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Medical Errors

Author: Julia Tortorice

 

Medical Errors | Copyright © 2013 CEUFast.com


Course Contents

   Purpose
   Objectives
   Overview
   Competency
   Performance Improvement (PI)
   High Reliability
   Quality Control
   Risk Management
   Sentinel Events
   Root Cause Analysis
   Human Error
   Human Factors Engineering
   The Cognitive Process
   Impact of Design
   Interactions with Others
   Applying Human Factors Science to
     Healthcare

   Medication Errors
   High-Alert Medications
   Anticoagulants
   Pediatric Medication
   Infusion Pump Errors
   Medication Reconciliation
   Disruptive Behavior
   Tubing Misconnection
   Technology
   Medical Device Alarm Safety
   National Patient Safety Goals
   Conclusion
   References

   Click any section in the index above to browse to the corresponding course section 

 

Purpose

The purpose of this course is to enable the learner to understand and apply principle of process improvement, the influence of human factors in errors, how to identify situations where errors commonly occur, and how to apply strategies for prevention.

 

Objectives

After completing this course, the learner will be able to:

1. Discuss programs to reduce medical errors,
   
2. Define Sentinel Event,
   
3. Define Root Cause Analysis,
   
4. Discuss human factors involvement in medical errors, and
   
5. Discuss methods to avoid medical errors.

 

Overview

Over the past fifty years, a variety of approaches have been tried to reduce medical errors, with only limited success (Chassin, 2011). "The Institute of Medicine estimates that, on average, hospitalized patients are subject to at least one medication error per day (Radley, et.al. 2013, pg. 2)." Based on literature review, deaths associated with preventable harm to patients were estimated at more than 400,000 per year (James, 2013). John James, PhD (2013. Pg. 2) president of the Joint Commission, feels the following are the contributing factors to preventable medical errors:

  Medical care in the United States is technically complex at the individual provider level, at the system level, and at the national level. The amount of new knowledge generated each year by clinical research that applies directly to patient care can easily overwhelm the individual physician trying to optimize the care of his patients. Furthermore, the lack of a well-integrated and comprehensive continuing education system in the health professions is a major contributing factor to knowledge and performance deficiencies at the individual and system level. Guidelines for physicians to optimize patient care are quickly out of date and can be biased by those who write the guidelines. At the system level, hospitals struggle with staffing issues, making suitable technology available for patient care, and executing effective handoffs between shifts and also between inpatient and outpatient care. Increased production demands in cost-driven institutions may increase the risk of preventable adverse events (PAEs). The United States trails behind other developed nations in implementing electronic medical records for its citizens. Hence, the information a physician needs to optimize care of a patient is often unavailable.

At the national level, our country is distinguished for its patchwork of medical care subsystems that can require patients to bounce around in a complex maze of providers as they seek effective and affordable care. Because of increased production demands, providers may be expected to give care in suboptimal working conditions, with decreased staff, and a shortage of physicians, which leads to fatigue and burnout. It should be no surprise that PAEs that harm patients are frighteningly common in this highly technical, rapidly changing, and poorly integrated industry.

Medical errors increase expenses in additional patient care and in litigation. Serious medical errors are devastating to the patient, family, and staff.

The severe consequence of medical errors is one reason that healthcare is a highly regulated business. All healthcare organizations have to be licensed. They also have to meet industry standards, building and safety codes, Federal statutes, and state statutes.

Healthcare organizations are subject to inspection for compliance with statutes, regulations, and industry standards. Inspections can be scheduled or unscheduled. Scheduled inspections are conducted periodically. Unscheduled inspections can be conducted randomly, or they can be conducted for cause, like a patient complaint. One of the most well know inspection agencies for hospitals, is the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). It is an independent organization, meaning that JCAHO is neither a government agency, nor does it have a financial interested in any healthcare organization. If a healthcare organization meets industry standards, JCAHO accredits that organization.

 

Competency

Healthcare organizations must determine an individual's qualifications and ability to do the job. This involves checking education, license, experience, and credentials before an employee is hired. At least annually, staff performance is evaluated. Competency, continued licensure, and continuing education should also be checked at least annually. For licensed independent practitioners, like physicians and nurse practitioners, that process is called credentialing and privileging.

 

Performance Improvement (PI)

Healthcare organizations have ongoing programs to identify, correct and prevent medical errors. PI is a way to systematically monitor, analyze, and improve an organization’s performance and outcomes. PI should improve an organization’s performance by reducing factors that contribute to unanticipated adverse events and outcomes. Unanticipated adverse events and outcomes can be caused by poorly designed systems, system failures, or errors. Decreasing unanticipated adverse events and outcomes requires an environment where patients, families, staff, and leaders can identify and manage risks to safety. Such an environment encourages the following:

  Recognizing and acknowledging risks and unanticipated adverse events
   
  Initiating actions to reduce these risks and unanticipated adverse events
   
  Reporting internally on risk reduction initiatives and their effectiveness
   
  Focusing on processes and systems
   
  Minimizing individual blame or retribution for involvement in an unanticipated adverse event
   
  Investigating factors that contribute to unanticipated adverse events and sharing that acquired knowledge both internally and with other hospitals

The following are other concepts related to PI. Continuous Quality Improvement (CQI) is an approach that ensures that organizations always look for ways to improve processes and practices. Total Quality Management (TQM) is a management system that encompasses quality planning, quality control, and quality improvement. Six Sigma, lean management, and change management are performance improvement methodologies that are a systematic approach to dissecting complex safety problems and implementation of effective solution (Chassin, 2011).
These programs are slightly different from PI, but you may hear the terms used interchangeably.

 

High Reliability

High Reliability is an ongoing quality improvement process that is used in highly technical industries where there is a high risk. The concept of high reliability involves a safety culture of collective mindfulness that everyone who works in these organizations is acutely aware that even small failures in safety protocols or processes can lead to catastrophic adverse outcomes. Therefore, everyone in these organizations is always searching for the smallest indication that the environment or a key safety process has changed in some way that might lead to failure (Chassin, 2011). Once a deficiency is identified, it is eliminated by improving the processes. There are three Requirements for Achieving High Reliability:

  Leadership
   
  Safety Culture
   
  Robust Process Improvement

 

Quality Control

Quality Control (QC) is an ongoing, systematic measurement to determine compliance and accuracy. It is required for some equipment or measurement tests. Examples are checking the high and low control limits on a glucometer or the temperature of the medication refrigerator. QC is often a component of, or is mentioned in relationship to PI.

 

Risk Management

Risk Management (RM) is a program that is focused on eliminating or minimizing the effects of accidental losses to an organization. RM works closely with and sometimes overlaps functions with PI. The Risk Managers are involved with risk financing, through insurance companies to minimize financial losses. They usually investigate serious medical errors, institute damage control, and consult with legal council as needed.

Incident reports are an important source of information for a Risk Manager. Aggregate data from incident reports is statistically analyzed to identify areas of risk and exposure. Risk control techniques are then applied to those areas of focus. The usual techniques are avoidance, transfer, prevention, reduction, segregation, and duplication.

Avoidance is a technique that eliminates the possibility of a loss. This is also known as a forcing function. This technique involves designing equipment or processes to make it impossible to use it incorrectly. Examples are stocking only one concentration of a medication or removing concentrated Potassium Chloride from floor stock. These functions are effective, but can be inconvenient and time consuming for personnel.

Transfer is the process of negotiating with insurance companies to transfer the financial burden of a loss. This technique assumes that the loss cannot be prevented so we must be insured against those times when it happens.

Loss prevention reduces the probability or frequency of a loss but does not eliminate the chance of loss, nor does it reduce the severity of that loss. This is also known as a constraint function. This means that equipment or a process is designed to make it difficult to use it incorrectly. Examples are limiting floor stock or a policy limiting verbal orders. Constraints can help prevent errors that might be made by less experienced or distracted personnel.

Loss reduction focuses on reducing the severity of damage. For example, frequent monitoring instituted for conscious sedation procedures does not reduce the risk of the sedation being too deep. However, it allows early intervention to reverse the sedation and provide adequate oxygenation.

Segregation means that a process is totally separated from the rest of a clinical setting to reduce or eliminate errors. For example, changing the medication administration system so the pharmacist fills the order and administers the medication to a patient. This eliminates the potential error at the point the pharmacy usually hands off the medication to nursing. However, as with most segregation techniques, it is too expensive and impractical.

Duplication means that there is a backup. For instance, having employees cross-trained. That way, someone is available to perform a job when the person who normally performs that job is unexpectedly unavailable.

 

Sentinel Events

JCAHO (2007, pg 1) defines a sentinel event as:

  Sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase "or the risk thereof" includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome.
   
  Such events are called "sentinel" because they signal the need for immediate investigation and response.
   
  The terms "sentinel event" and "medical error" are not synonymous; not all sentinel events occur because of an error and not all errors result in sentinel events.

The following events are considered a sentinel event, even if the outcome is not death or major permanent loss of function: suicide; unanticipated death of a full term infant; infant abduction or discharge to the wrong family; rape; hemolytic transfusion reaction; and surgery on the wrong patient or wrong body part (JCAHO, 2007). A near miss is a potential error that fails to cause injury by chance or because it is stopped before it occurs. The natural course of the patient's illness or underlying condition is not considered a sentinel event.

JCAHO requires accredited organizations to identify and respond appropriately to sentinel events. Appropriate response includes conducting a timely and thorough investigation, implementing improvements to reduce risk, and monitoring the effectiveness of the improvements. Healthcare organizations are encouraged to report sentinel events to JCAHO. The information from these reports is evaluated and published in the Sentinel Event Alert. It includes aggregate data, specific examples, and strategies for prevention. The Sentinel Event Alert is available on the Internet here.

 

Root Cause Analysis

JCAHO requires use of root cause analysis (RCA) to investigate the processes and systems that contribute to a sentinel event. RCA is a tool that helps identify and clarify the bottom line factors that precipitate an error or near miss. RCA focuses on systems and processes, not on individual performance.

The RCA process repeatedly digs deeper into an issue by asking "Why" questions until no additional logical answers can be identified. A team of people representing the areas that are involved in an event is brought together to do this analysis. The team begins with a standardized template called an Ishikawa diagram. (Figure 1) This template is also known as a fish bone diagram or cause and effect diagram.

  
 


Figure 1, Ishikawa Diagram. The major headings are suggested and can be changed.

The team selects major headings for the diagram that will include categories of possible causes. The headings should be as independent from each other as possible to avoid confusion. The team identifies the potential factors that would cause the problem. These are written along the major branches of the diagram. For each cause listed, the team asks "why?" Those reasons are written down as smaller branches on the diagram. The rule of thumb is to ask "why" five times. When you reach a point where there is no additional logical answer to the question "why," you have reached what is called a root cause.

Once the Ishikawa diagram is complete, the underlying causes of the event are summarized. Changes that could be made in systems and processes that would reduce the risk of similar adverse events are suggested.

One type of cause is special cause found in clinical processes. Special cause is a factor that is intermittently and unpredictably. This causes a variation that is not inherent in the system. An example is a patient has an allergic reaction to a medication that they have successfully taken in the past. The other type of cause is common cause in organization’s process. Common cause is a factor that results from variation that is inherent in the process or system. RCA seeks to identify potential areas for improvement in a process or system that might help reduce the risk of occurrence of an event. An example is allowing only premixed Potassium Chloride solutions on the nursing unit will prevent the possibility of making an error in the dilution.

RCA has a limitation, which is known as the blinder effect. That is the tendency for the team to look only at one part of the process that led to the event, instead of the entire process.

 

Human Error

By nature, humans are fallible. It is unreasonable to expect error-free performance by humans. Human beings have limited mental and information-processing capabilities. Excessive levels of stress or fatigue have a negative impact on performance (ACSQC, 2004).

Every day we all face thousands of interactions with machines, systems, and each other. The vast majority of those interactions goes smoothly and unnoticed. A few interactions that force us to work outside of routine and intuition are simple annoyances with which we have learned to live. Occasionally, one of those interactions leads to an unintended result, an error. While humans can rapidly adapt to impediments blocking their path, and develop compensatory workarounds, these short-term solutions often introduce new risks. Human factors science offers better understanding of the causes of errors, the workarounds already in place, and solutions which are less likely to have negative, unintended consequences.

Human error has been implicated in 60 to 80 percent of accidents that occur in complex systems. Accidents due solely to environmental and mechanical factors have been greatly reduced over the last several years; however, those attributable to human error continue to be a problem.

Healthcare has traditionally regarded error as a moral failing. This places an unsustainable burden of perfection on clinicians (ACSQC, 2004). This attitude impedes efforts to identify errors their frequency, their effects, and how to best protect patients (ACSQC, 2004).

Solutions reached by trial and error or workarounds might simply shift the risk elsewhere. While "fixed by common sense" may often be sufficient, common sense can also benefit from science and engineering.

Human factors science discovers and applies information about human behavior, abilities, limitations, and other characteristics to the design of tools, machines, systems, tasks, jobs, and environments for productive, safe, comfortable, and effective human use. Human factors science is not just applying checklists and guidelines, not just using oneself as the model for designing things, and it is not just common sense.

 

Human Factors Engineering

Human factors engineering uses systems analysis. Humans are considered a critical system component. Human factors analysis focuses on human operators to determine what they are required to do. It combines the scientific methodology familiar to clinicians to explore the causes of error with an engineering approach of task analysis. Human factors analysis goes further than Root Cause Analysis (RCA). This methodology includes:

  Systematic observation of procedures
   
  Interviews and focus groups
   
  Activity recording and charting
   
  Analysis of fatigue and distraction factors
   
  Analysis of information flow
   
  Developing and testing models of expected effectiveness

British Psychologist Professor James Reason (1990) developed a model of human error based on the premise that adverse outcomes are the result of a combination of factors of systemic issues such as resource availability, organizational policies and procedures, and human functional errors. Reason’s model is called the Swiss cheese model because every layer of defense against errors has it holes; the more layers, the smaller the risk of causing harm (ACSQC, 2004). There is less chance of the holes lining up to allow an error to occur.

  
 


Breakdown of a productive system
 

Reason’s Model Inputs

  Organizational factors
   
  Excessive cost cutting
   
  Inadequate promotion policies
   
  Unsafe supervision
   
  Deficient training
   
  Improper staffing mix
   
  Preconditions for unsafe acts
   
  Poor teamwork
   
  Poor resource management
   
  Loss of situational awareness
   
  Unsafe acts
   
  Incorrect calculation of dosage
   
  Workarounds
   
  Using equipment in a way that it was not designed to be used
   
  Did not communicate all the information
   
  Quality control checks not done
   

Reason (1990) said that "we cannot change the human condition, but we can change the conditions under which humans work." Using his model it is easier to understand that errors reflect problems at the practical level and the systemic level. A safe reporting system is used to ensure system integrity is monitored (ACSQC, 2004).

 

The Cognitive Process

The human cognitive process is how we remember, think, develop and use motor skills to perform activities individually, in teams and within organizational systems.

  Perception equals input - information perceived through the sensory system. With distracted or blurred perception (insufficient light, ambient noise, etc.) you are unable to take in sensory information, and more prone to misread a label or mishear spoken words.
   
  Long-term memory – information acquired through education and experience are stored in long-term memory. When long-term memory experiences interference (e.g. distraction, multi-tasking) there is difficulty retrieving and applying previously learned information.
   
  Working memory – information from the sensory fields (perception) and long-term memory combine to do the work we label "thinking." Thinking combines sensory input with stored knowledge to call up frequently used patterns and criteria that have been developed through common use to make decisions. When overloaded through physical or emotional demands, there is increased risk of making incorrect judgments based on confusion, or applying learned rules incorrectly.

 

Impact of Design

The impact of design on human factors has four different types of interactions and a wide variety of applications. The science applies an understanding of theories of physical, cultural, and psychological factors to the reduction in flawed behavior.

Interaction with machines and objects is the most studied area of human factors problems. Most human errors related to human/machine interactions are due to either the condition or training of the operator, bad design of the machine interface, or both. A bad design is one that does not conform to intuitive application. Design flaws can lead to incorrect use of equipment. Speed, stress, and fatigue increase the likelihood that bad design will lead to error.

Negative impacts of the work environment exist even with the best designed objects and machines. Human factors problems are encountered, stemming from the physical world around us. Physical space, layout, temperature, light, air quality, noise levels, and visual distractions can all interfere with or alter the ability to perform an activity. When these factors become obstacles they can manifest as inconveniencies or can be harmful. Fatigue from loss of sleep, circadian rhythm changes, and muscular effort expenditure has been identified as one of the major contributors to errors.

As creatures of habit, humans often seek to "workaround" a new system in order to maintain an old mind set. For example, to help technicians correctly assemble devices with multiple components, matching barcodes were encoded on adjoining components. By swiping each piece, correct assembly was assured. However, reviewers discovered that the procedure was frustrating for some users who, as a workaround, put matching copies of the bar coding on a paper and scanned the paper instead of the equipment pieces, enabling incorrect assembly. Nurses, too, have found that it is easier to scan the patient label from the medication administration sheet rather than taking the medication cart with scanner to the patient bedside to scan the patient identification band on the patient’s wrist.

When a system problem is solved in isolation and without consideration of how it might affect the rest of the system, unintended consequences can undo the benefit of the fix. An example of this is a computerized forcing function programmed into a hospital medication system to prevent the over-administration of potassium. This inadvertently prevented the administration of high doses when they were needed. A solution can exacerbate existing minor problems or actually create new opportunities for errors. This is the unintended consequence. Piloting and field testing solutions helps identify these "downstream consequences."

Human factors problems related to practice environment tend to be more transient than design problems. Lighting, noise, temperature, even physical space, can change from one patient encounter to the next. If the healthcare provider works in multiple practice settings, the opportunity for environmentally-related problems are equally multiplied. Other issues may include things like:

  Equipment models or brands vary
   
  Equipment storage is too high
   
  Equipment is not conveniently located
   
  Equipment is not located in a consistent place
   
  Environment is not set up to allow effective eye contact and discussion

 

Interactions with Others

In a variety of clinical services, care is provided through changing teams of providers over various timeframes and supported by many administrative personnel. Each person acts in his or her capacity to attend to the patient’s needs through his or her own professional and personal lens of mental model. Inadequate communication can lead to misalignment of mental models. Interactions among teams and entire systems of healthcare providers are an important area of human factors study. Inadequate communication was the second most frequent risk management issue identified in claims made from 1996 to 2000. Handoffs, passing on information or responsibility are a particular patient safety problem area.

Mental models are a deeply ingrained assumption, generalization, or even pictures/images that influence how we understand the world and how we take action. When two people have different mental models of the same situation or process, they are at risk of misinterpreting each other’s directions or intentions.

Teams of people working together need to share a common understanding of what needs to be done and how; for example, the same mental model. Teams need efficient communication that is remembered at least long enough for the recipient to take proper action as a result.

 

Applying Human Factors Science to Healthcare

Human factors apply wherever humans work. In healthcare, work environments are hazardous. Instruments are potential weapons; drugs are a potential poison; and every worker is a potential killer (ACSQC, 2004). The following are human factors problem areas in healthcare:

  Equipment changes and upgrades (training inadequate)
   
  Handoffs (poor communication)
   
  Infusion pumps (poor human interface)
   
  Fatigue
   
  Labeling (look alike, sound alike)
   
  Handling sharps
   
  Retained foreign bodies in surgery
   
  Patient bed alarms (false alarms and falls)
   
  Physician order entry (illegible, verbal orders, transcription errors)
   
  Wrong site surgery

Accept human factors problems as an inevitable, although manageable, part of everyday practice. Shift from a punitive to a creative frame of mind that seeks out and identifies the underlying system failures. Efficient, routine identification of human factors need to be part of every practice, as well as routine investigation of all human factors problems that cause injuries.

Not all design flaws in healthcare environments are obvious hazards. One of the most subtle mistakes is failure to realize that the best-motivated and most highly-trained professionals are potentially lethal agents (ACSQC, 2004). Fatigue management in healthcare is a big challenge. Fatigue resulting from an inadequate amount of sleep or insufficient quality of sleep over an extended period can lead to a number of problems, including (JCAHO, 2011, pg. 1):

  lapses in attention and inability to stay focused
   
  reduced motivation
   
  compromised problem solving
   
  confusion
   
  irritability
   
  memory lapses
   
  impaired communication
   
  slowed or faulty information processing and judgment
   
  diminished reaction time
   
  indifference and loss of empathy

Contributing factors to fatigue and risks to patients include (JCAHO, 2011, pg. 2):
Shift length and work schedules have a significant effect on health care providers’ quantity and quality of sleep and, consequently, on their job performance, as well as on the safety of their patients and their individual safety. This fact has been borne out in numerous studies. Findings from a groundbreaking 2004 study of 393 nurses over more than 5,300 shifts – the first in a series of studies of nurse fatigue and patient safety – showed that nurses who work shifts of 12.5 hours or longer are three times more likely to make an error in patient care.7 Additional studies show that longer shift length increased the risk of errors and close calls and were associated with decreased vigilance,7 and that nurses suffer higher rates of occupational injury when working shifts in excess of 12 hours.8 Still, while the dangers of extended work hours (more than 12 hours) are well known, the health care industry has been slow to adopt changes, particularly with regard to nursing.

Recommended actions (JCAHO, 2011, pg. 3):

1. Assess your organization for fatigue-related risks. This includes an assessment of off-shift hours and consecutive shift work, and a review of staffing and other relevant policies to ensure they address extended work shifts and hours.
   
2. Since patient hand-offs are a time of high-risk – especially for fatigued staff – assess your organization’s hand-off processes and procedures to ensure that they adequately protect patients.
   
3. Invite staff input into designing work schedules to minimize the potential for fatigue.
   
4. Create and implement a fatigue management plan that includes scientific strategies for fighting fatigue. These strategies can include: engaging in conversations with others (not just listening and nodding); doing something that involves physical action (even if it is just stretching); strategic caffeine consumption (don’t use caffeine when you’re already alert and avoid caffeine near bedtime); taking short naps (less than 45 minutes). These strategies are derived from studies conducted by the National Aeronautics and Space Administration (NASA), which state that people can maximize their success by trying different combinations of countermeasures to find what works for them. The NASA studies stress that the only way to counteract the severe consequences of sleepiness is to sleep.21 Strategies for determining shift durations and using caffeine to combat fatigue can be found in chapter 40 of "Patient Safety and Quality: An Evidence-Based Handbook for Nurses."
   
5. Educate staff about sleep hygiene and the effects of fatigue on patient safety. Sleep hygiene includes getting enough sleep and taking naps, practicing good sleep habits (for example, engaging in a relaxing pre-sleep routine, such as yoga or reading), and avoiding food, alcohol or stimulants (such as caffeine) that can impact sleep.

 

Medication Errors

Adverse drug events (ADEs) are a serious public health problem. It is estimated that (CDC, 2012 pg1):

  700,000 emergency department visits and 120,000 hospitalizations are due to ADEs annually;
   
  $3.5 billion is spent on extra medical costs of ADEs annually;
   
  At least 40% of costs of ambulatory (non-hospital settings) ADEs are estimated to be preventable.

The numbers of adverse drug events will likely grow due to (CDC, 2012, pg. 1):

  Development of new medications
   
  Discovery of new uses for older medications
   
  Aging American population
   
  Increase in the use of medications for disease prevention
   
  Increased coverage for prescription medications

Nurses are most likely to be blamed for medication errors because they are involved at the administration point. However, medication errors are complex and are rarely the result of one person’s actions. The medication system in hospitals is complicated. There are multiple steps and many individuals involved. Every time a document or medication changes hands, there is an increased potential for error.

Administering medication is a crucial nursing responsibility. To ensure safe and effective drug therapy, the nurse must to be familiar with indications, usual dosages, and intended effects of drugs. Remember the 5 rights: right patient, right drug, right dose, right route, and right time. Each patient must be assessed before administration and medication should be delayed or withheld if indicated.

One study found adherence by nurses to standard medication administration practice was very low. This adherence is reported below as ratios per item.

  Only 45•6% of nurses verified the amount of medication indicated on the vial at least once for at least one-second. In addition, only 6•5% read the name of the patient from the wristband. Administering the medication at the correct time guideline was observed 41•0% of the time. The guideline regarding hand washing before external and oral medications was followed only 4•5% of the time, although this figure was much higher for intravenous medications at 96•6%. Overall, among 31 categories regarding drug administration, 17•2 (± 3•6) items per person were followed, whereas 5•7 (± 1•2) items per person were violated… We found key instances in which nurses did not follow the guidelines, including many from the Five Rights. About one in four elements were violated overall. (Jeongeun, et.al. 2013).

Nurses’ medication error interception practices¬ are associated with lower rates of medication errors. One study defines these interceptive practices as (INQRI, 2012):

  independent comparisons between the medication administration record and patient record at the beginning of a nurse’s shift;
   
  determining the rationale for each ordered medication;
   
  requesting that physicians rewrite orders when improper abbreviations are used;
   
  and ensuring that patients and families are knowledgeable regarding the medication regimen so that they can question unexplained variances

The types of medication errors include: prescribing, omission, wrong time, unauthorized drug, improper dose, wrong drug preparation, wrong administration techniques, deteriorated drugs, improper monitoring and compliance, product errors, process errors and human errors. Areas that are particularly error prone are:

  Verbal orders
   
  Handwritten orders
   
  High-alert drugs
   
  Infusion pump errors
   
  Confusing drugs names

Handwritten and manually transcribed physician orders leave a lot of opportunity for errors. A computerized physician order entry, in which the physician must enter all orders by computer, eliminates handwriting and transcription errors. It also makes it possible to automatically check doses, drug-drug interactions, allergies and significant patient characteristics, like allergies and impaired renal function.

Meta-analysis of the research revealed that computerized physician order entry decreases the likelihood of error on that order by 48% (95% CI 41% to 55%). Given this effect size, and the degree of adoption of computerized order entry and use in hospitals in 2008, we estimate a 12.5% reduction in medication errors, or ~17.4 million medication errors averted in the USA in 1 year (Radley, et.al. 2013).

A computerized order entry system presents its own set of problems. There is a significant expense that smaller facilities may not be able to afford. Cost prohibitions or lack of space may limit the number of PCs to the point that practitioners have long wait times for computer access. It seems slow and inconvenient at times. In addition, physicians who are less computer savvy may be resistant to change.

A listing and resource for confusing drug names (look alike/sound alike) can be found at the following website
 

High-Alert Medications

Study has shown that the majority of medication errors resulting in death or serious injury were caused by a list of specific medications.

The Institute for Safe Medication Practices (ISMP) is a nonprofit organization devoted entirely to medication error prevention and safe medication use. ISMP represents over 35 years of experience in helping healthcare practitioners keep patients safe, and continues to lead efforts to improve the medication use process. The organization is known and respected worldwide as the premier resource for impartial, timely, and accurate medication safety information.

ISMP’s List of High Alert Medications (ISMP, 2013, pg1)

High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients. We hope you will use this list to determine which medications require special safeguards to reduce the risk of errors. This may include strategies like improving access to information about these drugs; limiting access to high-alert medications; using auxiliary labels and automated alerts; standardizing the ordering, storage, preparation, and administration of these products; and employing redundancies such as automated or independent double checks when necessary. (Note: manual independent double-checks are not always the optimal error-reduction strategy and may not be practical for all of the medications on the list).

 

Background

Based on error reports submitted to the ISMP National Medication Errors Reporting Program, reports of harmful errors in the literature, and input from practitioners and safety experts, ISMP created and periodically updates a list of potential high-alert medications. During October 2011-February 2012, 772 practitioners responded to an ISMP survey designed to identify which medications were most frequently considered high-alert drugs by individuals and organizations. Further, to assure relevance and completeness, the clinical staff at ISMP, members of our advisory board, and safety experts throughout the US were asked to review the potential list. This list of drugs and drug categories reflects the collective thinking of all who provided input.

 

Classes/Categories of Medications

adrenergic agonists, IV (e.g., EPINEPHrine, phenylephrine, norepinephrine)
adrenergic antagonists, IV (e.g., propranolol, metoprolol, labetalol)
anesthetic agents, general, inhaled and IV (e.g., propofol, ketamine)
antiarrhythmics, IV (e.g., lidocaine, amiodarone)
antithrombotic agents, including:
 
  anticoagulants (e.g., warfarin, low-molecular-weight heparin, IV unfractionated heparin)
   
  Factor Xa inhibitors (e.g., fondaparinux)
   
  direct thrombin inhibitors (e.g., argatroban, bivalirudin, dabigatran etexilate, lepirudin)
   
  thrombolytics (e.g., alteplase, reteplase, tenecteplase)
   
  glycoprotein IIb/IIIa inhibitors (e.g., eptifibatide)
cardioplegic solutions
chemotherapeutic agents, parenteral and oral
dextrose, hypertonic, 20% or greater<
dialysis solutions, peritoneal and hemodialysis
epidural or intrathecal medications
hypoglycemics, oral
inotropic medications, IV (e.g., digoxin, milrinone)
insulin, subcutaneous and IV
liposomal forms of drugs (e.g., liposomal amphotericin B) and conventional counterparts (e.g., amphotericin B desoxycholate)
moderate sedation agents, IV (e.g., dexmedetomidine, midazolam)
moderate sedation agents, oral, for children (e.g., chloral hydrate)
narcotics/opioids
 
  IV
   
  transdermal
   
  oral (including liquid concentrates, immediate and sustained-release formulations)
neuromuscular blocking agents (e.g., succinylcholine, rocuronium, vecuronium)
parenteral nutrition preparations
radiocontrast agents, IV
sterile water for injection, inhalation, and irrigation
(excluding pour bottles) in containers of 100 mL or more
sodium chloride for injection, hypertonic, greater than 0.9% concentration

Specific Medications

epoprostenol (Flolan), IV
magnesium sulfate injection
methotrexate, oral, non-oncologic use
opium tincture
oxytocin, IV
nitroprusside sodium for injection
potassium chloride for injection concentrate
potassium phosphates injection
promethazine, IV
vasopressin, IV or intraosseous

ISMP List of High-Alert Medications in
Community/Ambulatory Healthcare (ISMP, 2013, pg. 1)

High-alert medications are drugs that bear a heightened risk of causing significant patient harm when they are used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients. We hope you will use this list to determine which medications require special safeguards to reduce the risk of errors and minimize harm. This may include strategies like providing mandatory patient education; improving access to information about these drugs; using auxiliary labels and automated alerts; employing automated or independent double checks when necessary; and standardizing the prescribing, storage, dispensing, and administration of these products

Background

Based on error reports submitted to the ISMP Medication Errors Reporting Program (ISMP MERP), reports of harmful errors in the literature, and input from practitioners and safety experts, ISMP created a list of potential high alert medications. During June-August 2006, 463 practitioners responded to an ISMP survey designed to identify which medications were most frequently considered high alert drugs by individuals and organizations. In 2008, the preliminary list and survey data as well as data about preventable adverse drug events from the ISMP MERP, the Pennsylvania Patient Safety Reporting System, the FDA MedWatch database, databases from participating pharmacies, public litigation data, literature review, and a small focus group of ambulatory care pharmacists and medication safety experts were evaluated as part of a research study funded by an Agency for Healthcare Research and Quality (AHRQ) grant. This list of drugs and drug categories reflects the collective thinking of all who provided input. This list was created as part of the AHRQ funded project "Using risk models to identify and prioritize outpatient high alert medications" (Grant # 1P20HS01710701).

 

Classes/Categories of Medications

antiretroviral agents (e.g., efavirenz, lamiVUDine, raltegravir, ritonavir, combination antiretroviral products)
chemotherapeutic agents, oral (excluding hormonal agents) (e.g., cyclophosphamide, mercaptopurine, temozolomide)
hypoglycemic agents, oral
immunosuppressant agents (e.g., azaTHIOprine, cycloSPORINE, tacrolimus)
insulin, all formulations
opioids, all formulations
pediatric liquid medications that require measurement
pregnancy category X drugs (e.g., bosentan, ISOtretinoin)

Specific Medications

carBAMazepine
chloral hydrate liquid, for sedation of children
heparin, including unfractionated and low molecular weight heparin
metFORMIN
methotrexate, non-oncologic use
midazolam liquid, for sedation of children
propylthiouracil
warfarin

The following are drug specific strategies for prevention of medication errors (JCAHO, 2007).

Insulin:

  Establish a check system where one nurse prepares the dose and another nurse reviews it.
   
  Do not store insulin and heparin near each other.
   
  Spell out the word unit instead of using the abbreviation U.
   
  Build in an independent check system for infusion pump rates and concentration settings.

Opiates and Narcotics:

  Limit the opiates and narcotics available in floor stock.
   
  Educate staff about hydromorphone and morphine.
   
  Implement PCA protocols that include double checks of the drug, pump settings, and dosage.

Injectable Potassium Chloride (KCL) (or Phosphate):

  Remove concentrated KCL from floor stock.
   
  Move the drug preparation off the units and use commercially available premixed IV solutions.
   
  Standardize and limit drug concentrations.

Intravenous Anticoagulants:

  Standardize concentrations and use premixed solutions.
   
  Use only single-dose containers.
   
  Separate heparin and insulin.
   
  Remove heparin from the top of medication carts.

Sodium Chloride Solutions Concentration above 0.9%:

  Remove sodium Chloride concentration solutions above 0.9% from nursing units.
   
  Standardize and limit drug concentrations.
   
  Double check pump rate, drug concentration and line attachments.

 

Anticoagulants

The anticoagulants most commonly used and most frequently involved in medication error are unfractionated heparin, warfarin and enoxaparin (JCAHO, September 08). Contributing factors to medication error with the use of anticoagulants include (JCAHO, September 08, pg 1):

  Inadequate screening of patients for contraindications and drug interactions.
   
  Lack of standardized naming, labeling and packaging
   
  Keeping up the changes to the different dosing regimens, drug interactions and reversal agents is difficult, particularly for practitioner who not routinely prescribe anticoagulants
   
  Failure to document or communicate individualized instructions and current lab results during hand-offs
   
  Pediatric administration errors because anticoagulants are formulated and packaged for adults,

Risk reduction strategies (JCAHO, September 08, pg 1):

  Improve staff communication and information access
   
  Involve the patient in the management of anticoagulation therapy
   
  Implement a pharmacist managed anticoagulation service
   
  Use computerized provider order entry or barcoding technology

Other JCAHO recommendations (JCAHO, September, pg 1):

For all anticoagulants:

1. Perform an organizational-wide risk assessment for anticoagulant therapy.
   
2. Use best practices or evidence-based guidelines regarding the use of anticoagulants.
   
3. Establish organization-wide dose limits on anticoagulants and screen all orders for exceptions (i.e., require a confirmatory override by the physician).
   
4. Clearly label or otherwise differentiate syringes and other containers used for anticoagulant drugs.
   
5. Clarify all anticoagulant dosing for pediatric patients.
   
6. Promptly re-evaluate patients whose anticoagulant is being held for a procedure. The re-evaluation should include an assessment of the need to reorder anticoagulant therapy.
   
7.  Hospitals and ambulatory facilities should provide timely communication of all anticoagulant-associated lab values to the provider or the person managing the anticoagulation therapy.
   
8. Under the supervision of clinical staff, educate and assist inpatients who require anticoagulant drugs to practice administering their own medications. This will help reduce the risk of errors after discharge.

For heparin:

9. Consolidate and limit the number of institutional unfractionated heparin dosing nomograms. For all heparin medication orders (inpatient and outpatient), require prescribers to include the calculated dose and the dose per weight (e.g. milligrams per kilogram) or body surface area to facilitate an independent double-check of the calculation by a pharmacist, nurse or both. Note: For morbidly obese patients, the standard nomograms may not be accurate.
   
10. Before the start of a heparin infusion and with each change of the container or rate of infusion, require an independent double check of the drug, concentration, dose calculation, rate of infusion, pump settings, line attachment and patient identity.
   
11. Use heparin flush only for central lines and eliminate heparin flush of peripheral intravenous lines. Stock and use only pre-filled syringes commercially prepared at set unit doses for flush solutions.
   
12. Identify patients with heparin-induced antibodies and heparin-induced thrombocytopenia (HIT) to avoid life-threatening events from heparin exposure.
   
13. Dispense only preservative-free heparin to neonates and build an alert to pharmacists with this directive into order entry systems.

For warfarin:

14. Consider reports of INRs greater than three and episodes of vitamin K administration as possible indicators of warfarin-associated adverse drug events and take immediate steps to address these events.
   
15. Do not automatically discontinue warfarin according to automatic stop policies without verifying the drug’s indication and contacting the prescriber.

 

Pediatric Medication

Patient weight is the basis for calculating a lot of dosing of pediatric medications. Therefore an accurate weight should be done before administering any weight based medications, except in emergencies. The kilogram should be the standard for all pediatric weights. Pediatric patients are more prone to medication errors and more likely to be harmed from medication errors because (JCAHO, April 2008, pg 1):

  Most medications used in the care of children are formulated and packaged primarily for adults. Therefore, medications often must be prepared in different volumes or concentrations within the health care setting before being administered to children. The need to alter the original medication dosage requires a series of pediatric-specific calculations and tasks, each significantly increasing the possibility of error.
   
  Most health care settings are primarily built around the needs of adults. Many settings lack trained staff oriented to pediatric care, pediatric care protocols and safeguards, and/or up-to-date and easily accessible pediatric reference materials, especially with regard to medications. Emergency departments may be particularly risk-prone environments for children.
   
  Children—especially young, small and sick children—are usually less able to physiologically tolerate a medication error due to still developing renal, immune and hepatic functions.
   
  Many children, especially very young children, cannot communicate effectively to providers regarding any adverse effects that medications may be causing.
   
  JCAHO (April 2008, pg 1) recommends the following pediatric-specific strategies for reducing medication errors:
Standardize and identify medications effectively, as well as the processes for drug administration.
   
  Establish and maintain a functional pediatric formulary system with policies for drug evaluation, selection and therapeutic use.
   
  To prevent timing errors in medication administration, standardize how days are counted in all protocols by deciding upon a protocol start date (e.g., Day 0 or Day 1).
   
  Limit the number of concentrations and dose strengths of high alert medications to the minimum needed to provide safe care.
   
  For pediatric patients who are receiving compounded oral medications and total parenteral nutrition at home, ensure that the doses are equivalent to those prepared in the hospital (i.e., the volume of the home dose should be the same as the volume of the hospital prepared products).
   
  Use oral syringes to administer oral medications. The pharmacy should use oral syringes when preparing oral liquid medications. Make oral syringes available on patient care units when "as needed" medications are prepared. Educate staff about the benefits of oral syringes in preventing inadvertent intravenous administration of oral medications.

Ensure full pharmacy oversight—as well as the involvement of other appropriate staff—in the verifying, dispensing and administering of both neonatal and pediatric medications.

  Assign a practitioner trained in pediatrics to any committee that is responsible for the oversight of medication management.
   
  Provide ready access, including website access, to up-to-date pediatric-specific information for all hospital staff. This information should include pediatric research study data, pediatric growth charts, normal vital sign ranges for children, emergency dosage calculations, and drug reference materials with information about minimum effective doses and maximum dose limits.
   
  Orient all pharmacy staff to specialized neonatal/pediatric pharmacy services in your organization.
   
  Provide a dosage calculation sheet for each pediatric critical care patient, including both emergency and commonly used medications.
   
  Develop preprinted medication order forms and clinical pathways or protocols to reflect a standardized approach to care. Include reminders and information about monitoring parameters.
   
  Create pediatric satellite pharmacies or assign pharmacists and technicians with pediatric expertise to areas or services such as neonatal/pediatric critical care units and pediatric oncology units. At a minimum, pediatric medications should be stored and prepared in areas separate from those where adult medications are stored and prepared.

Use technology judiciously.

  Use methods to ensure the accuracy of technology that measures and delivers additives for intravenous solutions, such as for total parenteral nutrition.
   
  If dose and dose range checking software programs are available in hospital or pharmacy information systems, enable them to provide alerts for potentially incorrect doses.
   
  Medications in automated dispensing cabinets that do not undergo appropriate pharmacist review should be limited to those needed for emergency use and/or to those medications under the control of a licensed independent prescriber, as specified in Joint Commission standard MM 4.10.
   
  Recognize that the use of infusion pumps, or smart pumps, is not a guarantee against medication errors. Appropriate education for nurses, pharmacists and other caregivers regarding these technologies is important for all institutions caring for pediatric patients.
   
  To prevent adverse outcomes or oversedation, use consistent physiological monitoring – particularly pulse oximetry – while children are under sedation during office-based procedures. Use age- and size-appropriate monitoring equipment and follow uniform procedures under the guidance of staff appropriately trained in sedation, monitoring and resuscitation.
   
  Providers are encouraged to develop bar-coding technology with pediatric capability. Potential errors should be carefully considered while adapting this technology to pediatric processes and systems. For example, a pediatric bar-coding solution must be able to provide readable code for small-volume, patient-specific dose labels.

 

Infusion Pump Errors

The types of infusion pump errors seen are the use of pumps that do not protect from free–flow of fluids to the patient, the wrong drug concentration, or the wrong rate is set.

Free-flow of fluids occurs when the infusate flows freely, under the force of gravity, without being controlled by the infusion pump. Infusion pump tubing needs a built in, anti-free-flow mechanism. This prevents gravity free-flow by closing off the tubing to prohibit flow when the administration set is removed from the pump. If an infusion pump does not have free-flow protection, devices that attach to the administration set are available. However, they are not recommended, because the mechanisms are packaged separately and must be manually attached to a set. Clinicians may forget to use the mechanism or may accidentally remove them.

Training and education are important in the prevention of infusion pump administration errors. Be sure to in-service staff who may not be administering medication, but may be handling the infusion pumps, such as aides, radiology technicians and transporters. Another concern is that patients, family members or visitors may mishandle pumps.

Key bump errors can cause errors in the volume or infusion rate. These should be double checked after entry and before starting the pump. Having a second nurse check calculations and settings for infusion pumps when high-alert drugs are used is recommended.

 

Medication Reconciliation

Medication reconciliation is done to avoid medication errors. Hand-off situations are prone to errors. Errors can be omission, duplication, contraindications, prescription errors and administration errors. Therefore, the process should be done every time a patient has a hand off (transition in care). A hand-off includes change in setting, service, practitioner, or level of care (JCAHO, January 2006). Medication reconciliation has five steps (JCAHO, January, 2006, pg 1):

  develop a list of current medications
   
  develop a list of medications to be prescribed
   
  compare the medications on the two lists
   
  make clinical decisions based on the comparison
   
  Communicate the new list to appropriate caregivers and to the patient.

When the patient has difficulty with the instructions, someone must be designated and taught about the patient’s medications.

Risk reduction strategies include (JCAHO, January, 2006, pg 1):

  Collect a complete list of current medications (including dose and frequency along with other key information) for each patient on admission.
   
  Validate the home medication list with the patient (whenever possible).
   
  Assign primary responsibility for collecting the home list to someone with sufficient expertise, within a context of shared accountability.
   
  Use the home medication list when writing orders.

Place the reconciling form in a consistent, highly visible location within the patient chart (easily accessible by clinicians writing orders).

  Assign responsibility for comparing admission orders to the home medication list, identifying discrepancies, and reconciling variances to someone with sufficient expertise.
   
  Reconcile medications within specified time frames (within 24 hours of admission; shorter time frames for high-risk drugs, potentially serious dosage variances, and/or upcoming administration times).
   
  Adopt a standardized form to use for collecting the home medication list and for reconciling the variances (includes both electronic and paper-based forms).
   
   Develop clear policies and procedures for each step in the reconciliation process.
   
  Provide access to drug information and pharmacist advice at each step in the reconciliation process.
   
  Improve access to complete medication lists at admission.
   
  Provide orientation and ongoing education on procedures for reconciling medications to all health care providers.
   
  Provide feedback, on-going monitoring.

JCAHO recommendations include (JCAHO, January, 2006, pg 1):

1. Placing the medication list in a highly visible location in the patient's chart and including dosage, drug schedules, immunizations, and allergies or drug intolerances on the list.
   
2. Creating a process for reconciling medications at all interfaces of care (admission, transfer, discharge) and determining reasonable time frames for reconciling medications. Patients, and responsible physicians, nurses and pharmacists should be involved in the medication reconciliation process.
   
3. On discharge from the facility, in addition to communicating an updated list to the next provider of care, provide the patient with the complete list of medications* that he or she will be taking after discharge from the facility, as well as instructions on how and how long to continue taking any newly prescribed medications. Encourage the patient to carry the list with him or her and to share the list with any providers of care, including primary care and specialist physicians, nurses, pharmacists and other caregivers.
   

 

Disruptive Behavior

Medical errors are fostered by intimidating and disruptive behaviors. Left unchecked, these behaviors lead to increased turnover, interfere with communication, and interfere with teamwork. "It is important that organizations recognize that it is the behaviors that threaten patient safety, irrespective of who engages in them" (JCAHO, July 08, pg 1).

Most healthcare providers have experienced or witnessed intimidating or disruptive behaviors. One survey reported that "40 percent of clinicians have kept quiet or remained passive during patient care events rather than question a known intimidator" (JCAHO, July 08, pg 1). Intimidating and disruptive behaviors include active and passive behavior such as (JCAHO, July 08, pg 1):

  Verbal outbursts
   
  Physical threats
   
  Refusing to perform assigned tasks
   
  Quietly exhibiting uncooperative attitudes during routine activities

When manifested by health care professionals in positions of power, these behaviors include (JCAHO, July 08, pg 1):

  Reluctance or refusal to communicate (i.e. answer questions, return phone calls or pages)
   
  Condescending language or voice intonation
   
  Impatience with questions

Disruptive behaviors are often not address because the behavior is not reported. There is fear of retaliation, the stigma of whistle blowing, and reluctance to confront an intimidator. In one survey, almost 39 % of physician acknowledged that physicians who generate high revenue are treated more leniently concerning behavior problems (JCAHO, July 08).

January 1, 2009, JCAHO implemented a new Leadership standard (LD.03.01.01) that addresses disruptive and inappropriate behaviors in two elements of performance (JCAHO, July 08, pg 1):

  The hospital/organization has a code of conduct that defines acceptable and disruptive and inappropriate behaviors.
   
  Leaders create and implement a process for managing disruptive and inappropriate behaviors.
   

 

Tubing Misconnection

Misconnection of tubing can lead to patient deaths. Causative factors include (JCAHO, April, 06, pg 1):

  Luer connectors enable functionally dissimilar tubes or catheters to be connected
   
  the routine use of tubes or catheters for unintended purposes
   
  the positioning of functionally dissimilar tubes used in patient care in close proximity to one another
   
  movement of the patient from one setting or service to another
   
  staff fatigue associated with working consecutive shifts

Error reduction recommendations include (JCAHO, April, 06, pg 1):

1. Do not purchase non-intravenous equipment that is equipped with connectors that can physically mate with a female luer IV line connector.
   
2. Conduct acceptance testing (for performance, safety and usability) and, as appropriate, risk assessment (e.g., failure mode and effect analysis) on new tubing and catheter purchases to identify the potential for misconnections and take appropriate preventive measures.
   
3. Always trace a tube or catheter from the patient to the point of origin before connecting any new device or infusion.
   
4. Recheck connections and trace all patient tubes and catheters to their sources upon the patient’s arrival to a new setting or service as part of the hand-off process. Standardize this "line reconciliation" process.
   
5. Route tubes and catheters having different purposes in different, standardized directions (e.g., IV lines routed toward the head; enteric lines toward the feet). This is especially important in the care of neonates.
   
6. Inform non-clinical staff, patients and their families that they must get help from clinical staff whenever there is a real or perceived need to connect or disconnect devices or infusions.
   
7. For certain high-risk catheters (e.g., epidural, intrathecal, arterial), label the catheter and do not use catheters that have injection ports.
   
8. Never use a standard luer syringe for oral medications or enteric feedings.
   
9. Emphasize the risk of tubing misconnections in orientation and training curricula.
   
10. Identify and manage conditions and practices that may contribute to health care worker fatigue, and take appropriate action.

 

Technology

Health information technology and converging technologies have been found to contribute to medical errors. Care must be taken when implementing new technology. Contributing factors include (JCAHO, December 08, pg 1):

  Inadequate technology planning can result in poor product selection, a solution that does not adapt well to the local clinical environment, or insufficient testing or training
   
  Failing to include front-line clinicians in the planning process,
   
  Failing to consider the costs and resources needed for ongoing maintenance
   
  Failure to consult product safety reviews or alerts or the previous experience of others
   
  Implementing new clinical information systems can expose latent problems or flawed processes with existing manual systems
   
  An over-reliance on vendor advice can lead to problems
   
  Learning to use new technologies takes time and attention, sometimes placing strain on demanding schedules
   
  Failure to quickly fix technology when it becomes counterproductive can lead to dangerous workarounds
   
  Excessive alerts leads to alert fatigue, where staff overlook important alerts

Recommended actions include (JCAHO, 12/08, pg. 1):

1. Examine workflow processes and procedures for risks and inefficiencies and resolve these issues prior to any technology implementation. Involving representatives of all disciplines—whether they are clinical, clerical or technical—will help in the examination and resolution of these issues.
   
2. Actively involve clinicians and staff who will ultimately use or be affected by the technology, along with IT staff with strong clinical experience, in the planning, selection, design, reassessment and ongoing quality improvement of technology solutions, including the system selection process. Involve a pharmacist in the planning and implementation of any technology that involves medication.
   
3. Assess your organization’s technology needs beforehand (e.g., supporting infrastructure; communication of admissions, discharges, transfers, etc.). Investigate how best to meet those needs by requiring IT staff to interact with users outside their own facility to learn about real world capabilities of potential systems, including those of various vendors; conduct field trips; and look at integrated systems (to minimize reliance on interfaces between various vendor systems).
   
4. During the introduction of new technology, continuously monitor for problems and address any issues as quickly as possible, particularly problems obscured by workarounds or incomplete error reporting. During the early post-live phase, consider implementing an emergent issues desk staffed with project experts and champions to help rapidly resolve critical problems. Use interdisciplinary brainstorming methods for improving system quality and giving feedback to vendors.
   
5. Establish a training program for all types of clinicians and operations staff who will be using the technology and provide frequent refresher courses.
Training should be appropriately designed for the local staff. Focus training on how the technology will benefit patients and staff, i.e. less inefficiency, fewer delays and less repeated work. Do not allow long delays between orientation and system implementation.
   
6. Develop and communicate policies delineating staff authorized and responsible for technology implementation, use, oversight, and safety review.
   
7. Prior to taking a technology live, ensure that all standardized order sets and guidelines are developed, tested on paper, and approved by the Pharmacy and Therapeutics Committee (or institutional equivalent).
   
8. Develop a graduated system of safety alerts in the new technology that helps clinicians determine urgency and relevancy. Carefully review skipped or rejected alerts as important insight into clinical practice. Decide which alerts need to be hard stops when using the technology and provide appropriate supporting documentation.
   
9. Develop a system that mitigates potential harmful CPOE drug orders by requiring departmental or pharmacy review and sign off on orders that are created outside the usual parameters. Use the Pharmacy and Therapeutics Committee (or institutional equivalent) for oversight and approval of all electronic order sets and clinical decision support alerts. Assure proper nomenclature and printed label design, eliminate dangerous abbreviations and dose designations, and ensure MAR acceptance by nurses.
   
10. To improve safety, provide an environment that protects staff involved in data entry from undue distractions when using the technology.
   
11. After implementation, continually reassess and enhance safety effectiveness and error-detection capability, including the use of error tracking tools and the evaluation of near-miss events. Maximize the potential of the technology in order to maximize the safety benefits.
   
12. After implementation, continually monitor and report errors and near misses or close calls caused by technology through manual or automated surveillance techniques. Pursue system errors and multiple causations through the root cause analysis process11 or other forms of failure-mode analysis. Consider reporting significant issues to well recognized external reporting systems.
   
13. Re-evaluate the applicability of security and confidentiality protocols as more medical devices interface with the IT network. Reassess HIPAA compliance on a periodic basis to ensure that the addition of medical devices to your IT network and the growing responsibilities of the IT department haven’t introduced new security and compliance risks.2

 

Medical Device Alarm Safety

Alarm-equipped devices are essential to providing safe care to patients in many health care settings. The number of alarm signals per day can reach several hundred, depending on the unit. "It is estimated that between 85 and 99 percent of alarm signals do not require clinical intervention, such as when alarm conditions are set too tight; default settings are not adjusted for the individual patient or for the patient population; ECG electrodes have dried out; or sensors are mispositioned (JCAHO, 201, pg. 1)." Therefore, staff become desensitized or immune to the sounds, and are overwhelmed by information. This is called alarm fatigue.

Major contributing factors to sentinel events involving medical device alarms were (JCAHO, 2013, pg. 2):

  Absent or inadequate alarm system
   
  Improper alarm settings
   
  Alarm signals not audible in all areas
   
  Alarm signals inappropriately turned off

Factors that contribute to alarm-related sentinel events include (JCAHO, 2013, pg. 2):

  Alarm fatigue – the most common contributing factor
   
  Alarm settings that are not customized to the individual patient or patient population
   
  Inadequate staff training on the proper use and functioning of the equipment (e.g., inconsistent team training, response, and interpretation of alarm signals)
   
  Inadequate staffing to support or respond to alarm signals
   
  Alarm conditions and settings that are not integrated with other medical devices
   
  Equipment malfunctions and failures

Recommended actions include: (JCAHO, 2013, pg.3)

1. Leadership ensures that there is a process for safe alarm management and response in high-risk areas (as identified by the organization).
   
2. Prepare an inventory of alarm-equipped medical devices used in high-risk areas and for high-risk clinical conditions, and identify the default alarm settings and the limits appropriate for each care area.
   
3. Establish guidelines for alarm settings on alarm-equipped medical devices used in high-risk areas and for high-risk clinical conditions; include identification of situations when alarm signals are not clinically necessary.
   
4. Establish guidelines for tailoring alarm settings and limits for individual patients. The guidelines should address situations when limits can be modified to minimize alarm signals and the extent to which alarms can be modified to minimize alarm signals.
   
5. Inspect, check, and maintain alarm-equipped devices to provide for accurate and appropriate alarm settings, proper operation, and detectability. Base the frequency of these activities on criteria such as manufacturers’ recommendations, risk levels, and current experience.

 

National Patient Safety Goals

JCAHO has made patient safety a priority and is seeking to promote specific improvements in patient safety. The mechanism for doing this is the use of National Patient Safety Goals (NPSGs) as a major focus for accreditation visits. The NPSGs highlight problematic areas and seek system wide solutions and are being updated annually. The following is the link to NPSGs.

Hold the ctrl button and right click on the name of the list to be taken to the website.

NPSG Program Links

  Ambulatory Health Care
   
  Behavioral Health Care
   
  Critical Access Hospital
   
  Home Care
   
  Hospitals
   
  Laboratory Services
   
  Long Term Care
   
  Long Term Care (Medicare/Medicaid)
   
  Office-Based Surgery

The following are the 2013 Hospital National Patient Safety Goals (JCAHO, 2013).

Identify patients correctly

  Use at least two ways to identify patients. For example, use the patient’s name and date of birth.
   
  This is done to make sure that each patient gets the correct medicine and treatment.
   
  Make sure that the correct patient gets the correct blood when they get a blood transfusion.

Improve staff communication

  Get important test results to the right staff person on time.
   

Use medicines safely

  Before a procedure, label medicines that are not labeled. For example, medicines in syringes, cups and basins. Do this in the area where medicines and supplies are set up.
   
  Take extra care with patients who take medicines to thin their blood.
   
  Record and pass along correct information about a patient’s medicines.
   
  Find out what medicines the patient is taking. Compare those medicines to new medicines given to the patient. Make sure the patient knows which medicines to take when they are at home. Tell the patient it is important to bring their up-to-date list of medicines every time they visit a doctor.

Prevent infection

  Before a procedure, label medicines that are not labeled. For example, medicines in syringes, cups and basins. Do this in the area where medicines and supplies are set up.
   
  Use the hand cleaning guidelines from the Centers for Disease Control and Prevention or the World Health Organization. Set goals for improving hand cleaning. Use the goals to improve hand cleaning.
   
  Use proven guidelines to prevent infections that are difficult to treat.
   
  Use proven guidelines to prevent infection of the blood from central lines.
   
  Use proven guidelines to prevent infection after surgery.
   
  Use proven guidelines to prevent infections of the urinary tract that are caused by catheters

Identify patient safety risks

  Find out which patients are most likely to try to commit suicide.

Prevent mistakes in surgery

  Make sure that the correct surgery is done on the correct patient and at the correct place on the patient’s body.
   
  Mark the correct place on the patient’s body where the surgery is to be done.
   
  Pause before the surgery to make sure that a mistake is not being made.

Do Not Use Abbreviations are also a focus of JCAHO accreditation visits. The following is a link to the JCAHO Facts about Do Not Use Abbreviations.

 

Conclusion

Healthcare professionals have a responsibility to be knowledgeable about the PI process and to participate as opportunity presents. Healthcare professionals also have a responsibility to be aware of clinical situation that are prone to error, and to participate in procedures to prevent those errors.

Systems redesign to prevent all such errors should be based on a balanced utilization of evidenced-based technology, training, on-going education, standards of practice and best practices, keeping in mind each human’s inherent cognitive and physical limitations.

Human factors lead to medical errors. Human factors errors can be reduced through the application of scientific method. Human errors are inevitable within healthcare settings. Human factors analysis needs to be part of every medical error investigation.

 

References

Australian Council for Safety and Quality in Healthcare Council (2004) Setting the Human Factor Standards for Healthcare: Do Lessons from Aviation Apply?

Balik B, Conway J, Zipperer L, Watson J. (2011) Achieving an Exceptional Patient and Family Experience of Inpatient Hospital Care. IHI Innovation Series white paper. Cambridge, Massachusetts: Institute for Healthcare Improvement. Retrieved 10/18/13

CDC. (2012) Medication Safety Basics Overview. 8/14/12. Retrieved 10/21/13

Chassin, M. & Loeb, J. (2011). The Ongoing Quality Improvement Journey: Next Stop, High Reliability. Health Affairs. Retrieved 10/18/13

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