriate use of prophylaxis to prevent venous thromboembolism in clients at risk
- Use of perioperative beta-blockers in appropriate clients to prevent perioperative morbidity and mortality
- Use of maximum sterile barriers while placing central intravenous catheters to prevent infections
- Appropriate use of antibiotic prophylaxis in surgical clients to prevent perioperative infections
- Asking that clients recall and restate what they have been told during the informed consent process
- Continuous aspiration of subglottic secretions (CASS) to prevent ventilator-associated pneumonia
- Use of pressure-relieving bedding materials to prevent pressure ulcers
- Use of real-time ultrasound guidance during central-line insertion to prevent complications
- Client self-management for warfarin (Coumadin) to achieve appropriate outpatient anticoagulation and prevent complications
- Appropriate provision of nutrition, with a particular emphasis on early enteral nutrition in critically ill and surgical clients
- Use of antibiotic-impregnated central-venous catheters to prevent catheter-related infections
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To speed the most urgent improvements in client safety, the Institute for Healthcare Improvement (IHI), a nonprofit organization headquartered in Cambridge, Massachusetts, launched the 100,000 Lives campaign in December 2004. The American Medical Association, the American Nurses Association, and JCAHO signed on as collaborators together with four government agencies: the Centers for Disease Control and Prevention, the Centers for Medicare and Medicaid Services, the Veterans Health Administration, and AHRQ.
This campaign focuses on six basic measures that could save as many as 100,000 lives each year if even 2,000 hospitals adopted them. The good news is that nearly 3,000 hospitals have enrolled in this campaign in its first year (IHI, 2005).
The six measures of the campaign are based on the best practices from AHRQ's Making Healthcare Safer report and include:
- Prevention of ventilator-associated pneumonia
- Prevention of central-line infections
- Prevention of surgical-site infections
- Deployment of rapid-response teams*
- Assurance of optimal care for clients with acute myocardial infarction
- Prevention of adverse drug events
Institute for Health Improvement CEO Donald M. Berwick explained in a Newsweek editorial:
In 2005, JCAHO released a white paper entitled Healthcare at the Crossroads: Strategies for Improving the Medical Liability System and Preventing Client Injury. This report outlines a public policy action plan based on three broad recommendations:
- Pursue client safety initiatives that prevent medical injury.
- Promote open communication between clients and practitioners.
- Create an injury compensation that is client-centered and serves the common good. (JCAHO, 2005)
While systems changes move slowly, healthcare providers can be change agents in their own department and facility. As an advocate for clients, each provider can make a difference. As Leape and Berwick (2005) wrote:
Public Education Measures Related to Client Safety
Making the client and the family part of the healthcare team is an important strategy in improving client safety and reducing medical errors. Several organizations have materials available to educate clients about their role on the healthcare team. The AHRQ has developed a simple message for clients called Five Steps to Safer Healthcare, as well a comprehensive patient fact sheet that hospitals are encouraged to make available to clients.
The single most important way clients can help to prevent errors is to be an active members of the healthcare team. That means taking part in every decision about their healthcare. Research shows that clients who are personally involved with their care tend to get better results. Some specific tips, based on the latest scientific evidence about what works best, are listed in Box 7.
| BOX 7 |
TIPS TO HELP PREVENT MEDICAL ERRORS |
Medicines
- Make sure that all of your doctors know about everything you are taking. This includes prescription and over-the-counter medicines, and dietary supplements such as vitamins and herbs.
- At least once a year, bring all of your medicines and supplements with you to your doctor. "Brown bagging" your medicines can help you and your doctor talk about them and find out if there are any problems. It can also help your doctor keep your records up to date, which can help you get better quality care.
- Make sure your doctor knows about any allergies and adverse reactions you have had to medicines. This can help you avoid getting a medicine that can harm you.
- When your doctor writes you a prescription, make sure you can read it. If you can't read your doctor's handwriting, your pharmacist might not be able to either.
- Ask for information about your medicines in terms you can understand—both when your medicines are prescribed and when you receive them. What is the medicine for? How am I supposed to take it, and for how long? What side effects are likely? What do I do if they occur? Is this medicine safe to take with other medicines or dietary supplements I am taking? What food, drink, or activities should I avoid while taking this medicine?
- When you pick up your medicine from the pharmacy, ask: Is this the medicine that my doctor prescribed? A study by the Massachusetts College of Pharmacy and Allied Health Sciences found that 88% of medicine errors involved the wrong drug or the wrong dose.
- If you have any questions about the directions on your medicine labels, ask. Medicine labels can be hard to understand. For example, ask if "four doses daily" means taking a dose every 6 hours around the clock or just during regular waking hours.
- Ask your pharmacist for the best device to measure your liquid medicine. Also, ask questions if you're not sure how to use it. Research shows that many people do not understand the right way to measure liquid medicines. For example, many use household teaspoons, which often do not hold a true teaspoon of liquid. Special devices, like marked syringes, help people to measure the right dose. Being told how to use the devices helps even more.
- Ask for written information about the side effects your medicine could cause. If you know what might happen, you will be better prepared if it does—or, if something unexpected happens instead. That way, you can report the problem right away and get help before it gets worse. A study found that written information about medicines can help clients recognize problem side effects and then give that information to their doctor or pharmacist.
Hospital Stays
- If you have a choice, choose a hospital at which many clients have the procedure or surgery you need. Research shows that clients tend to have better results when they are treated in hospitals that have a great deal of experience with their condition.
- If you are in a hospital, consider asking all healthcare workers who have direct contact with you whether they have washed their hands. Handwashing is an important way to prevent the spread of infections in hospitals. Yet, it is not done regularly or thoroughly enough. A recent study found that when clients checked whether healthcare workers washed their hands, the workers washed their hands more often and used more soap.
- When you are being discharged from the hospital, ask your doctor to explain the treatment plan you will use at home. This includes learning about your medicines and finding out when you can get back to your regular activities. Research shows that at discharge time doctors think their clients understand more than they really do about what they should or should not do when they return home.
Surgery
- If you are having surgery, make sure that you, your doctor, and your surgeon all agree and are clear on exactly what will be done. Doing surgery at the wrong site (for example, operating on the left knee instead of the right) is rare. But even once is too often. The good news is that wrong-site surgery is 100% preventable. The American Academy of Orthopedic Surgeons urges its members to sign their initials directly on the site to be operated on before the surgery.
Other Steps You Can Take
- Speak up if you have questions or concerns. You have a right to question anyone who is involved with your care.
- Make sure that someone, such as your personal doctor, is in charge of your care. This is especially important if you have many health problems or are in a hospital.
- Make sure that all health professionals involved in your care have important health information about you. Do not assume that everyone knows everything they need to.
- Ask a family member or friend to be there with you and to be your advocate (someone who can help get things done and speak up for you if you can't). Even if you think you don't need help now, you might need it later.
- Know that "more" is not always better. It is a good idea to find out why a test or treatment is needed and how it can help you. You could be better off without it.
- If you have a test, don't assume that no news is good news. Ask about the results.
- Learn about your condition and treatments by asking your doctor and nurse and by using other reliable sources.
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Infants and children are at greatest risk of harm from medical errors, so it is essential that parents be well informed about how to reduce the risk of medical errors in their children's healthcare. Box 8 explains what parents can do to ensure their child's safety and quality of care.
| BOX 8 |
TIPS FOR PARENTS: PREVENTING MEDICATION ERRORS |
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While medication errors can happen to any client at any age, the consequences may be far more devastating when children are involved. With this in mind, USP offers parents the following tips to help prevent medication errors from happening to their children:
- On admittance to the hospital, provide the healthcare practitioner (HCP) with an up-to-date list of all medicines (prescription and over-the-counter) and dietary supplements that your child is taking. This will help minimize medication errors and prevent drug interactions during your child's hospital stay.
- Make sure your child's HCP is aware of any allergies your child may have. For life-threatening allergies, be sure that your child wears a MedicAlert bracelet at all times.
- Medications administered to children are based on the child's weight in kilograms. For purposes of preparing appropriate dosages of medicines, your child's weight in pounds must be divided by 2.2 to convert it into kilograms. Be aware of this calculation and/or your child's weight in kilograms, and reconfirm the correct dosage with your child's HCP if you have concerns.
- Be sure that you are provided with verbal and written information about your child's medications, the common side effects, and the adverse events that should be reported to your child's HCP.
- Pay close attention to how your child is feeling while in the hospital. Notify the HCP immediately if you notice any negative side effects from the administered medications, such as sudden difficulty in swallowing or breathing.
- If your child is given a liquid medication to take after release from the hospital, be sure you are provided with an appropriate measuring device and instructions to ensure proper medication doses.
- In case of an emergency, be sure that your child's school has a list of any medical conditions or allergies your child may have.
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Posted March 20, 2006
Expires December 31, 2008
Copyright © 2003, 2006 Wild Iris Medical Education. All rights reserved.
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