ATrain Education


Continuing Education for Health Professionals

Course Modules

  • Course Introduction
  1. Medical Errors: An Overview
  2. Florida Reporting Requirements
  3. Types of Medical Errors
  4. Factors Increasing the Risk of Medical Errors
  5. Vulnerable Populations
  6. Reducing Errors and Increasing Patient Safety
  7. Public Awareness and Education
  8. Systems Approaches to Reducing Medical Errors
  9. Conclusion
  10. Resources and References
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FL: Preventing Medical Errors

For most healthcare professionals in Florida, this course meets the two-unit requirement on prevention and reporting of medical errors for initial licensure or biennial renewal.

We recommend you check with your board before you take this course.

Florida PTs/PTAs please click here for your Florida Physical Therapy Association approved course.

  • Author:
    • Cindy Kibbe, BS (CLS)

      Cindy Kibbe is an Arizona-based editor, writer, and business consultant with more than a decade of award-winning journalism experience. Her articles have appeared in Business Arizona, Business NH Magazine, New Hampshire Magazine, New Hampshire Business Review, New Hampshire Magazine BRIDE, and the Nashua Telegraph. Kibbe also wrote and contributed to New Hampshire Public Radio and has made a guest appearance on New Hampshire Public Television. She served as assistant editor for New Hampshire Business Review for nearly ten years.

      Prior to becoming a journalist, Kibbe had a long career in healthcare, including clinical practice as a registered medical technologist. She held positions in quality management and IT project management within the healthcare industry, where she wrote policies and procedures for national vendors that were used by clients across the country. She has a Bachelor of Science degree in Clinical Laboratory Sciences from Arizona State University.

      In her free time, Cindy volunteers at her church and at several local chambers of commerce.

    • JoAnn O'Toole, RN, BSN

      JoAnn O’Toole, RN, BSN,is a registered nurse, writer, and researcher. While in college at San Jose State University and later at the University of Mexico in Mexico City, she carried a double major in Spanish and journalism and a minor in Latin.

      She currently works in the Emergency Department at Kaiser Hospital in Redwood City, California, a certified stroke center and a sepsis center.

    • Susan Walters Schmid, PhD

      Susan Schmid earned BA degrees in History and European Studies from George Mason University, a Master's degree in Public History from Appalachian State University, and a PhD in History from Arizona State University.

      In addition to her PhD she earned a Certificate in Scholarly Publishing from ASU. Susan has served as an editor for several scholarly presses. She worked as a desktop publishing specialist for Arizona State University and taught several courses for the History Department as well as "Introduction to Scholarly Publishing" and "Scholarly Editing" for the Scholarly Publishing Program.


  • Contact hours: 2
  • Pharmacotherapy hours: 1
  • Expiration date: December 31, 2019
  • Course price: $19

Course Summary

Outlines seven types of medical errors and the Florida laws related to them. Describes factors that increase the risk of committing a medical error and populations that are especially vulnerable to such errors. Presents five commonly used approaches that have been effective in reducing medical errors.

The following information applies to occupational therapy professionals:

  • Target Audience: Occupational Therapists, OTAs
  • Instructional Level: Introductory
  • Content Focus: Target Audience: Occupational Therapists, OTAs Instructional Level: Introductory Content Focus: Category 1—Domain of OT, Client factors Category 3—Professional Issues

Criteria for Successful Completion

80% or higher on the post test, a completed evaluation form, and payment where required. No partial credit will be awarded.

Conflict of Interest/Commercial Support

Conflict of Interest/Commercial Support

Accredited status does not imply endorsement by ATrain Education Inc. or by the American Nurses Credentialing Center or any other accrediting agency of any products discussed or displayed in this course. The planners and authors of this course have declared no conflict of interest and all information is provided fairly and without bias. No commercial support was received for this activity.

Accreditation Information

Objectives: When you finish this course you will be able to:

  • Name several landmark pieces of legislation that have attempted to reduce medical errors.
  • Summarize Florida laws and requirements related to medical errors and describe the impact of the Patient Safety Quality and Improvement Act on healthcare practices in the United States.
  • Outline the seven main classifications of medical errors.
  • Identify factors and practices that increase the risk of committing a medical error.
  • Discuss populations that are particularly vulnerable to the effects of medical errors.
  • State several healthcare practices that will reduce medical errors and create a culture of patient safety.
  • State several measures the public can do to help reduce medical errors.
  • Explain the systems approach to medical errors and assess commonly used systems approaches shown to be effective.

Medical Errors: An Overview


Human beings, in all lines of work, make errors. Errors can be prevented by designing systems that make it hard for people to do the wrong thing and easy for people to do the right thing.

Institute of Medicine, 1999
To Err Is Human: Building a Safer Health System


More than 15 years ago, the Institute of Medicine (IOM) released its landmark report “To Err is Human: Building a Safer Health System,” and with it, raised the consciousness of medical errors within the nation’s healthcare system (IOM, 1999). Since that report was published, everyone from practitioners in rural clinics to legislators crafting national quality standards is intensely scrutinizing medical errors and their prevention.

Scope of the Problem

Medical errors are a common occurrence in the healthcare industry. The IOM report estimated 44,000 to 98,000 deaths each year in the United States, or at least 120 deaths per day, because of human error related to the delivery of healthcare (IOM, 1999).

Recent research puts that figure at fourfold—a staggering 400,000 people die each year from preventable adverse events. Put another way, as many people die from medical errors alone than chronic lower respiratory diseases, accidents and stroke combined, making it the third leading cause of death in the United States (James, 2013; CDC, 2015). In fact, a 2007 study by the Centers for Medicare and Medicaid Services and the IOM pegged as many as 1.5 million people experienced some kind of adverse drug event—just one of several types of medical errors—each year (IOM, 2007).

It is clear medical errors continue to occur in epidemic proportions, making continued vigilance an imperative for both healthcare workers and the public.

What can be done to reduce and ultimately rid the American healthcare system of these errors? Wachter and Shojania (2004), in their book, Internal Bleeding, say “the problem is relatively straightforward and could be solved if all errors were reported to newspapers and to regulators, bad-apple physicians and nurses were purged, and sleep-deprived residents and interns were allowed to get a little shut-eye.” They contend that most errors are made by “good but fallible people” who are working within flawed systems, and that the systems need to be fixed. “It’s as if we spent the last thirty years building a really souped-up sports car, but barely a dime or a moment in making sure it has bumpers, seat belts, and airbags.”

PSOs and The Patient Safety Act of 2005

In 2005 the U.S. Congress enacted the Patient Safety and Quality Improvement Act (Public Law 109-41) to improve patient safety by encouraging voluntary and confidential reporting of adverse events affecting patients. It also called for a culture of safety by establishing strong federal confidentiality and privilege protections for information assembled and developed by providers for analysis and discussion regarding quality and safety (PSOP, n.d.; Howie, 2009).

By creating a network of Patient Safety Organizations (PSOs), as encouraged by the Patient Safety Act, to collect and analyze confidential information reported by healthcare providers, organizations have a process to identify patterns of failure and propose measures to eliminate patient safety risks. There are 81 total PSOs in 29 states and the District of Columbia currently listed by AHRQ. Currently, 46 PSOs serve Florida, with seven domiciled in the Sunshine State (all PSOs can operate nationally regardless of their home state) (PSOP, n.d.-a).

Additional federal PSO regulations issued by the U.S. Department of Health and Human Services (HHS) in 2008 went into effect on January 19, 2009 (the Patient Safety and Quality Improvement Final Rule [Patient Safety Rule]). “The Patient Safety Rule establishes a framework by which hospitals, doctors, and healthcare providers may voluntarily report information to PSOs on a privileged and confidential basis, for the aggregation and analysis of patient safety events.” It also delineates the requirements to be met to become a PSO and how applicants will be reviewed and certified (PSOP, n.d.; PSOP, n.d.-b).

The CMS Prospective Payment Rule

In as effort to improve patient safety and curb costs, the Centers for Medicare and Medicaid (CMS) since 2008 no longer reimburses hospitals for care nor allows the hospital to charge the patient due to certain medical errors. The initial list had 10 “hospital-acquired conditions,” but as of 2015, the CMS has expanded the list to 14:

  1. Foreign object retained after surgery
  2. Air embolism
  3. Blood incompatibility
  4. Stages III and IV pressure ulcers
  5. Falls and trauma
  6. Manifestations of poor glycemic control
  7. Catheter-associated urinary tract infection (UTI)
  8. Vascular catheter-associated infection
  9. Surgical site infection, mediastinitis, following coronary artery bypass graft (CABG)
  10. Surgical site infection following bariatric surgery for obesity
  11. Surgical site infection following certain orthopedic procedures
  12. Surgical site infection following cardiac implantable electronic device (CIED)
  13. Deep vein thrombosis (DVT)/pulmonary embolism (PE) following certain orthopedic procedures
  14. Iatrogenic pneumothorax with venous catheterization (CMS, 2014)

Provisions like the CMS non-payment for preventable errors appear to be having a positive effect, at least in Florida. A 2013 study using the discharge data from the Florida Agency for Healthcare Administration from 2007 to 2011 suggested “Medicare nonpayment policy is associated with both a decline in the rate of hospital-acquired [vascular catheter-associated infections] (HA-VCAI) per quarter, and the probability of acquiring HA-VCAI post-policy.” Concurrent infection control practices, however, could have also affected the results (Peasah et al., 2013).

The fact that CMS continues to put medical errors under scrutiny—along with their financial ramifications—is another indication of the serious and pervasive nature of these preventable events.

The Affordable Care Act of 2010 (ACA)

Reducing medical errors and adverse events in healthcare continues to be an important topic in today’s legal landscape. A major theme of the landmark legislation Patient Protection and Affordable Care Act of 2010 (ACA, or “ObamaCare”) is improving the quality of the nation’s healthcare. The act has many provisions supporting programs that reduce medical errors and governance on their reporting. For example, ACA “in awarding [demonstration grants for alternatives to medical tort litigation], the Secretary shall give preference to States. . . that make proposals that are likely to enhance patient safety by detecting, analyzing, and helping to reduce medical errors and adverse events” (U.S. House, 2010; KFF, 2013).

In 2012 provisions in ACA required providers to begin moving towards electronic health records in an effort to reduce medical errors. Another ACA program also began in 2012 that offered financial incentives to hospitals that meet certain quality criteria (HHS, 2015).

Error Reporting: Fear and Finger Pointing

Traditionally, patient safety improvement efforts have been hampered by fear of discovery, resulting in under-reporting of medical errors and an inability to collect sufficient data for analysis of adverse events.

Although prior to publication of the IOM report virtually all healthcare organizations engaged in investigations of events that caused harm to patients, few took a systems-based approach to solving problems. The focus was on individuals and mistakes, rather than on the events that combined to cause an incident to occur. “Based on a ‘name and blame’ culture, the emphasis of such investigations was not on prevention, but on punishment” (USDVA, 2015).

The trend in developing programs has moved away from a solely regulatory function toward both regulatory and patient safety improvement goals. Many states have developed electronic methods for data collection and reporting, and there is a push toward standardization to make data comparisons more meaningful.

In an effort to provide a framework as well as a level playing field, the National Quality Forum, a nonprofit organization focused on systemic healthcare quality improvement, in 2002 developed a list of reportable events. The most recent review in 2011 resulted in 29 reportable events (NQF, 2011).

When To Err is Human was released in 1999, 13 states were collecting information on medical errors. As of July 2015, 27 states—including Florida—as well as the District of Columbia have a state adverse-event reporting system (Hanlon et al., 2015).

While this is an improvement since the IOM study’s release, we still have a long way to go. A persistent problem remains with the under-reporting of events despite statutory measures intended to address the problem (Hanlon et al., 2015; Yale, 2008).

Florida Reporting Requirements


More people die in a given year as a result of medical errors than from motor vehicle accidents, breast cancer, or AIDS.

Institute of Medicine, 1999
To Err is Human: Building a Safer Health System


Historical Error Reporting

In 2004, largely in response to the 1999 IOM report, the Florida legislature established the Florida Patient Safety Corporation (FPSC), whose purpose was to monitor patient safety throughout the state. An important goal of the FPSC was to establish a voluntary Near Miss Reporting System, based on a successful system used in the commercial aviation industry. The system was intended to provide immunity from legal penalties and sanctions (Florida Statutes, 2004; FL OPPAGA, 2006).

In 2004 two amendments to the state constitution were passed by Florida voters: the Patients’ Right-to-Know About Adverse Medical Incidents Act (known at the time as Amendment 7, but now Article 10, Section 25 of the Florida Constitution); and the Three Strikes and You Are Out Act (Amendment 8) (Florida Senate, 2007).

Writing the following year for “AHRQ: Morbidity and Mortality Rounds on the Web,” Paul Barach noted that Amendment 7 had eliminated the confidentiality provisions, allowing full access to all patient records, meetings, morbidity and mortality conferences, root cause analyses, and any other professional exchanges of information related to a patient’s injury or death. Brach noted that risk management professionals said that Amendment 7 had done immense harm to quality assurance and peer-review protections developed over the previous twenty years and caused an immediate decline in the reporting of adverse events throughout the state. Amendment 8 also had an unintended chilling effect on the reporting of near misses and adverse events (Barach, 2005).

The two amendments to the state constitution did indeed introduce a great deal of confusion and uncertainty into the Florida medical errors situation and they exacerbated an already recognized issue with under-reporting of adverse events. Approximately three dozen court cases were filed in the four years following the passage of Amendment 7, with lower-court decisions ruling both for and against the release of information. In 2008 two cases eventually found their way to the Florida Supreme Court, which rendered its decision in favor of Amendment 7 in both cases (Florida Senate, 2008; Rosenfeld, 2008).

Since 2004 the FPSC had followed its legislative mandate to establish itself as a working entity until it was repealed in 2009. It acquired preliminary certification as a Patient Safety Organization (PSO) from the Agency for Healthcare Research and Quality (AHRQ) and created the Near Miss Reporting System.

In 2008 the FPSC officially endorsed a private program called SorryWorks!, an independent disclosure consultancy firm, as an effective method for addressing medical errors. The goal of SorryWorks!, which is still in operation, is to establish a process that involves an initial disclosure, close contact with the patient and family, and a resolution that includes open communication. The main points are to disclose and compensate quickly when an error has occurred, vigorously defend medically appropriate care, and learn from mistakes (PSQH, 2008). According to the Sorry Works! website, Florida is one of thirty-six states with an “apology law” on the books, but these vary widely from state to state (SorryWorks!, n.d.).

State funding for the FPSC ended after the 2007–2008 fiscal year, and the first casualty was the Near Miss Reporting System. Part of its establishing legislation required it to obtain grants and other private funding to fully support itself. It was never able to do so; and, in fact, the FPSC believed that some funding should always come from the state as a show of support for its mission (Florida Senate, 2007).

Although the state Office of Program Policy Analysis and Government Accountability (OPPAGA) recommended the corporation continue and extend the exceptions allowing confidentiality of reports, it was unclear how the latter would fit with the Florida Supreme Court decisions regarding Amendment 7. On January 29, 2009, the FPSC Board of Directors voted to seek repeal of the statutes establishing the corporation and this was accomplished in May 2009 (Florida Senate, 2009; FL OPPAGA, 2006; Florida House, 2009; Florida Senate, 2009a; Laws of Florida, 2009.

Reports in the Florida media in 2011 suggested the system remained in a state of paralysis, in part due to conflicts (or perceived conflicts) between state and federal laws and in part because the apparent refusal of some hospitals to make available reports of adverse events. The situation, however, was and still is extremely complex, and the issues and laws vary depending on who is requesting what information and for what reasons.

The Florida General Counsel’s Office, on July 1, 2008, notified risk managers that information reported to the Florida Agency for Health Care Administration under state law was exempt from Amendment 7 mandates. For PSOs, such as the Patient Safety Organization of Florida Inc., formed in 2009, federal law supersedes state law in providing confidentiality for records (CBS Local Media, 2011; Florida General Counsel, 2008; PSOFlorida, 2009).

It appears that the Patients’ Right-to-Know About Adverse Medical Incidents Act in the 2015 Florida Statutes remains unchanged. The law says, in part:

  • Patients have a right to have access to any records made or received in the course of business by a healthcare facility or healthcare provider relating to any adverse medical incident.
  • This section does not repeal or otherwise alter any existing restrictions on the discoverability or admissibility of records relating to adverse medical incidents otherwise provided by law.
  • Except as otherwise provided by act of the Legislature, records of adverse medical incidents, including any information contained therein, obtained under s. 25, Art. X of the State Constitution, are not discoverable or admissible into evidence and may not be used for any purpose, including impeachment, in any civil or administrative action against a healthcare facility or healthcare provider. This includes information relating to performance or quality improvement initiatives and information relating to the identity of reviewers, complainants, or any person providing information contained in or used in, or any person participating in the creation of the records of adverse medical incidents. (Florida Statues, 2015).

Current Reporting Requirements

Florida requires that all licensed healthcare facilities establish an internal risk management program that includes:

  • The investigation and analysis of the frequency and causes of general categories and specific types of adverse incidents to patients
  • The development of appropriate measures to minimize the risk of adverse incidents to patients
  • The analysis of patient grievances that relate to patient care and the quality of medical services
  • A system for informing a patient or an individual identified pursuant to state law that the patient was the subject of an adverse incident
  • The development and implementation of an incident reporting system . . . [that requires all agents and employees to report] . . . adverse incidents to the risk manager . . . within 3 business days after their occurrence (Florida Statutes, 2015a).

Details of these sections contain requirements for licensing and training; any specific limitations, definitions of reportable events; and the encouragement of innovative solutions to the problem of medical errors. Additional sections of state law stipulate facility reporting requirements, and requires that the Agency for Health Care Administration (AHCA) post summary reports and trend analyses, covering the eight most serious adverse incidents at least quarterly as well as an annual report of all adverse incidents (Florida Statutes, 2015a).

In addition, a separate section of state law requires the Florida Agency for Healthcare Administration to collect data on hospital-acquired infections (Florida Statues, 2015a). Florida became the first state to publish a hospital-specific report on hospital-acquired infections (HAIs) in 2005. However, a March 2010 review by the Committee to Reduce Infection Deaths noted that the Florida reports were disappointing due to weaknesses in data collection, detail, and methodology (RID, 2011).

In 2011 the Florida Department of Health announced it received funding from the American Recovery and Reinvestment Act to develop a Healthcare-Associated Infection Prevention Program intended to help monitor and prevent these infections. Its status on infection rates as compared to the national baseline is accessible from the CDC (CDC, 2015a).


Florida’s Progress Combating HAIs

image: florida hai progress

Source: CDC, 2015. Click here or on the image to view the full-size graphic.

Types of Medical Errors


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.

Institute of Medicine, 1999
To Err is Human: Building a Safer Health System


There are many ways that medical care can go wrong. Errors can be related to the administration of medications, laboratory testing, infections occurring within the healthcare setting, surgery, or an environment contributing to a patient fall.

A number of healthcare organizations and government agencies have lists of medical errors on which they focus, but the seven we will discuss appear as hot-button indictors across most oversight organizations and are the ones most commonly encountered:

  1. Medication events (including adverse drug events/reactions)
  2. Healthcare-associated infections
  3. Surgical errors
  4. Laboratory errors
  5. Patient Falls
  6. Pressure sores
  7. Documentation/computer errors (NQF, 2011; AHRQ, 2015; CMS, 2014; Joint Commission, 2015; NHSN, 2015; CDC, 2014)

Medication Events

According to Preventing Medication Errors, the final report of a joint project involving the Institute of Medicine and others, there are 1.5 million preventable adverse medication events in the United States each year costing as much as $3.5 billion annually, making medication errors the most common of all medical errors.

The report notes a comprehensive study found an administration error rate of 11%. With a typical hospital patient receiving an average of 10 doses of medication each day, he or she could be subjected to at least one administration error per day (IOM, 2007).

Some of the most common causes of medication errors are:

  • Incomplete patient information, with the healthcare professional not knowing about allergies and other medications the patient is using
  • Miscommunication between physicians, pharmacists, and other healthcare professionals. For example, drug orders can be communicated incorrectly because of poor handwriting.
  • Name confusion from drug names that look or sound alike
  • Confusing drug labeling
  • Identical or similar packaging for different doses
  • Drug abbreviations that can be misinterpreted (FDA, 2012)

Adverse drug events (ADEs) cause an estimated 700,000 emergency department visits each year, and the CDC notes that the numbers of ADEs will likely grow due to: development of new medications, discovery of new uses for older medications, an aging American population, increase in the use of medications for disease prevention, and increased coverage for prescription medications (CDC, 2012).

Medication Errors

In 2011 the National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) urged medication error researchers, software developers, and institutions to use this standard definition to identify errors:

A medication error is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer. Such events may be related to professional practice, healthcare products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use (NCCMERP, 2014).

Not all medication errors result in harm to the patient. For example, if the dosage or route were prescribed incorrectly but the error was caught prior to administration (often called a “near miss”), there was no patient harm. That said, any type of medication error must be tracked so preventions can be developed, regardless of whether a patient was harmed or not.

Adverse Drug Events (ADEs)

An adverse drug event (ADE) is “an injury resulting from the use of a drug.” However, not all adverse drug events are the result of errors. According to the VA, “adverse drug events may result from medication errors but most do not” (USDVA, 2006).

ADEs are a serious public health problem, and are a leading cause of injury and death. ADEs account for an estimated one-third of hospital adverse events and approximately 280,000 hospital admissions annually (ODPHP, 2014).

According to the federal Office of Disease Prevention and Health Promotion, ADEs are responsible for a staggering number of harmful patient impacts.

In inpatient settings, ADEs:

  • Account for an estimated 1 in 3 of all hospital adverse events
  • Affect about 2 million hospital stays each year
  • Prolong hospital stays by 1.7 to 4.6 days

In outpatient settings, ADEs account annually for:

  • Over 3.5 million physician office visits
  • An estimated 1 million emergency department visits
  • Approximately 125,000 hospital admissions (ODPHP, 2014)

In addition, the Centers for Disease Control and Prevention (CDC) said ADEs are responsible for $3.5 billion in extra medical expenses as well as 40% of preventable ambulatory care costs (CDC, 2012).

Adverse Drug Reactions (ADRs)

Adverse drug reactions (ADRs) are unintended negative responses or harm caused during the normal use of a medication. ADRs can be an allergic response, such as hives after taking antibiotics, or a side effect such as stomach upset with aspirin (USDVA, 2006).

While all adverse drug reactions are adverse drug events, not all adverse drug events are adverse drug reactions. A patient given the wrong medication is an adverse drug event but not an adverse drug reaction because the medication in question was not used as it was intended. The figure below helps to clarify how the medication-related errors differ and relate to one another.


Adverse Drug Events vs. Reactions

Source: ODPHP, 2014.


Adverse drug reactions are a leading cause of injury and death; it is estimated they cause 100,000 deaths annually in the United States (FDA, 2014).

According to the Institute of Medicine, more than 2 million serious ADRs occur each year, 350,000 in nursing homes alone. In recent years the number of medications prescribed to patients has increased dramatically and, not surprisingly, adverse drug reactions have also increased. “Whereas a patient admitted to the hospital typically undergoes one—or even no—surgical procedure, virtually everyone gets bombarded with an array of medications the whole time they’re there” (FDA, 2014; Wachter & Shojania, 2004).

There are three main causes for adverse reactions:

  • As many as two-thirds of all patient visits to a doctor result in a prescription, and there are more drugs and combinations of drugs being used than ever before.
  • More than 4 billion prescriptions were filled in 2014 at retail pharmacies alone, nearly 10 prescriptions per person in the United States.
  • The rate of ADRs increases exponentially when a patient is taking four or more medications (FDA, 2014; KFF, 2014).

The drug approval process may also play a role in the increase of adverse drug reactions. A drug that is tested in only a few thousand people may have an excellent safety profile in those patients, but some drugs require many more exposures to detect an adverse reaction—particularly reactions that occur with low frequencies.

According to the U.S. Food and Drug Administration (FDA) learning module, “Preventable Adverse Drug Reactions: A Focus on Drug Interactions,” most drugs are approved for use by the FDA with an average of only 1,500 patient exposures and tested for relatively short period of time. A few million patients make take a new drug before the low-frequency adverse reactions are identified. For drugs that cause rare toxicity, the toxicity will only be detected after use by many more thousands of patients (FDA, 2014).

Specific Preventive Measures

Naming, Labeling, Packaging, and Abbreviations

The FDA has a seven-part role in reducing and preventing medication errors:

  • Drug name review. To minimize confusion between drug names that look or sound alike, the FDA reviews about 400 brand names a year before they are marketed, and about one-third are rejected.
  • Drug labels. Over-the-counter (OTC) medications require “standardized drug facts labels” and improved inserts in prescription medications for healthcare professionals.
  • Drug labeling and packaging. Works with drug companies to reduce problems stemming from labels and packages that are similar to one another or show poor product design.
  • Bar code label rule. Since 2004 certain drugs and biologics must have bar codes as part of their labels. When used with scanners and computerized patient information systems these help ensure the right dose of the right drug is given to the right patient at the right time.
  • Error analyses. Reviews about 1,400 reports of med errors every month.
  • Guidances for industry. Three new guidance statements are being reviewed regarding trade name development, pitfalls of drug labeling, and best test practices for drug naming.
  • Public education. Helps educate the public through various models about preventing medical errors. (FDA, 2009)

In 2006 the FDA and Institute for Safe Medication Practices (ISMP) have launched a national education campaign to eliminate the use of ambiguous medical abbreviations that are frequently misinterpreted and lead to mistakes resulting in patient harm. The campaign seeks to promote safe practices among those who communicate medical information (FDA, 2006).

The FDA recommends that clinicians review the Institute for Safe Medical Practices’ List of Error-Prone Abbreviations, Symbols and Dose Designation as shown in the following tables.


**These abbreviations are included on The Joint Commission’s “minimum list” of dangerous abbreviations, acronyms, and symbols that must be included on an organization’s “Do Not Use” list, effective January 1, 2004. Visit for more information about this Joint Commission requirement.
Source: Institute for Safe Medical Practices (ISMP), 2015.

Dangerous Abbreviations


Intended Meaning





Mistaken as “mg”

Use “mcg”


Right ear, left ear, each ear

Mistaken as OD, OS, OU (right eye, left eye, each eye)

Use “right ear,” “left ear,” or “each ear”


Right eye, left eye, each eye

Mistaken as AD, AS, AU (right ear, left ear, each ear)

Use “right eye,” “left eye,” or “each eye”



Mistaken as “BID” (twice daily)

Use “bedtime”


Cubic centimeters

Mistaken as “u” (units)

Use “mL”


Discharge or discontinue

Premature discontinuation of medications if D/C (intended to mean “discharge”) has been misinterpreted as “discontinued” when followed by a list of discharge medications

Use “discharge” and “discontinue”



Mistaken as “IV” or “intrajugular”

Use “injection”



Mistaken as “IM” or “IV”

Use “intranasal” or “NAS”






At bedtime, hours of sleep

Mistaken as bedtime


Mistaken as half-strength

Use “half-strength” or “bedtime”


International unit

Mistaken as IV (intravenous) or 10 (ten)

Use “units”

o.d. or OD

Once daily

Mistaken as “right eye” (OD-oculus dexter), leading to oral liquid medications administered in the eye

Use “daily”


Orange juice

Mistaken as OD or OS (right or left eye); drugs meant to be diluted in orange juice may be given in the eye

Use “orange juice”

Per os

By mouth, orally

The “os” can be mistaken as “left eye” (OS-oculus sinister)

Use “PO,” “by mouth,” or “orally”

q.d. or QD**

Every day

Mistaken as q.i.d., especially if the period after the “q” or the tail of the “q” is misunderstood as an “i”

Use “daily”


Nightly at bedtime

Mistaken as “qhr” or every hour

Use “nightly”


Nightly or at bedtime

Mistaken as “qh” (every hour)

Use “nightly” or “at bedtime”

q.o.d. or QOD**

Every other day

Mistaken as “q.d.” (daily) or “q.i.d.” (four times daily) if the “o” is poorly written

Use “every other day”



Mistaken as q.i.d. (four times daily)

Use “daily”

q6PM, etc.

Every evening at 6 PM

Mistaken as every 6 hours

Use “daily at 6 PM” or “6 PM daily”

sub q


SC mistaken as SL (sublingual); SQ mistaken as “5 every;” the “q” in “sub q” has been mistaken as “every” (e.g., a heparin dose ordered “sub q 2 hours before surgery” misunderstood as every 2 hours before surgery)

Use “subcut” or “subcutaneously”


Sliding scale (insulin) or ½ (apothecary)

Mistaken as “55”

Spell out “sliding scale;” use “one-half” or ½


Sliding scale regular insulin

Mistaken as selective-serotonin reuptake inhibitor

Spell out “sliding scale (insulin)”


Sliding scale insulin

Mistaken as Strong Solution of Iodine (Lugol’s)

Spell out “sliding scale (insulin)”


One daily

Mistaken as “tid”

Use “1 daily”

TIW or tiw

TIW: 3 times a week

TIW mistaken as “3 times a day” or “twice in a week”

Use “3 times weekly”

U or u**


Mistaken as the number 0 or 4, causing a 10-fold overdose or greater (e.g., 4U seen as “40” or 4u seen as “44”); mistaken as “cc” so dose given in volume instead of units (e.g., 4u seen as 4cc)

Use “unit”


As directed (“ut dictum”)

Mistaken as unit dose (e.g., diltiazem 125 mg IV infusion “UD” misinterpreted as meaning to give the entire infusion as a unit [bolus] dose)

Use “as directed”


**These abbreviations are included on The Joint Commission’s “minimum list” of dangerous abbreviations, acronyms, and symbols that must be included on an organization’s “Do Not Use” list, effective January 1, 2004. Visit for more information about this Joint Commission requirement.
Source: Institute for Safe Medical Practices (ISMP), 2015.

Error-Prone Dose Designations

Dose Designations and Other Information

Intended Meaning



Trailing zero after decimal point (e.g., 1.0 mg)**

1 mg

Mistaken as 10 mg if the decimal point is not seen

Do not use trailing zeros for doses expressed in whole numbers

“Naked” decimal point (e.g., .5 mg)**

0.5 mg

Mistaken as 5 mg if the decimal point is not seen

Use zero before a decimal point when the dose is less than a whole unit

Abbreviations such as mg. or mL. with a period following the abbreviation




The period is unnecessary and could be mistaken as the number 1 if written poorly

Use mg, mL, etc. without a terminal period

Drug name and dose run together (especially problematic for drug names that end in “l” such as Inderal40 mg; Tegretol300 mg)

Inderal 40 mg

Mistaken as Inderal 140 mg

Place adequate space between the drug name, dose, and unit of measure

Tegretol 300 mg

Mistaken as Tegretol 1300 mg

Numerical dose and unit of measure run together (e.g., 10mg, 100mL)




The “m” is sometimes mistaken as a zero or two zeros, risking a 10- to 100-fold overdose

Place adequate space between the dose and unit of measure

Large doses without properly placed commas (e.g., 100000 units; 1000000 units)

100,000 units

100000 has been mistaken as 10,000 or 1,000,000

Use commas for dosing units at or above 1,000, or use words such as 100 “thousand” or 1 “million” to improve readability

1,000,000 units

1000000 has been mistaken as 100,000


**These abbreviations are included on The Joint Commission’s “minimum list” of dangerous abbreviations, acronyms, and symbols that must be included on an organization’s “Do Not Use” list, effective January 1, 2004. Visit for more information about this Joint Commission requirement.
Source: Institute for Safe Medical Practices (ISMP), 2015.

Error-Prone Drug Name Abbreviations

Drug Name Abbreviations

Intended Meaning





Not recognized as acetaminophen

Use complete drug name



Mistaken as cytarabine (ARA C)

Use complete drug name


zidovudine (Retrovir)

Mistaken as azathioprine or aztreonam

Use complete drug name


Compazine (prochlorperazine)

Mistaken as chlorpromazine

Use complete drug name



Mistaken as diphtheria-pertussis-tetanus (vaccine)

Use complete drug name


Diluted tincture of opium, or deodorized tincture of opium (Paregoric)

Mistaken as tincture of opium

Use complete drug name


hydrochloric acid or hydrochloride

Mistaken as potassium chloride (The “H” is misinterpreted as “K”)

Use complete drug name unless expressed as a salt of a drug



Mistaken as hydrochlorothiazide

Use complete drug name



Mistaken as hydrocortisone (seen as HCT250 mg)

Use complete drug name


magnesium sulfate

Mistaken as morphine sulfate

Use complete drug name

MS, MSO4**

morphine sulfate

Mistaken as magnesium sulfate

Use complete drug name



Mistaken as mitoxantrone

Use complete drug name



Mistaken as patient controlled analgesia

Use complete drug name



Mistaken as mercaptopurine

Use complete drug name


Tylenol with codeine No. 3

Mistaken as liothyronine

Use complete drug name



Mistaken as tetracaine, Adrenalin, cocaine

Use complete drug name



Mistaken as “TPA”

Use complete drug name


zinc sulfate

Mistaken as morphine sulfate

Use complete drug name

Stemmed Drug Names

Intended Meaning



“Nitro” drip

nitroglycerin infusion

Mistaken as sodium nitroprusside infusion

Use complete drug name



Mistaken as Norflex

Use complete drug name

“IV Vanc”

intravenous vancomycin

Mistaken as Invanz

Use complete drug name


**These abbreviations are included on The Joint Commission’s “minimum list” of dangerous abbreviations, acronyms, and symbols that must be included on an organization’s “Do Not Use” list, effective January 1, 2004. Visit for more information about this Joint Commission requirement.
Source: Institute for Safe Medical Practices (ISMP), 2015.

Error-Prone Drug Symbols


Intended Meaning



dram symbol



Symbol for dram mistaken as “3”

Use the metric system

minim symbol


Symbol for minim mistaken as “mL”

Use the metric system


For three days

Mistaken as “3 doses”

Use “for three days”

> and <

Greater than and less than

Mistaken as opposite of intended; mistakenly use incorrect symbol; “< 10” mistaken as “40”

Use “greater than” or “less than”

/ (slash mark)

Separates two doses or indicates “per”

Mistaken as the number 1 (e.g. “25 units/10 units” misread as “25 units and 110 units”

Use “per” rather than a slash mark to separate doses



Mistaken as “2”

Use “at”



Mistaken as “2”

Use “and”


Plus or and

Mistaken as “4”

Use “and”



Mistaken as a zero (e.g., q2° seen as q 20

Use “hr,” “h,” or “hour”

Φ or Ø

zero, null sign

Mistaken as the numerals 4, 6, 8, and 9

Use 0 or zero, or describe intent using whole words


Black Box Warnings and High-Alert Medications

In 1995 the FDA established the Black Box Warning System to alert healthcare providers to drugs with increased risk for patients. These warnings are meant to be the strongest labeling requirement for drugs and drug products that can have serious adverse reactions or potential safety hazards, especially those that may result in death or injury. The black box warning appears on the label of a prescription to alert the patient and the provider about safety concerns, such as serious side effects or life-threatening risks.

Some black box warning drugs are Celebrex, warfarin, Avandia, Ritalin, estrogen-containing contraceptives, and most antidepressants. Although a large percentage of patients are prescribed medications with black box warnings, many do not receive the advised laboratory monitoring (Hughes & Blegen, 2008).

High-alert medications are those that have a higher likelihood of causing injury if misused. Some of these medications also have a higher volume of use than other medications.

Though medication mishaps with these high-alert drugs are no more frequent than other drugs, the consequences can be devastating (USDVA, 2015a). The top five high-alert medications are:

  • Insulin
  • Opiates and narcotics
  • Injectable potassium chloride concentrate
  • Intravenous anticoagulants
  • Sodium chloride solutions above 0.9 percent (Hughes & Blegen, 2008).

The National Center for Patient Safety promotes three principals to improve high-alert medication administration and distribution:

  • Eliminate the possibility of errors. Reduce the number of drugs on a facility’s formulary and the number of concentrations and volumes; remove high-alert drugs from critical areas.
  • Make errors visible. Have two individuals independently check the product to ensure it is correct, particularly when received in bulk; and have two individuals independently check equipment settings, as applicable, since some drugs are administered intravenously.
  • Minimize the consequence of errors. Minimize the size of vials or ampules in patient care areas to the dose commonly needed; reduce the total dose of drugs in a continuous IV drip bag; and reduce the concentration of the drugs when possible (USDVA, 2015a).

The Center also encourages standardized dosing procedures, careful screening of new products, and creating system redundancies, commonly known as “double checks” (USDVA, 2015a).

Healthcare-Associated Infections (HAIs)

Healthcare-associated infections (HAIs) are some of the most common complications associated with hospital care in the United States.

In the most recent HAI prevalence survey using 2011 data, researchers from the CDC found that about 1 in 25 hospital patients has at least one healthcare-associated infection. There were an estimated 722,000 HAIs in U.S acute care hospitals in 2011 (CDC 2014a).

More than half of all HAIs occurred outside of the intensive care unit and about 75,000 hospital patients with HAIs died during their hospitalization (CDC, 2014a). In fact, a 2013 study found that just five types of infections account for some $9.8 billion annually (Zimlichman et al., 2013).

The federal Office of Disease Prevention and Health Promotion (ODPHP), along with a consortium of other federal agencies including the U.S. Department of Health and Human Services (HHS) and CDC, has selected the following six HAIs as a target of its HAI Action Plan, an outcome of the National Action Plan to Prevent Health Care-Associated Infections: Road Map to Elimination set by HHS:

  • Surgical site infections
  • Central-line–associated bloodstream infections
  • Ventilator-associated pneumonia
  • Catheter-associated Urinary Tract Infections
  • Hospital-onset Clostridium difficile Infections
  • Hospital-onset Methicillin-resistant Staphylococcus aureus (MRSA) Bacteremia (ODPHP, 2013).

Surgical Site Infections (SSIs)

Surgical site infections (SSIs) are those that occur after surgery in the part of the body where the surgery took place. SSIs can sometimes be superficial, involving only the skin, but others are more serious and can involve tissues under the skin, organs, or implanted material. 

Common symptoms of a SSI include:

  • Redness and pain around near the surgical wound
  • Drainage of cloudy fluid from the surgical wound
  • Fever (CDC, 2010)

SSIs are the most common hospital-acquired infection, according to the CDC, accounting for more than 30% of all inpatient HAIs (NHSN, 2015). SSIs also account for an additional $22,000 in healthcare costs per case (Zimlichman et al., 2013).

SSIs are not only a national issue, but a local one as well. A 2012 study of 851 patients at nine hospitals in Jacksonville, Florida, found 51 had HAIs, 18 with surgical site infections. These accounted for the largest type of HAI in the study, or 35% among the patients with HAIs (Magill et al., 2012).

Preventing SSIs

To prevent surgical site infections, the CDC recommends:

Before surgery

  • Administer antimicrobial prophylaxis in accordance with evidence-based standards and guidelines.
  • Treat remote infections whenever possible before elective operations.
  • Avoid hair removal at the operative site unless it will interfere with the operation; do not use razors.
  • Use appropriate antiseptic agent and technique for skin preparation.  

During surgery

  • Keep operating room doors closed during surgery except as needed for passage of equipment, personnel, and the patient.

After surgery

  • Maintain immediate postoperative normothermia.
  • Protect primary closure incisions with sterile dressing.
  • Control blood glucose level during the immediate postoperative period for cardiac procedures.
  • Discontinue antibiotics according to evidence-based standards and guidelines.

Also consider:

Before surgery

  • Nasal screening and decolonization for Staphylococcus aureus carriers for select procedures (ie, cardiac, orthopedic, neurosurgery procedures with implants)
  • Screening preoperative blood glucose levels and maintaining tight glucose control

During surgery

  • Re-dose antibiotic at the 3-hour interval in procedures with duration >3 hours.
  • Adjust antimicrobial prophylaxis dose for obese patients (body mass index >30).
  • Use at least 50% fraction of inspired oxygen intraoperatively and immediately postoperatively in select procedure(s). (CDC, 2012a)

Central Line-Associated Bloodstream Infections

A central venous catheter, commonly called a “central line,” is an intravascular catheter that terminates at or close to the heart or one of the great vessels and is used for infusion, withdrawal of blood, or hemodynamic monitoring.

Patients who get a central line-associated bloodstream infection (CLABSI) have a fever and might also have red skin and soreness around the central line (CDC, 2011).

According to the National Healthcare Safety Network of the CDC, there are an estimated 30,100 CLABSIs in the United States each year, but other estimate the number of CLABSIs could be as high as 80,000 each year. These infections are usually serious infections typically causing an increase length of stay, increased costs, and risk of mortality (NHSN, 2015; Ranji et al., 2007).

Zimlichman and colleagues found CLABSIs could add as much as $45,814 in care on a per-case basis, making it the costliest HAI on average per case in the study (Zimlichman et al., 2013).

Several types of infections can occur with central lines. The skin at the insertion site of the catheter may become infected (this is called an exit-site infection), or the internal surface of the device itself may become colonized with bacteria, which occurs in 25% of catheters left in place for 5 days (Ranji et al., 2007).

The clinical significance of colonization, along with migration of skin flora along the external surface of the catheter, can lead to the most serious consequence of CLABSI—a bacteremic infection associated with the presence of a central venous catheter.

Central-line­associated bloodstream infections are estimated to result in an absolute increase in mortality of 10% to 30% for ICU patients, and the total yearly costs to the U.S. healthcare system can be as much as $2 billion (Ranji et al., 2007).

The good news is that prevention measures of CLABSIs are having an impact. The CDC’s 2015 HAI Progress Report, based on 2013 data, shows a 46% decrease in CLABSIs between 2008 and 2013 (CDC, 2015b).

Preventing CLABSIs

Healthcare providers can take the following steps to help prevent CLABSIs:

  • Perform hand hygiene.
  • Apply appropriate skin antiseptic.
  • Ensure that the skin prep agent has completely dried before inserting the central line.
  • Use all five maximal sterile barrier precautions:
    • Sterile gloves
    • Sterile gown
    • Cap
    • Mask
    • Large sterile drape
  • Once the central line is in place:
    • Follow recommended central line maintenance practices.
    • Wash their hands with soap and water or an alcohol-based hand rub before and after touching the line.
  • Remove a central line as soon as it is no longer needed. The sooner a catheter is removed, the less likely the chance of infection. (CDC, 2011)

Other interventions include use of aseptic technique for the insertion of all central venous catheters and use of 2% chlorhexidine gluconate solution for skin disinfection at the insertion site. Also, avoid insertion at the femoral site for nonemergency insertion. Routine removal and replacement of a central venous catheter over guidewire is explicitly discouraged (Ranji et al., 2007).

Ventilator-Associated Pneumonia (VAP)

Studies have estimated that more than 300,000 patients receive mechanical ventilation in the United States each year. These patients are at high risk for complications and poor outcomes, including death (NHSN, 2015).

Among the more serious complications is ventilator-associated pneumonia (VAP). The CDC defines VAP as “a pneumonia where the patient is on mechanical ventilation for >2 calendar days on the date of event, with day of ventilator placement being Day 1, AND the ventilator was in place on the date of event or the day before. If the patient is admitted or transferred into a facility on a ventilator, the day of admission is considered Day 1” (NHSN, 2015).

Patients with VAP can incur an additional $21,000 in costs, on average, and remain hospitalized for 7 to 9 excess days (AHRQ PFP, 2014; Ranji et al., 2007).

In 2011 the CDC said an estimated 157,000 healthcare-associated pneumonias occurred in acute care hospitals in United States (NHSN, 2015).

With statistics like these, we know VAP is an issue. Unfortunately, while there are good protocols to reduce the incidence, the efforts to measure—and therefore reduce—VAP have posed a problem.

The National Action Plan to Prevent Health Care-Associated Infections: Road Map to Elimination, issued by the Office of Disease Prevention and Health Promotion, an agency of HHS, noted the issue:

The 2009 HAI Action Plan identified ventilator-associated pneumonia (VAP) as a priority area for prevention, however did not specify a related measure and five-year reduction goal for national use due to the lack of an accepted, objective definition that could be used for multiple purposes, including national benchmarking and interfacility comparison. The HAI Action Plan will be shifting its focus to address the issue of ventilator-associated events (VAE) in adult patients.

Subject matter experts at the Critical Care Societies Collaborative, CDC, and other partner organizations have recently developed a new approach to VAE surveillance. Acknowledging the inaccuracies inherent in the diagnosis of VAP, the group focused instead on developing more objectively defined measures, resulting in a new proposed VAE surveillance definition algorithm (ODPHP, 2013).

Consequently, the National Healthcare Safety Network, a division of the CDC, made this statement in the Patient Safety Component Manual (modified April 2015):

A particular difficulty with many commonly-used VAP definitions, including the NHSN PNEU definitions (revised in 2002), is that they require radiographic findings of pneumonia. Evidence suggests that chest radiograph findings do not accurately identify VAP. The subjectivity and variability inherent in chest radiograph technique, interpretation, and reporting make chest imaging ill-suited for inclusion in a definition algorithm to be used for the potential purposes of public reporting, inter-facility comparisons, and pay-for-reporting and pay-for-performance programs. Another major difficulty with available VAP definitions is their reliance on specific clinical signs or symptoms, which are subjective and may be poorly or inconsistently documented in the medical record. . . .

The limitations of VAP surveillance definitions have implications for prevention. Valid and reliable surveillance data are necessary for assessing the effectiveness of prevention strategies. It is notable that some of the most effective measures for improving outcomes of patients on mechanical ventilation do not specifically target pneumonia prevention. (NHSN, 2015)

Preventing VAP

To prevent ventilator-associated pneumonia, healthcare providers can do the following things:

  • Keep the head of the patient’s bed raised between 30 and 45 degrees unless other medical conditions do not allow this.
  • Check the patient’s ability to breathe on own every day so that the patient can be taken off of the ventilator as soon as possible.
  • Clean hands with soap and water or an alcohol-based hand rub before and after touching the patient or the ventilator.
  • Clean the inside of the patient’s mouth on a regular basis.
  • Clean or replace equipment between use on different patients. (CDC, 2010a; Coffin et al., 2008; Krein et al., 2008)

Catheter-Associated Urinary Tract Infections

As many as 25% of hospitalized patients receive urinary catheters during their hospital stay, according to the CDC. Among UTIs acquired in the hospital, approximately 75% are catheter-associated urinary tract infections (CAUTIs) (CDC, 2015c).

Some of the common symptoms of a UTI are burning or pain in the lower abdomen, fever, burning during urination, or an increase in the frequency of urination. UTIs are one of the most common types of healthcare-associated infection and are most often caused by the placement or presence of a catheter in the urinary tract (CDC, 2010b).

Partnership for Patients, a public–private program with more than 8,000 partners and coordinated by CMS, found 290,000 CAUTIs in more than 32 million discharges in 2013, for a rate 8.8 per 1,000 discharges (AHRQ PfP, 2014).

We are making headway with this particular HAI; the 2013 findings represent a 28% reduction from the baseline 12.2 per 1,000 discharges in 2010 (AHRQ PfP, 2014).

Preventing CAUTIs

The CDC recommends the following practices to prevent CAUTIs:

  • Insert catheters only for appropriate indications.
  • Leave catheters in place only as long as needed.
  • Ensure that only properly trained persons insert and maintain catheters.
  • Insert catheters using aseptic technique and sterile equipment (acute care setting).
  • Follow aseptic insertion, maintain a closed drainage system.
  • Maintain unobstructed urine flow.
  • Comply with CDC hand hygiene recommendations and Standard Precautions.

Also consider:

  • Alternatives to indwelling urinary catheterization
  • Use of portable ultrasound devices for assessing urine volume to reduce unnecessary catheterizations
  • Use of antimicrobial/antiseptic-impregnated catheters (CDC, 2012a)

More detailed prevention procedures can be found in Guideline for Prevention of Catheter-Associated Urinary Tract Infections, 2009. The guideline emphasizes the proper use, insertion, and maintenance of urinary catheters in various healthcare settings. It also presents effective quality improvement programs that healthcare facilities can use to prevent CAUTIs.

Hospital-Onset C. difficile Infections

Infections caused by Clostridium difficile, a Gram-positive anaerobic bacillus, are characterized by watery diarrhea, fever, loss of appetite, nausea, and abdominal pain/tenderness (CDC, 2010c; CDC, 2015e).

C. difficile infections often occur as secondary infections after antibiotic therapy. It can be contracted in the community as well as in healthcare settings. The severity can range from unpleasant but benign to full-blown sepsis. It is spread through coughing and improper handwashing (NHSN, 2015).

C. difficile is shed in feces. Any surface, device, or material (eg, toilets, bathtubs, electronic rectal thermometers) that becomes contaminated with feces may serve as a reservoir for the spores. C. difficile spores are transferred to patients mainly via the hands of healthcare personnel who have touched a contaminated surface or item. C. difficile can live for long periods on surfaces (CDC, 2015e).

Since many patients in hospitals are immunocompromised, C. difficile poses a severe threat. In 2011 C. difficile was estimated to cause almost half a million infections in the United States, and 29,000 died within 30 days of the initial diagnosis (CDC, 2015f).

A prevalence study by a team of CDC researchers of more than 11,000 patients at 183 hospitals found C. difficile in 12% of the HAIs isolated, making it the most common pathogen found in the study (Magill et al., 2014).

While C. difficile can be deadly, protocols put in place by multiple public and private healthcare organizations are having an effect on the spread of the disease. The National and State Healthcare-Associated Infections Progress Report showed a 10% decrease in hospital-onset C. difficile infections between 2011 and 2013 (CDC, 2015b).

Preventing C. difficile Infections

To prevent C. difficile infections, healthcare providers should:

  • Clean their hands with soap and water or an alcohol-based hand rub before and after caring for every patient. This can prevent C. difficile and other germs from being passed from one patient to another on their hands.
  • Carefully clean hospital rooms and medical equipment that have been used for patients with C. difficile.
  • Use Contact Precautions to prevent C. difficile from spreading to other patients. Contact Precautions mean:
    • Whenever possible, patients with C. difficile will have a single room or share a room only with someone else who also has C. difficile.
    • Healthcare providers will put on gloves and wear a gown over their clothing while taking care of patients with C. difficile.
    • Visitors may also be asked to wear a gown and gloves.
    • When leaving the room, hospital providers and visitors remove their gown and gloves and clean their hands (CDC, n.d.).

The CDC also says healthcare facilities should consider the following:

  • Extend the use of Contact Precautions beyond duration of diarrhea (eg, 48 hours)
  • Presumptive isolation for symptomatic patients pending confirmation of C. difficile infection
  • Evaluate and optimize testing for C. difficile infection
  • Implement soap and water for hand hygiene before exiting room of a patient with C. difficile infection
  • Implement universal glove use on units with high C. difficile infection rates
  • Use EPA-registered disinfectants with sporicidal claim (eg, bleach) or sterilants for environmental disinfection
  • Implement an antimicrobial stewardship program (CDC, 2012a).


Superbugs, bacteria that are difficult to kill and are resistant to most antibiotics, pose a serious threat to healthcare (NIH, 2014).

Each year in the United States, at least 2 million people become infected with bacteria that are resistant to antibiotics and at least 23,000 people die each year as a direct result of these infections. Many more people die from other conditions that were complicated by an antibiotic-resistant infection (CDC, 2013).

Antibiotic-resistant infections can happen anywhere. Data show that most happen in the general community; however, most deaths related to antibiotic resistance happen in healthcare settings such as hospitals and nursing homes (CDC, 2013).

Three superbugs are of particular concern because of their virulence and prevalence:

  1. Methicillin-resistant Staphylococcus aureus
  2. Vancomycin-resistant Enterococcus
  3. Carbapenem-Resistant Enterobacteriaceae

These three have increased in prevalence in U.S. hospitals over the last three decades, and have important implications for patient safety. A primary reason for concern about these multidrug-resistant organisms is that options for treating patients with these infections are often extremely limited, and these types of infections are associated with increased lengths of stay, costs, and mortality (NHSN, 2015).

Methicillin-resistant S. aureus (MRSA)

Methicillin-resistant Staphylococcus aureus (MSRA) is the one of the most common HAIs, and there has been a dramatic increase in the number of MRSA-associated hospital stays since 2000. MRSA, often found in intensive care units, is associated with longer hospital stays and a higher likelihood of death (AHRQ, 2014).

MRSA causes a range of illnesses, from skin and wound infections to pneumonia and bloodstream infections that can cause sepsis and death. CDC estimates 80,461 invasive MRSA infections and 11,285 MRSA-related deaths occurred in 2011 (CDC, 2013).

Although MRSA is still a major patient threat, a CDC study published in the Journal of the American Medical Association, Internal Medicine, showed life-threatening MRSA infections that began in hospitals declined 54% between 2005 and 2011, with 30,800 fewer severe MRSA infections. In addition, the study showed 9,000 fewer deaths in hospital patients in 2011 versus 2005 (CDC, 2013).


image: MRSA chart

Source: CDC, 2013. Click here or on the image to view the complete and full-size version.


Vancomycin-resistant Enterococci (VRE)

Vancomycin-resistant enterococci are of great concern because they are not only resistant to one of the most powerful antibiotics available (vancomycin is considered an “antibiotic of last resort”) and therefore have little or no treatment options, but they also have a knack for passing on that resistance to other bacteria. In fact, there is evidence that VRE has passed on its vancomycin resistance to S. aureus, creating an emerging threat of vancomycin-resistant S. aureus (VRSA) (NIAID, 2009).

An estimated 20,000 vancomycin-resistant infections occur among hospitalized patients each year, with approximately 1,300 deaths attributed to these infections (CDC, 2013).

Drug-resistant Enterococci can cause HAIs of the bloodstream, surgical site, and urinary tract (NIAID 2009).

Carbapenem-Resistant Enterobacteriaceae (CRE)

Enterobacteriaceae resistant to carbapenem (an antibiotic of last resort) are particularly virulent. CREs have become resistant to all or nearly all the antibiotics we have today. An estimated 140,000 HAI Enterobacteriaceae infections occur in the United States each year; about 9,300 of these are caused by CRE. Almost half of hospital patients who get bloodstream infections from CRE bacteria die from the infection (CDC, 2013).

Unlike methicillin resistance in Staphylococcus aureus, which represents one resistance mechanism in one species of bacteria, Enterobacteriaceae include more than 70 different genera and many different mechanisms can lead to carbapenem resistance (CDC, 2015d).

Of particular concern are those strains that produce carbapenemase. These are currently believed to be primarily responsible for the increasing spread of CRE in the United States and have therefore been targeted for aggressive prevention (CDC, 2015d).

The CDC considers CRE “an immediate public health threat that requires urgent and aggressive action” (CDC, 2013).

Hand Hygiene: Best Practice to Prevent HAIs

Healthcare-associated infections, as dangerous and even deadly as they are, can be mitigated by one of the simplest methods of infection control—good hand hygiene.

Hand hygiene is considered the best preventive measure for all HAIs and is recommended universally as a key strategy to prevent HAIs of all types. Current recommendations encourage use of waterless, alcohol-based hand rubs (Ranji et al., 2007).

In several studies, handwashing with plain soap failed to remove certain pathogens from the hands of healthcare workers. Hand rubs with at least 60% concentration of alcohol were remarkably good at killing most pathogens encountered in healthcare settings (WHO, 2009).

Healthcare providers should practice hand hygiene at key points in time to disrupt the transmission of microorganisms to patients. These include:

  • Before patient contact
  • After contact with blood, body fluids, or contaminated surfaces (even if gloves are worn)
  • Before invasive procedures
  • After removing gloves (wearing gloves is not enough to prevent the transmission of pathogens in healthcare settings) (CDC, 2014e)

Surgical Errors

According to an AHRQ-supported study, wrong-site surgery occurred at a rate of approximately 1 per 113,000 operations between 1985 and 2004. In July 2004 the Joint Commission enacted the Universal Protocol, which requires performing a time out prior to beginning surgery, a practice that has been shown to improve teamwork and decrease the overall risk of wrong-site surgery. Developed through expert consensus on principles and steps for preventing wrong-site, wrong-procedure, and wrong-person surgery, the Universal Protocol applies to all accredited hospitals, ambulatory care, and office-based surgery facilities.

Wrong-site, wrong-procedure, and wrong-patient errors are all now considered “never events” (medical errors that should never occur) by the National Quality Forum (NQF) and “sentinel events” (events resulting in death, permanent harm, or severe temporary harm, and intervention required to sustain life, among other events) by the Joint Commission. CMS has not reimbursed healthcare providers for any costs associated with these surgical errors since 2009 (PSNet, n.d.; PSNet 2014; Joint Commission, 2014).

In 2011 NQF and other agencies added “unintended retention of a foreign object in a patient after surgery or other procedure” to its list of never events for surgeries, and this is also among the hospital-acquired conditions for which CMS will not reimburse (CMS, 2014).

Universal Protocol: Best Practice to Prevent Surgical Errors

To address the problem of preventable surgical errors, the Joint Commission issued its Universal Protocol on July 1, 2004, and it has become a mandatory patient safety standard in healthcare ever since. The protocol consists of the following three components:

  1. A pre-procedure verification process
  2. Surgical site marking
  3. Surgical “time out” immediately prior to starting the procedure

The surgical site must be marked and visible after prepping and draping of the patient. Using the surgical time-out as a “reflective pause or a preoperative briefing” involves the surgeons, anesthesiologists, nurse anesthetists, quality control specialists, and administrators. Recent studies show the surgical time-out is an effective quality control measure (Stahel et al., 2009; Joint Commission, 2015a).

Laboratory Errors

An estimated 10 billion laboratory tests are performed each year in the United States, which influence approximately 70% of medical decisions (U.S. Army, 2013; MMWR, 2005). In fact, emergency departments order clinical laboratory tests in more than 41% of all visits, family physicians order tests in 29% of visits, and general internists in 38% of visits (Epner et al., 2013).

CLIA and Laboratory Errors

Nearly 30 years ago, the CDC, CMS and the FDA developed the Clinical Laboratory Improvement Amendments of 1988 (CLIA), a sweeping set of regulations for all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. A critical component of these regulations was quality control. Final regulations were published in 2003 (CDC, 2015g).

CLIA urges laboratories to develop an individualized quality control plan addressing five areas for assessing risk: specimen, test system, reagents, environment, and testing personnel (see table below) (CLIA, 2014).


Source: CLIA, 2014. Go to the CLIA brochure to view the original.

Potential Sources of Error for the five
Risk Assessment Components


  • Patient preparation
  • Specimen collection
  • Specimen labeling
  • Specimen storage, preservation, and stability
  • Specimen transportation
  • Specimen processing
  • Specimen acceptability and rejection
  • Specimen referral


  • Inadequate sampling
  • Clot detection capabilities
  • Capabilities for detection of interfering substances (e.g., hemolysis, lipemia, icterus, turbidity)
  • Calibration associated issues
  • Mechanical/electronic failure of test system
  • Optics
  • Pipettes or pipettors
  • Barcode readers
  • Failure of system controls and function checks
  • Built-in procedural and electronic controls (internal controls)
  • External or internal liquid quality control (assayed vs. unassayed)
  • Temperature monitors and controllers
  • Software/Hardware
  • Transmission of data to LIS
  • Result reporting


  • Shipping/Receiving
  • Storage condition requirements
  • Expiration Date (may differ based on storage requirements)
  • Preparation


  • Temperature
  • Airflow/ventilation
  • Light intensity
  • Noise and vibration
  • Humidity
  • Altitude
  • Dust
  • Water
  • Utilities (Electrical failure/power supply variance or surge)
  • space


  • Training
  • Competency
  • Education and experience
  • Staffing


Laboratory testing is often broken into three stages: pre-analytic, analytic, and post-analytic (CLIA, 2014). Studies have shown nearly 70% of errors occur in the pre-analytic phase encompassing test requests, patient and specimen identification, specimen collection, transport, accessioning or processing (Kaushik & Green, 2014).

Poor communication between laboratory and healthcare professionals is the main issue affecting quality in the pre- and post-analytic phases, and researchers note few in either group receive specific training in good communication techniques. Issues of test choice, patient information, specimen adequacy (in pre phase), and values and interpretation (in post phase) can involve many different healthcare professionals, and poor communication among them can result in errors, patient harm, and “inefficient and ineffective use of healthcare resources.” Errors also occur when clinicians choose and order tests; during specimen collection, including mislabeling, improper collection, and specimen contamination; in laboratory processing; and in results analysis and reporting (Wolcott et al., 2008).

Impact of Waived Tests on Laboratory Testing

As part of CLIA, some simple, low-risk tests were waived from laboratory quality requirements and performed with no routine regulatory oversight in physicians’ offices and various other locations (MMWR, 2005).

In 1993 CLIA waived nine such tests; today there are more than 5,400 waived test systems and 119 analytes, according to the Commission on Office Laboratory Accreditation (COLA), an independent laboratory accreditation agency recognized by both CMS and the Joint Commission (COLA, 2013).

Although by law waived tests should have insignificant risk for erroneous results, these tests are not completely error-proof and are not always used in settings that employ a systems approach to quality and patient safety. Errors can occur anywhere in the testing process, particularly when the manufacturer’s instructions are not followed, and when testing personnel are not familiar with all aspects of the test system and how testing is integrated into the facility’s workflow (COLA, 2013; MMWR, 2005).

Although data have not been systematically collected on patient outcomes with waived testing, adverse events can occur. Some waived tests have potential for serious health impacts if performed incorrectly. For example, results from waived tests can be used to adjust medication dosages, such as prothrombin time testing in patients undergoing anticoagulant therapy or glucose monitoring in diabetics. In addition, erroneous results from diagnostic tests, such as those for human immunodeficiency virus (HIV) antibody, can have unintended consequences (MMWR, 2005).

In its white paper, “Federal Government Questions Quality in Waived Testing,” COLA wrote regarding the CDC’s 2005 Morbidity & Mortality Weekly Report, “Good Laboratory Practices” survey:

According to a report from the Centers for Disease Control and Prevention, 31% to 43% of waived labs do not follow manufacturer’s instructions.

Some other examples of notable problems among the more than 150,000 waived testing sites in the U.S. include:

  • More than 20% do not routinely check the product insert or instructions for changes to the information (consider the implications of an ignored new sampling technique for a Rapid HIV test)
  • More than 20% do not perform quality control testing as specified by manufacturer’s instructions (consider the implications of an uncontrolled prothrombin time test)
  • Nearly half do not document the name, lot number, and expiration dates for tests performed (consider the implications of a massive recall of problematic test kits). (COLA, 2013)

What’s more, the Morbidity & Mortality report also found that some 5% were performing tests that were not waived (MMWR, 2005).

Preventing Laboratory Errors

Although laboratory medicine has had long a history of formalized approaches of mitigating errors, most laboratory quality control programs focus on reducing testing errors as opposed to a systems approach preventing diagnostic harm to patients (Epner et al., 2013).

Several studies are reviewing an outcomes-based approach to reducing and preventing errors. Epner and colleagues suggest five causes that, taken together, may explain all-important sources of diagnostic error and harm related to the testing process (see box below). “While occurrences of the five causes will not always result in diagnostic error, patient harm related to diagnostic testing is highly likely to stem from one of these five causes” (Epner et al., 2013).


Five Causes of Diagnostic Error and Harm

Five causes taxonomy of testing-related diagnostic error:

  • An inappropriate test is ordered.
  • An appropriate test is not ordered.
  • An appropriate test result is misapplied.
  • An appropriate test is ordered, but a delay occurs somewhere in the total testing process.
  • The result of an appropriately ordered test is inaccurate.

Source: Epner, Gans, & Graber, 2013.


Epner and colleagues suggest research into new interventions is needed, and should take into account the following questions:

  • What specific measures can be developed and validated to assess and monitor the harm of testing-related diagnostic error?
  • How often and under what circumstances do the five types of errors proposed lead to harm associated with an erroneous diagnosis, a missed diagnosis, or a delay in diagnosis?
  • What practices would optimize the appropriate ordering of laboratory tests and application of laboratory test results to improve patient outcomes?

“Clearly, laboratorians and clinicians should forge stronger links between diagnostic testing and patient outcomes. Without those links, the clinical laboratory will continue to be driven primarily by cost, volume, and process measures, similar to the way a factory manages inputs and outputs,” the researchers wrote (Epner et al., 2013).

Patient Falls

Falls among older Americans are a serious issue. The CDC reports falls by older adults incur $34 billion in direct medical costs. Annually, emergency departments treat about 2.5 million nonfatal fall injuries among older adults; more than 30%, or about 734,000 of these patients, have to be hospitalized (CDC, 2015h).

Falls within care settings are especially concerning. One study found that patients whose falls resulted in serious injury added more than $13,000 in care costs per episode and had a length of stay increased by more than 6 days (Wong et al., 2011).

By far the most alarming, the Joint Commission Center for Transforming Healthcare said that some 11,000 fatalities result from patient falls inside hospitals (DuPree, 2014).

Injuries can occur in as many as 44% of acute inpatient falls. Serious injuries from falls, such as head injuries or fractures, occur less frequently (2% to 8%), but result in approximately 90,000 serious injuries across the United States each year. Fall-related deaths in the inpatient environment are a relatively rare occurrence. Although less than 1% of inpatient falls result in death, this translates to approximately 11,000 fatal falls in the hospital environment per year nationwide. Since falls are considered preventable, fatal falls and fall-related injuries should never occur while a patient is under hospital care (Hughes & Blegen, 2008).

In the long-term care setting, 29% to 55% of residents are reported to fall during their stay. In this group, injury rates are reported to be as high as 20%, twice that of community-dwelling elders. The increase in injury rates is likely because long-term care residents are more vulnerable than those who can function in the community. The current number of long term-care fatal falls has not been estimated; however, there were 16,000 nursing homes in the United States caring for 1.5 million residents in 2004. This population will likely grow in the coming years, thus fall and injury prevention remains of utmost concern (Hughes & Blegen, 2008).

Preventing Patient Falls

Inpatient fall prevention has been an area of concern for almost 50 years. Traditional hospital-based incident reports consider all inpatient falls to be avoidable, and therefore falls are classified as adverse events (Hughes & Blegen, 2008).

Despite volumes of research and prevention protocols, some have concluded that falls are never completely unavoidable (Waters et al., 2015; Champaneria et al, 2014; Lohse et al., 2012). Indeed, eldercare expert Dr. Sharon Inouye concluded that perhaps just 20% of falls could be mitigated and that quality measures should focus on safe mobility rather than just patient falls (Inouye et al., 2009).

Despite these grim perspectives, all researchers noted that falls prevention of some kind must continue. To aid patient care centers, several large agencies have developed comprehensive fall prevention protocols.

Joint Commission Center for Transforming Healthcare

The Joint Commission released its Targeted Solutions Tool for Patient Falls with Injury, in August 2015. The tool is an innovative application that guides healthcare organizations through a step-by-step process to accurately measure their organization’s actual performance, identify their barriers to excellent performance, and direct them to proven solutions that are customized to address their particular barriers. According to the Commission, organizations that followed its standardized approach reduced the rate of patient falls by 35% and falls with injury by 62% (JCC, 2015).

Agency for Healthcare Research and Quality

AHRQ released in 2008 its mammoth text, Patient Safety and Quality: An Evidence-Based Handbook for Nurses. The guide includes a chapter specific to patient falls in different care settings, with a discussion of fall risk assessment tools and prevention strategies, such as floor mats (see table below).


Source: Hughes & Blegen, 2008.

Recommendations for Acute and Long-Term Care

Evidence-based practice recommendations

Research implications

Fall Prevention

Educate staff about safety care.

Train medical team, including students and residents, for fall-injury risk assessment and post fall assessment.

Examine impact of safety education across interdisciplinary team.


Use alarm devices.

Examine impact of alarms on caregiver satisfaction.

Monitor medication side effects and adjust as needed.

Examine effect of computerized decision support for medication management.

Adjust environment (eg, design rooms to promote safe patient movement).

Examine cost effectiveness of environmental adjustments.

Provide exercise interventions (eg, Tai Chi) for long-term care patients.

Examine usefulness of exercise interventions for acute care patients.

Provide toileting regimen for confused patients (eg, check patients every 2 hours).

Study barriers to maintaining and sustaining monitoring activities.

Monitor and treat calcium and vitamin D levels for long-term care patients.

Examine effects of calcium and vitamin D management for acute care patients.

Treat underlying disorders such as syncope, diabetes, and anemia.

Examine constellations of disorders that might precipitate falls.


Injury Prevention

Limit restraints use.

Identify methods to overcome barriers to restraints reduction.

Lower bedrails.

Study efficacy of environmental changes.

In addition to fall rates, monitor injury rates.

Establish fatal fall rates across settings.

Use hip protectors for geriatrics and long-term care.

Identify methods to overcome barriers to use of hip protectors.

Use floor mats.

Examine effect of safety flooring.

Monitor prothrombin time, international normalized ration (PT/INR) for patients at risk for falling.

Identify safety measures for bleeding-injury prevention.

Ensure post fall assessment.

Examine barriers to post fall assessment.

Use bisphosphonates for patients with documented osteoporosis.

Explore safety of long-term use of bisphosphonates.


AHRQ also published its “2013 Preventing Falls in Hospitals: A Toolkit for Improving Quality of Care,” which discusses the development of a complete program for hospitals, including such practices rounding protocols (AHRQ, 2013).

Other Approaches to Preventing Falls

Stemming from a study of seven participating acute-care centers, methods to reduce falls included adopting an organizational culture of commitment to fall safety, engaging patients and families in the fall safety process, utilizing a validated falls assessment tool, hourly rounding, among other protocols. Targeted solutions included implementing a standardized assessment tool and video monitoring on non-compliant patients (DuPree et al., 2014).

Tens of thousands of patients fall in healthcare facilities every year and many of these falls result in moderate to severe injuries. Find out how the participants in the Center for Transforming Healthcare’s seventh project are working to keep patients safe from falls.


Keeping Patients Safe From Falls (3:58)

The Joint Commission (2012).


Pressure Ulcers

Pressure ulcers, sometimes called decubitus ulcers, pressure sores or bedsores, are areas of damaged skin caused by staying in one position for too long. They commonly form where bones are close to the skin, such as ankles, back, elbows, heels, and hips. Patients are at risk if they are bedridden, use a wheelchair, or are unable to change their position. Pressure sores can cause serious infections, some of which are life-threatening (MedLine Plus, 2014).

Pressure ulcers, which can occur in healthcare settings or at home, affect more than 2.5 million people annually (CDC, 2011a).

Pressures ulcers are often associated with nursing homes and long-term skilled care facilities, but some 60,000 deaths occur each year from complications due to hospital-acquired pressure ulcers (Sullivan & Schoelles, 2013; NQMC, 2012).

The estimated cost of managing a single full-thickness pressure ulcer is as high as $70,000, and the total cost for treatment of pressure ulcers in the United States is estimated at $11 billion per year. Within care settings, pressure ulcer incidence rates vary considerably, ranging from 0.4% to 38% in acute care, from 2.2% to 23.9% in long-term care, and from 0% to 17% in home care (NQMC, 2012).

But unlike many other medical errors, the incidence of pressure ulcers is climbing—perhaps by as much as 80% from 1995 to 2008 (Sullivan & Schoelles, 2013).

The prevention of pressure ulcers is on the NQF’s list of Serious Reportable Events and encompasses several nationally endorsed measures (NQF, n.d.).

Preventing Pressure Ulcers

Basic preventions for pressure ulcers involve:

  • Keeping skin clean and dry
  • Changing position every two hours
  • Using pillows and products that relieve pressure (MedLine Plus, 2014)

In their large literature review, Sullivan and Schoelles suggested prevention measures include simplification and standardization of pressure ulcer interventions and documentation, involvement of multidisciplinary teams and leadership, use of designated skin champions, ongoing staff education, and sustained audit and feedback (Sullivan & Schoelles 2013).

In ARHQ’s “Preventing Pressure Ulcers in Hospitals Tool Kit,” the agency presents a broad scope plan, and recommends a multi-disciplinary approach:

No individual clinician working alone, regardless of how talented, can prevent all pressure ulcers from developing. Rather, pressure ulcer prevention requires activities among many individuals, including the multiple disciplines and multiple teams involved in developing and implementing the care plan. To accomplish this coordination, high-quality prevention requires an organizational culture and operational practices that promote teamwork and communication, as well as individual expertise. Therefore, improvement in pressure ulcer prevention calls for a system focus to make needed changes.

More specifically, ARHQ recommends a protocol that includes:

  • Comprehensive skin assessment
  • Standardized pressure ulcer risk assessment
  • Care planning and implementation to address areas of risk (ARHQ, 2014a)

Documentation Errors

Central to many types of medical errors are issues with documentation. While illegible physician handwriting is often regarded as a humorous cliché, it can have ramifications that are anything but humorous. Charting errors or omissions can have serious consequences.

Electronic medical records (EMRs) and more comprehensive systems known as electronic health records (EHRs) have grown exponentially in the last two decades, bolstered by several game-changing pieces of legislation. For all their efficiencies, electronic records are still subject to documentation and informational errors.

High-risk copy-and-paste errors, which are defined as mistakes with high potential risk for patient harm, fraud, or tort claim, have been reported in 10% of patient EMRs. Such errors can result in inaccuracies that can carry forward throughout the patient’s record (Hirschtick, 2012).

Cho and colleagues found that more than 50% medication orders entered through a computerized physician order/entry system had at least one error in a study at a 950-bed teaching hospital. Further, documentation errors occurred in 205 (82.7%) of 248 correctly performed administrations. When tracking incorrectly entered prescriptions, 93% of the errors were intercepted by nurses, but two-thirds of them were recorded as prescribed rather than administered (Cho et al., 2014).

Another study found a small but concerning error rate of as much as 0.05% in patient-note mismatches, where a clinical note pertaining to one patient was included in the electronic record of another patient (Wilcox et al., 2011).

Preventing Documentation Errors

Accurate documentation—written or electronic—is one of the most fundamental components in the medical record and is threaded through all quality indicators. For example, NQF has specific mentions of documentation as part of a number of its measures including:

  • 0045. Communication with the physician or other clinician managing on-going care post fracture for men and women aged 50 years and older
  • 0092. Emergency Medicine: Aspirin at Arrival for Acute Myocardial Infarction
  • 0419. Documentation of Current Medications in the Medical Record (NQF, n.d.-a)

There is a growing body of evidence of what errors can occur with electronic records, but there appears to be little research on a systems approach to preventing them as of yet.

What research there is calls for preventions to include application prompts, screens or warnings built into the system itself as well as barcode system for medications and supplies. Other studies recommend a variety of techniques including patient pictures; using a room number “watermark” on the electronic record display in busy emergency rooms to assist providers with patient identification; and even changes to the physical environment to make charting easier (Hyman et al., 2012; Yamamoto, 2014; Mahmood et al., 2009).



A 78-year-old man with hypertension and diabetes presented to an emergency department (ED) with new-onset chest pain. The ED physician reviewed the patient’s electronic medical record (EMR) and noted “PE” listed under past medical history, which raised his suspicion for the possibility of a new pulmonary embolus (PE). After initial testing excluded a cardiac etiology, a computed tomography (CT) scan of the chest was ordered to rule out a PE. When the physician approached the patient to explain why he was ordering the diagnostic test, the patient denied ever having a PE or being treated with blood thinners.

Puzzled by the conflicting reports, the ED physician returned to the EMR and noted that this mistaken history of PE dated back several years. It even appeared in the “problem list” section of his EMR. Investigating further back, the ED physician discovered that the letters “PE” were first noted nearly a decade earlier where it was clearly intended to reflect a “physical examination” rather than a “pulmonary embolus.” A physician likely copied and mistakenly pasted “PE” under “past medical history,” after which this history of pulmonary embolism was carried forward time and time again.

The patient, who was ultimately discharged from the ED, never suffered any harm from the documentation error. The EMR was updated to say “This patient never had a pulmonary embolism.”

Source: Hirschtick, 2012.

Factors Increasing the Risk of Medical Errors


Studying human performance can result in the creation of safer systems and the reduction of conditions that lead to errors.

Institute of Medicine, 1999
To Err is Human: Building a Safer Health System


There are many systemic factors that increase the likelihood of a medical error. Some of the most important factors are risky behaviors by healthcare workers, staffing issues, sleep deprivation, and environmental factors.

Risky Behaviors by Healthcare Workers

At-risk behaviors are actions by healthcare providers that compromise patient safety. Healthcare personnel may engage in risky behaviors because the rewards are immediate and the risk of patient harm seems remote. They may engage in risky behaviors when they become comfortable and competent with a task and lose the perception of risk. These behaviors often result in convenience, comfort, and saved time (NCCMERP, 2014a).

The perceived benefits of taking a risky shortcut leads to repeated at-risk behaviors, despite the healthcare provider’s possible knowledge, on some level, that patient safety could be at risk. In addition, as one healthcare worker has apparent success with an at-risk behavior, they will likely influence fellow workers until that behavior becomes a standard practice (NCCMERP, 2014a).

Risky behaviors often emerge because of systems-based problems in healthcare organizations. Common at-risk behaviors include:

  • Engaging in “grab and go” with a medication without fully reading the label before it is dispensed, administered or restocked
  • Intimidation or reluctance to ask for help or clarification
  • Failure to educate patients
  • Using medications without complete knowledge of the medication
  • Failure to double check high-alert medications before dispensing or administering
  • Not communicating important information such as patient allergies, diagnosis/co-morbid conditions, weight, and so on. (NCCMERP, 2014a)

When patient harm occurs, an organization often focuses on the “sharp end” of the medication-use process—the front-line healthcare workers involved in the event or engaged in the at-risk behavior. However, punishment based only on the outcome when other instances of at-risk behavior by an individual or group go unnoticed is often ineffective and can send the wrong signal to staff (NCCMERP, 2014a).

Risky behaviors can emerge because of systems-based problems within a healthcare organization, eg, an organizational culture with a high tolerance of such behaviors. Healthcare managers should review organizational behaviors regularly. Unnecessary complexity in processes provides many opportunities for health workers to take risks when providing care to a patient.

The National Coordinating Council on Medication Error Reporting and Prevention (NCCMERP) makes the following recommendations to reduce medication errors associated with at-risk behaviors:

  • Eliminate organizational tolerance of risk.
  • Determine systems-based reasons for risk-taking behavior.
  • Eliminate system-wide incentives for at-risk behaviors.
  • Motivate through feedback and rewards. (NCCMERP, 2014a)


Staffing is linked inseparably to patient safety. For several decades, healthcare researchers have reported an association between nurse staffing and the outcomes of hospital care. Nurses are experiencing higher workloads than ever before for several reasons: increased demand for nurses, inadequate supply of nurses, reduced staffing, increased overtime, and reduction in patient length of stay (Hughes & Blegen, 2008).

In addition, patients in hospitals today are sicker, requiring greater care. This in turn means there are fewer nurses available to mentor and monitor new nurses, which only exacerbates the problem (Kibbe, 2010).

Several reports show that a relationship exists between lower levels of nurse staffing and higher incidence of adverse patient outcomes. Nurses’ working conditions have been associated with medication errors, falls, spread of infection, and even increased deaths (Stone et al., 2004).

While nurse staffing levels have been associated with the spread of disease during outbreaks, increasing nurse-to-patient ratios alone is not adequate; more complex staffing issues appear to be at work. Many studies have found that the times of higher ratios of “pool staff” (nursing staff who were members of the hospital pool service or were agency nurses) to “regular staff” (nurses permanently assigned to the unit) were independently associated with healthcare-associated infections (Stone et al., 2004).

Results from a number of studies in the last decade in the United States and Canada showed that for every additional registered nurse (RN) full-time equivalent per patient day there was a relative risk reduction in hospital-related mortality of 9% in ICUs and 16% in surgical patients. Greater RN hours spent on direct patient care were associated with decreased risk of hospital-related death and shorter patient stays (AHRQ, 2013a).

The consequence of high nursing workload includes adverse effects on patient safety and decreased job satisfaction for nurses, which contributes to high turnover and an increased nursing shortage (Hughes & Blegen, 2008).

Sleep Deprivation

Studies have shown that failure to obtain adequate sleep is an important contributor to medical errors. In addition to jeopardizing patient safety, clinicians who fail to obtain adequate sleep are also risking their own health and safety. According to the National Center for Sleep Disorders Research, sleep loss is the leading cause of drowsy driving and sleep-related vehicle crashes. Drowsy drivers have slower reaction times, reduced vigilance, and information-processing deficits, which make it difficult to detect hazards and respond quickly and appropriately. Decreased sleep has also been linked to the increasing epidemic of obesity (Hughes & Blegen, 2008).

Individuals working night and rotating shifts rarely obtain optimal amounts of sleep. Night-shift workers have been shown to obtain 1 to 4 hours less sleep than the norm. Sleep loss is cumulative and by the end of the workweek the sleep loss may be significant enough to impair decision-making, initiative, integration of information, planning, and vigilance. A sleep-deprived individual may not recognize these effects until they are severe (Hughes & Blegen, 2008).

Studies have also shown that moderate levels of prolonged wakefulness can produce performance impairments equal to or greater than blood alcohol levels that are deemed unsafe for driving or operating heavy machinery. Despite reported nurse satisfaction with 12-hour shifts, recent studies have shown longer shifts and frequent overtime are associated with the difficulty of staying awake on duty, reduced sleep times, and nearly triple the risk of making an error (Hughes & Blegen, 2008).

Environmental Factors

The environment in which healthcare workers practice can also contribute to medical errors. Studies show that healthcare workers were:

  • Almost 3 times more likely to report a more hectic working environment in the 30 minutes before the error compared to the rest of the error shift
  • Nearly 2 times as likely to report a more hectic working environment when comparing the error shift to the prior shift
  • 4 times more likely to report a more hectic working environment when comparing the 30 minutes before the error to the prior shift worked (Grayson et al., 2005).

Not only can working conditions increase the chances for errors, the design of items in that environment can as well. For instance, AHRQ cited a study examining the design of the computerized physician order enter (CPOE) interface that required about 10 clicks per order, thus significantly increasing time needed to enter orders. The poor usability of the CPOE system and its lack of integration with clinician workflow contributed to delays in patient care that were a major factor in the increased mortality rate after CPOE implementation (AHRQ, 2013a).

Medication and product packaging can look similar to the item intended. A 2006 study detailed a situation where an epidural penicillin solution was given instead of an intravenous (IV) penicillin to a 16-year-old pregnant patient’s IV line, causing her immediate death. The IV and epidural bags had similar designs (AHRQ, 2013a).

The design of medical devices, even the drawers of medication carts, can affect medical errors—both negatively and positively. A redesigned drawer resulted in shorter medication retrieval time and fewer wasteful actions. The prototype drawer also received higher ratings for visibility, organization, and general usability (AHRQ, 2013a).

Vulnerable Populations


Children are at particular risk of medication errors . . . this is attributable primarily to incorrect dosages.

Institute of Medicine, 1999
To Err is Human: Building a Safer Health System


Anyone who takes medication has some risk of a harmful effect. There are some groups, however, that have an increased risk of adverse medication events. Children, the elderly, and those with limited English skills and/or poor health literacy are at a high risk for adverse events.


Take a look at the vitamins on the shelves at your local drug or grocery store. They come in an amazing array of colors, flavors, shapes, all looking—and tasting—very much like candy. Some pharmacies can even custom blend flavors such as chocolate, vanilla and bubble gum for children’s medications. Is it any wonder that finding and eating or drinking medicines on their own without adult supervision is the leading cause of emergency visits for adverse drug events incurred in the community among children less than 5 years old? An estimated 53,000 children less than 5 years old are brought to emergency departments each year because of unsupervised ingestions (CDC, 2010d).

Pediatric patients face four distinct issues that set them apart from the rest of the hospital population, making it a high-risk environment for hospitalized children:

  • Development. As children mature both mentally and physically, their needs for healthcare goods and services change.
  • Dependency. Hospitalized children are dependent on caregivers and parents to convey key information and their care must be approved by parents or their surrogates during all encounters.
  • Different epidemiology. Most hospitalized children require acute episodic care, not care for chronic conditions as with adults.
  • Demographics. Children are more likely to live in poverty and experience racial and ethnic disparities in healthcare, and they are more dependent on public insurance (Hughes & Blegen, 2008).

Medication errors are the most common adverse event experienced by pediatric inpatients. Often pediatric indications and dosage guidelines aren’t included with a medication, necessitating weight-based dosing or dilution, which, in turn creates more opportunity for error (PSNet, 2015; Hughes & Edgerton, 2005).

Preventing Medical Errors for Pediatric Inpatients

Children are not simply little adults; their physiology and mental development are vastly different from adults. While many of the same medical error prevention techniques for adults are perfectly acceptable for pediatric patients (eg, hand hygiene), others need more consideration.

In many settings, children are still weighed in pounds instead of kilograms. This can add another layer of complexity to calculating medication dosage, which is often based in kilograms. An AHRQ study recommended recording pediatric patients’ weight in kilograms to make calculating medication dosages easier (AHRQ, 2009).

In another study funded by AHRQ, researchers found increased error incidents in the pediatric ICU and recommended developing protocols for high-risk procedures, improved monitoring, staffing, training, and communication initiatives (AHRQ, 2013b).


Elderly patients are prescribed more than 30% of all prescription drugs. Adverse drug events or reactions to medicines are implicated in 5% to 17% of inpatient admissions (Alexander & Wang, 2014).

Elders in the Community

For many older adults in the community, the ability to remain independent in their homes depends on the ability to manage a complicated medication regimen. Non-adherence to medication regimens is a major cause of nursing home placement in older adults. In the United States, an estimated 3 million older adults are admitted to nursing homes due to drug-related problems at an annual cost of more than $14 billion (Hughes & Blegen, 2008).

As people age, they typically take more medicines. Older adults (>65 years) are twice as likely as others to come to emergency departments for adverse drug events (over 177,000 emergency visits each year) and nearly 7 times more likely to be hospitalized after an emergency visit (CDC, 2012b).

Most of these hospitalizations are due to a few drugs that require careful monitoring to prevent problems. These include blood thinners such as warfarin, diabetes medications like insulin, seizure medications such as phenytoin and carbamazepine, and heart medicine such as digoxin (CDC, 2012b).

Poor cognition is associated with inability to follow medication regimens. Forgetting is a major reason medication doses are missed. The most common type of noncompliance is dose omission, but over-consumption is also a mistake frequently made by older people (Hughes & Blegen, 2008).

Older adults have narrow therapeutic windows and require close monitoring, especially when on multiple medications. A review of emergency department visits of patients 65 years and older found that more than 10% of the visits were related to an adverse drug event and more than 30% had at least one potential adverse drug interaction in their medication regimen (Hughes & Blegen, 2008).

Poor vision and decreased manual dexterity are also problems for elders. It is common for medication bottle caps to be left off or not properly closed so the patient can access the medicine. One study showed that almost one-half of older patients stated that they were not able to read the labels on the bottles due to poor eyesight, inability to read English, or small writing on the bottles (Hughes & Blegen, 2008).

Another cause of non-adherence in elders is difficulty with medication procurement. In a study of elders at 15 days after hospitalization, 27% had not filled their new prescriptions (Hughes & Blegen, 2008).

Preventing Medical Errors for Elders in the Community

Medication reconciliation is the first step in helping older adults with medication management. Multiple studies have shown discrepancies as high as 66% in medications that were ordered and those actually being taken (Hughes & Blegen, 2008).

Pharmacy resources, such as medication reviews and computerized medication interactions programs, are effective tools to reduce adverse drug events in older patients. Patients who participate in pharmacy delivery programs and refill reminders have higher compliance than those who do not (Hughes & Blegen, 2008).

Hospitalized Elders

The older patient has increased risk for functional decline during hospitalization due to decreased mobility and other risks of hospitalization. They may also experience delirium due to a medical condition, leading to cognition issues in compliance with care. Beyond medication errors, frail elderly in the hospital have a higher risk for falls, hospital-acquired infections, and pressure ulcers (Hughes & Blegen, 2008).

Preventing Medical Errors for Hospitalized Elders

The elderly acute-care patient will benefit from the same medical error preventions as the rest of hospital population, but particular attention should be paid to falls, pressure ulcers, and hospital-acquired infections (Hughes & Blegen, 2008).

Those older than 65 with cognitive issues have the greatest risk for falls in the acute-care setting (Hughes & Blegen, 2008).Interventions for falls can include such protocols as frequent rounding and fall-risk assessment tools (see Medical Errors, Patient Falls section) (DuPree et al., 2014).

Elders are also among those at highest risk for pressure ulcers. Interventions for preventing pressure ulcers can include good skin hygiene and frequent position changes (see Medical Errors, Pressure Ulcers section) (MedLine Plus, 2014).

Patients with Limited Health Literacy

Health literacy is “the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions.” It includes the ability to understand instructions on prescription bottles, appointment slips, medical education brochures, doctors’ directions, and consent forms, and the ability to negotiate complex healthcare systems (NN/LM, 2013).

The burden of health literacy on those who have difficulty understanding English is enormous. Nearly 25 million people in the United States (8.6 %) are defined as limited English proficient, meaning that they speak English less than “very well.” Therefore, at least 8.6 % of the U.S. population is at risk for adverse events because of barriers associated with their language ability (Betancourt et al., 2012).

In fact, a 2010 study examined the claims of a single malpractice carrier that insures in four states and found that 35 medical malpractice claims resulted in $2,289,000 in damages or settlements and $2,793,800 in legal fees largely due to communication issues. In one particular case cited, a 9-year-old child, who was the patient, acted as interpreter for the family (Quan, 2010).

Communication problems are the most frequent root cause of serious adverse events reported to the Joint Commission’s Sentinel Event Database (Betancourt et al., 2012).

The Joint Commission notes that “health literacy issues and ineffective communications place patients at greater risk of preventable adverse events.” Studies have shown that lower health literacy is linked to a lower likelihood of getting flu shots and of understanding medical labels and instructions, and a greater likelihood of taking medicines incorrectly. It is also linked with poorer health status, less use of preventive care, more likelihood of hospitalization, and bad disease outcomes. The annual cost to the U.S. economy of low health literacy is estimated to be between $106 billion and $238 billion (NN/LM, 2013).

Populations most vulnerable to poor health literacy include:

  • Older adults. Adults over 65 use more medical services and acquire more chronic illnesses than other population groups, yet 71% have difficulty using printed materials, 80% have difficulty using forms and charts, and 68% have difficulty interpreting numbers and making calculations, and it is estimated that two-thirds do not understand the information regarding their prescription medications.
  • Minority populations. The number of adults at the “Below Basic” level is higher among Hispanics (41%), American Indian/Native Alaskans (25%), Blacks (24%), and Asians (13%) than among whites (9%).
  • Low income. Adults living below the poverty level have a lower average health literacy than those living above the poverty level (NN/LM, 2013).

Preventing Medical Errors in Those with Limited Health Literacy

The AHRQ recommends a number of actions to mitigate the issues of medical errors among those with limited health literacy:

  1. Develop dedicated services for interpretation that include qualified medical interpreters, in person or by telephone.
  2. Provide patients with written materials, such as informed consent forms or procedure instructions, in their preferred written language.
  3. Identify patient’s language needs on boards on the inpatient floors that list current patients and responsibilities.
  4. Create a mechanism to schedule an interpreter automatically at clinical points of service for limited English proficiency patients.
  5. Develop visual cues to remind hospital staff to attend to language and cultural needs.
  6. Train staff on team communication, interpreter use, cultural competency, and advocacy.
  7. Consider other initiatives to improve safety for those with limited English proficiency and culturally diverse patients (Betancourt et al., 2012).

Reducing Errors and Increasing Patient Safety


Health care organizations must develop a culture of safety such that an organization’s care processes and workforce are focused on improving the reliability and safety of care for patients.

Institute of Medicine, 1999
To Err is Human: Building a Safer Health System


Governments, healthcare personnel, patients, and the public must work together to create a culture of safety, decrease the effects of medical errors, and improve the safety of healthcare. Each has a role to play.

Creating a Culture of Safety

For decades, the healthcare industry, along with a myriad of agencies and stakeholders, has sought a way to curb medical errors. This has resulted in a major shift in philosophy from one of blame to one of changing cultures across the continuum of care.

Garrouste-Orgeas and colleagues (2012) wrote,

Errors are caused by combinations of human factors and system factors, and information must be obtained on how people make errors. . . . Preventive strategies are more likely to be effective if they rely on a systems-based approach, in which organizational flaws are remedied, rather than a human-based approach of encouraging people not to make errors. The development of a safety culture . . . is crucial to effective prevention and should occur before the evaluation of safety programs, which are more likely to be effective when they involve bundles of measures.

While the researchers were speaking in terms of the intensive care unit, the lessons can be applied to many care settings (Garrouste-Orgeas et al., 2012).

Garrouste-Orgeas and colleagues (2012) suggested that

. . . a safety culture arises from a combination of a room-for-improvement model, in which problems are identified, plans are made to resolve them, and the results of the plans are measured; and the monitoring model, in which quality indicators are defined as relevant to potential problems and then monitored periodically. Indicators that reflect structures, processes, or outcomes have been developed by medical societies. Surveillance of these indicators is organized at the hospital or national level. Using a combination of methods improves the results.

Creating a “Just” Culture

Many agencies have adopted some version of the culture of safety, with varying degrees of success. In 2012 the National Association for Healthcare Quality (NAHQ) issued Call to Action: Safeguarding the Integrity of Healthcare Quality and Safety Systems, a document based on wide-ranging research about the efficacy of the culture of safety. Its executive summary, used here by permission, reads in part:

. . . [I]t is widely recognized that there is more work needed to eliminate preventable harm in the U.S. healthcare system. While a strong and just safety culture has been recognized as a key element for improvement, a critical deficit that has not yet been fully addressed is the lack of protective infrastructure to safeguard responsible, accurate reporting of quality and patient safety outcomes and concerns. . . .

Some healthcare providers acknowledge that they fear reporting events or conditions that could endanger quality and patient safety. Some professionals whose direct responsibilities include the monitoring and reporting of quality and patient safety outcomes have experienced pressure, outright harassment, or [have] even experienced serious legal and licensure challenges when they recognize and report events of concern. . . .

The accelerating implementation of new financial models that tie quality outcomes to payment will raise the stakes associated with quality results. The need will be even greater for a protective infrastructure to safeguard accurate reporting of quality data and patient safety concerns.

[These goals] are widely endorsed by leading healthcare and patient advocacy groups: meaningful and measurable improvement in patient outcomes, safety, and quality of care; improvement in the patient experience; and transparency of quality and safety data. These goals can be attained only with impeccable accuracy and trustworthy reporting. In any given situation where quality or patient safety is called into question, the process by which an issue is reported is as important as the query itself. Not every question of concern about patient safety or quality of patient care will ultimately be deemed valid; but every reported concern deserves consideration. A culture that encourages such disclosures is critical to improved patient care. So is the process by which concerns are examined, investigated, and ultimately determined to be valid or not (NAHQ, 2012).


Framework for Action: Integrity in Healthcare Quality and Safety

image: framework for action: integrity in healthcare quality and safety

Source: NAHQ, 2012. Used by permission.


Implementing Electronic Health Records (EHR)

The report that served as the clarion for efforts to prevent medical errors—IOM’s “To Err is Human”—noted that electronic systems are an “effective remedy” to combat them (IOM, 1999). The use of electronic health records (EHRs) has grown since the IOM report, bolstered by several game-changing pieces of legislation.

HIPAA, 1996

The central theme of the Health Insurance Portability and Accountability Act (HIPAA) was to protect healthcare coverage and privacy for workers and their families as they changed jobs, it also called for the development of health information systems and standards for electronic data interchange, the methodology whereby patient information is transmitted electronically (GPO, 1996).

HITECH Act, 2009

Enacted as part of the American Recovery and Reinvestment Act of 2009, it was called the Health Information Technology for Economic and Clinical Health Act (HITECH), and it authorized Medicare and Medicaid to provide incentive payments for eligible professionals, hospitals, and critical access hospitals as they adopt, implement, upgrade, or demonstrate “meaningful use” of EHR technology. Meaningful use is defined as using certified electronic health record (EHR) technology to improve quality, safety, efficiency, and reduce health disparities; engage patients and family; improve care coordination, and population and public health; and maintain privacy and security of patient health to improve patient care (HHS, 2009; ONC, 2015; ONC, 2015a).

Affordable Care Act (ACA), 2010

Perhaps the most broad-reaching piece of healthcare legislation in American history is the Patient Protection and Affordable Care Act of 2010 (ACA). As part of the legislation’s timed roll-out, ACA mandated technologic reforms in 2012 in the use of electronic health records to improve efficiencies (HHS, 2015).

Reducing Medication Errors

Medication errors are the most common of all medical errors, thus requiring additional focus. Even simple medication mistakes can have horrific results. Fortunately, relatively simple approaches can prevent many errors.

Adverse drug reactions can be detected and prevented through systems intervention. Tools such as computerized physician orders and prescription entry (CPOE) and bar coding systems have taken the guess work out of reading written prescriptions for nurses and pharmacists. Medication errors can be reduced potentially through the use of EHRs as well as drug-interaction screening software that detects and alerts the physician and pharmacist to potentially serious drug interactions.

The HITECH Act’s meaningful use policy has specific medication management measures:

  • Using CPOE systems for medication orders
  • Implementing decision support systems to check for drug–drug and drug–allergy interactions
  • Having the capability to electronically exchange key clinical information (such as medication lists, medication allergies, and test results) with other providers
  • Maintaining an active medication list, and
  • Maintaining an active medication allergy list (Murphy & White, 2014)

Closer to home, a study funded by AHRQ found Florida hospitals that adopted all five core measures of meaningful use for medication management in 2010 had the lowest rate of adverse drug events of all hospitals in the state. Intriguingly, hospitals where physicians objected to adopting HITECH’s meaningful use measures for medication management saw their adverse drug events increase by 14%, compared to a 52% reduction at hospitals where physicians supported the medication management meaningful use measures (Murphy & White, 2014).

The AVOID Mnemonic

Clinicians cannot rely solely on technology to prevent errors in prescribing and administering of medications. Frequent consultation with other members of the healthcare team is just as invaluable.

Use of an organized, step-wise approach also helps prevent drug interactions. The AVOID mistakes mnemonic can be used to collect all necessary information for the medication history (see table below).


Source: FDA, 2014.

AVOID Mnemonic


What to ask


Ask the patient if there is any drug that should not be prescribed for any reason.

Vitamins or herbs

Ask the patient whether the patient is taking or has a reaction to any herb, vitamin, or “alternative” or “natural” product.

Old drugs and over the counter (OTC) drugs…in addition to all current drugs

Ask about old drugs (prescription and OTC) as well as current drugs the patient is taking. Some of these drugs may have relatively long-lasting effects (either toxicity or potential for drug interactions).


Evaluate the potential for adverse drug interactions. Consider a behavioral contract between the physician and the patient in an effort to help the patient reach the therapeutic goal, either in the case of drug dependence or adherence to a therapeutic regimen, with a clear plan.

Dependence potential

Is the patient drug dependent or at risk of dependence on, for example, opioids, benzodiazepines, alcohol, or other substances of abuse. Consider a behavioral contract between the physician and the patient in an effort to help the patient reach the therapeutic goal, both in the case of drug dependence and in adherence to a therapeutic regimen.

Mendel (genetics)

Genetics: Is there a family history of benefits from or problems with any drugs?


Six Rights of Medication Administration

When dispensing medications, a systematic approach such as the (DHHS) Six Rights of Medication Administration encourages providers to pause and verify that the medications they are about to give are safe and accurate.

When giving medications, regardless of the type, the following six rights must be followed:

  1. Right individual
  2. Right medication
  3. Right dose
  4. Right time
  5. Right route
  6. Right documentation (NH HHS, 2011)

Reporting an Adverse Drug Event

MedWatch, the FDA Medical Products Reporting Program, was established in 1993 to emphasize the responsibility of providers to identify and report adverse events that may be related to FDA-regulated products (FDA, 2013).

The MedWatch program has three goals:

  • Educate both healthcare providers and patients about the importance of reporting serious adverse events, product quality problems, product use errors, and therapeutic failure or lack of equivalence.
  • Facilitate and support this reporting.
  • Maintain and expand Web-based tools and processes for disseminating the resulting new safety information, ideally delivered to the point of care, for use by providers and their patients in a shared decision-making process. (FDA, 2013)

There are three ways to report an adverse event to MedWatch:

  • Complete the voluntary Form FDA 3500 online
  • Call 800 FDA 1088 to report by telephone.
  • Download a reporting form (Form FDA 3500 or 3500B (a new, consumer-oriented form) and either fax it to 800 FDA 0178 or mail it (For both forms, click this link) (FDA, 2013).

10 Patient Safety Tips for Hospitals (AHRQ)

Medical errors may occur in different healthcare settings, and those that happen in hospitals can have serious consequences. AHRQ, which has sponsored hundreds of patient safety research and implementation projects, offers these 10 evidence-based tips to prevent adverse events from occurring in hospitals:

  1. Prevent central line-associated bloodstream infections.
  2. Re-engineer hospital discharges.
  3. Prevent venous thromboembolism.
  4. Educate patients about using blood thinners safely.
  5. Limit shift durations for medical residents and other hospital staff if possible.
  6. Consider working with a Patient Safety Organization (PSO).
  7. Use good hospital design principles.
  8. Measure your hospital’s patient safety culture.
  9. Build better teams and rapid response systems.
  10. Insert chest tubes safely. (AHRQ, 2009a)


Video: Fostering a Culture of Safety (4:03)

This video vignette shows a fictional scenario in which a positive culture of safety overcomes multiple commonly seen barriers to infection prevention in dialysis facilities (AHRQ, 2014).


Public Awareness and Education


Although the risk of dying as a result of a medical error far surpasses the risk of dying in an airline accident, a good deal more public attention has been focused on improving safety in the airline industry than in the health care industry.

Institute of Medicine, 1999
To Err is Human: Building a Safer Health System


As health insurers have moved toward shifting more healthcare costs to the patient, the public has never been more aware of their role of taking charge of their own care. For example, as of 2014 the final amendments to CLIA give patients the right to receive a copy of their laboratory test reports if requested without waiting for a release from a caregiver (Federal Register, 2014).

Public Awareness of Safety

Patients have greater access to health information than ever before to make sound decisions. Consequently, patients and their families also have a role to play in improvement healthcare quality and safety by being a partner with providers.

AHRQ’s Guide to Patient and Family Engagement in Hospital Quality and Safety (2013c) provides a detailed framework of how hospitals and patients can work together to make care safer. The comprehensive guide makes a number of recommendations, including:

  • Invite two or three patient and family advisors to a hospital staff or committee meeting to discuss their hospital stay. Advisors can share what went well, what could have been done better, and any ideas they have for changes and improvements.
  • At each shift change, shift report happens at the patient’s bedside, and the nurses invite the patient and family or friends to take part in the report.
  • Include the patient and family as full partners in the discharge planning process, reviewing medications, highlighting warning signs and problems, and suggesting what life will be like at home (AHRQ, 2013c).

Public Education on Medical Errors

AHRQ has also developed a list of 20 tips patients can follow to prevent medical errors. Research shows that patients who are more involved with their care tend to get better results.

20 Tips to Help Prevent Medical Errors (AHRQ)


  1. Make sure that all of your doctors* know about every medicine you are taking. This includes prescription and over-the-counter medicines and dietary supplements, such as vitamins and herbs.
  2. Bring all of your medicines and supplements to your doctor visits. “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 and help you get better quality care.
  3. Make sure your doctor knows about any allergies and adverse reactions you have had to medicines. This can help you to avoid getting a medicine that could harm you.
  4. When your doctor writes a prescription for you, make sure you can read it. If you cannot read your doctor’s handwriting, your pharmacist might not be able to either.
  5. Ask for information about your medicines in terms you can understand—both when your medicines are prescribed and when you get 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?
  6. When you pick up your medicine from the pharmacy, ask: Is this the medicine that my doctor prescribed?
  7. 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 times daily” means taking a dose every 6 hours around the clock or just during regular waking hours.
  8. Ask your pharmacist for the best device to measure your liquid medicine. For example, many people use household teaspoons, which often do not hold a true teaspoon of liquid. Special devices, like marked syringes, help people measure the right dose.
  9. 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.

Hospital stays

  1. If you are in a hospital, consider asking all health care workers who will touch you whether they have washed their hands. Handwashing can prevent the spread of infections in hospitals.
  2. When you are being discharged from the hospital, ask your doctor to explain the treatment plan you will follow at home. This includes learning about your new medicines, making sure you know when to schedule followup appointments, and finding out when you can get back to your regular activities. It is important to know whether or not you should keep taking the medicines you were taking before your hospital stay. Getting clear instructions may help prevent an unexpected return trip to the hospital. 


  1. If you are having surgery, make sure that you, your doctor, and your surgeon all agree on exactly what will be done. Having 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 percent preventable. Surgeons are expected to sign their initials directly on the site to be operated on before the surgery.
  2. If you have a choice, choose a hospital where many patients have had the procedure or surgery you need. Research shows that patients tend to have better results when they are treated in hospitals that have a great deal of experience with their condition.

Other steps

  1. Speak up if you have questions or concerns. You have a right to question anyone who is involved with your care.
  2. Make sure that someone, such as your primary care doctor, coordinates your care. This is especially important if you have many health problems or are in the hospital.
  3. Make sure that all your doctors have your important health information. Do not assume that everyone has all the information they need.
  4. Ask a family member or friend to go to appointments with you. Even if you do not need help now, you might need it later.
  5. 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.
  6. If you have a test, do not assume that no news is good news. Ask how and when you will get the results.
  7. Learn about your condition and treatments by asking your doctor and nurse and by using other reliable sources. For example, treatment options based on the latest scientific evidence are available from the Effective Health Care website. Ask your doctor if your treatment is based on the latest evidence.

*The term “doctor” is used to refer to the person who helps you manage your healthcare.
Source: AHRQ, 2015d.

Systems Approaches to Reducing Medical Errors


Safety does not reside in a person, device or department, but emerges from the interactions of components of a system.

Institute of Medicine, 1999
To Err is Human: Building a Safer Health System


Modern systems approaches to reduce errors and improve efficiency have their roots in the manufacturing quality and process control principles developed by renown statistician W. Edwards Deming, engineers Joseph M. Juran and Kaoru Ishikawa, and former Secretary of Commerce and quality management champion Malcolm Baldrige, among others.

When a manufacturing process is standardized, it often leads to greater efficiency and fewer mistakes. It’s no wonder than some of these same processes (systems) for finding, analyzing, and preventing manufacturing errors are being applied to healthcare.

An important contributor to medical errors is lack of communication between co-workers, departments, shifts, even among different organizations and levels of care. Many doctors, nurses, and other healthcare professionals see a particular patient for different aspects of the patient’s care. This makes creating a culture of safety a huge organizational challenge, one that needs to be evaluated constantly and systematically. According to the IOM, most medical errors are the result of systems failures that require analysis on a systems level to understand their cause and to promote corrective action.

Indeed, Garrouste-Orgeas and colleagues (2012) wrote,

Preventive strategies are more likely to be effective if they rely on a system-based approach, in which organizational flaws are remedied, rather than a human-based approach of encouraging people not to make errors.

Root Cause Analysis

Root cause analysis (RCA) is a systems approach that asks three questions that provide the framework for information collection?

  1. What is the problem?
  2. Why did it happen?
  3. What can be done to prevent it from occurring again?

According to the book Internal Bleeding, “RCA attempts to write a second story about the actions that led to error—to look past the obvious. . . scapegoats and find the other culprits, however deeply they may be embedded in the system.” (Wachter & Shojania, 2004).

In 1997 the Joint Commission (then called the Joint Commission on the Accreditation of Healthcare Organizations, or JCAHO) mandated the use of root cause analysis in the investigation of sentinel events or medical errors in accredited hospitals. There are two main categories of error:

  1. Active error, which usually occurs when humans interact with a complex system
  2. Latent error, which represents failures of system design (Hughes & Blegen, 2008)

Root cause analysis is used to identify trends and assess risk when human error is suspected, with the understanding that systemic factors, rather than individual factors, are likely the root cause of the problem. The goal is to avoid a culture of blame. Systematic application of RCA can uncover root causes that link varied accidents such as a variety of serious adverse events occurring at shift change. Careful analysis may suggest system changes designed to prevent future incidents (Hughes & Blegen, 2008).

When a sentinel event has been identified for analysis, a multidisciplinary team is assembled to direct the investigation. The team members must be trained in the techniques of RCA because the tendency to revert to personal bias is strong. Multiple investigators allow for comparison and corroboration of major findings and increase the validity of final results (Hughes & Blegen, 2008).

Accident analysis is generally broken down into the following steps:

  • Data collection, which establishes what happened through interviews, document review, or field observation. These data are then used to make a timeline of events before and after the accident.
  • Data analysis, which is a process that examines the sequence of events and determines common underlying factors. During this phase of RCA, investigators establish how the event happened by identifying failures in the sequence and determining why the event occurred.

At the conclusion of the RCA, the team summarizes the underlying causes and their relative contributions, and begins to identify administrative and systems problems that might be candidates for redesign (Hughes & Blegen, 2008). 

Plan-Do-Study-Act Cycle

Another systems approach to eliminating medical errors is called Plan-Do-Study-Act approach (PDSA), devised by the Institute for Healthcare Improvement. This strategy has been widely used by the Institute and many other healthcare organizations. One of the unique features of this strategy is the acknowledgement that change is cyclical in nature and benefits from small and frequent PDSAs rather than big and slow ones, before changes are made system-wide (IHI, 2011).

The PDSA cycle tests a change by “developing a plan to test the change (Plan), then carrying out the test (Do), observing and learning from the consequences (Study), and determining what modifications should be made to the test (Act)” (IHI, 2011).

The TeamSTEPPS Approach

Another systems approach to the problem of medical errors is the Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) approach. A key point is that, even though the delivery of care requires teamwork, members of these teams are rarely trained together and they often come from separate disciplines and diverse educational programs (King et al., 2008).

Given the interdisciplinary nature of healthcare and the necessity for cooperation among those who perform it, teamwork is critical to ensure patient safety. Teams make fewer mistakes than individuals, especially when each team member knows his or her responsibilities. Simply conducting training or installing a team structure does not ensure that the team will operate effectively (King, et al., 2008).

There are three phases to the TeamSTEPPS approach:

  • Phase I involves assessment and setting the stage.
  • Phase II includes planning, training, and implementation.
  • Phase III sustains and spread improvements in teamwork performance, clinical processes, and outcomes. (King, et al., 2008)

Lean Six Sigma for Healthcare

Lean Six Sigma is the combination of two methodologies, Lean and Six Sigma. Lean attempts to eliminate waste within a process, and Six Sigma (named for six standard deviations from the mean — three above and three below) attempts to reduce variation and defects (AHRQ HIT, 2008).

Central to Lean Six Sigma is the Define, Measure, Analyze, Improve, and Control (DMAIC) lifecycle (see below).


Lean Six and the DMAIC Lifecycle

image: chart of DMAIC Process

Source: Meliones, Alton, & Mericle, et al., 2008.


Lean Six Sigma is the gold standard manufacturing system for many Fortune 500 companies; however, it is a large, complicated process requiring extensive training to implement.

Nevertheless, Lean Six Sigma can be used to decrease medical errors and improve outcomes. In one example, North Mississippi Medical Center reduced the number of prescription instruction errors in discharge documents by 50% using Lean Six Sigma, according to American Society for Quality (ASQ, n.d.). In fact, Six Sigma programs incorporating some Lean principles were shown to have positive results on:

  • Surgery turnaround time
  • Clinic appointment access
  • Hand hygiene compliance
  • Antibiotic prophylaxis in surgery
  • Scheduling radiology procedures
  • Catheter-associated bloodstream infections
  • Meeting CMS cardiac indictors
  • Hospital-acquired urinary tract infections
  • Operating room throughput
  • Coagulation testing in the laboratory
  • Handoff communications with high-risk patients (Vest & Gamm, 2009; Hurley et al., 2008)


Video: IHI Open School: Whiteboard—The PDSA Cycle, Part I (4:46)
Published March 28, 2012



To err is human, but errors can be prevented..

Institute of Medicine, 1999
To Err is Human: Building a Safer Health System


As healthcare has become more complex, it has increased the probability that medical errors will occur. According to the landmark 1999 Institute of Medicine (IOM) report, “To Err Is Human,” medical errors are a common occurrence, and some 98,000 deaths each year in the United States are due to human error in the delivery of healthcare. Recent studies, however, suggest that number is much higher—400,000 or more.

Prior to the IOM report, it was recognized that medical errors occurred, but the focus was on ridding the healthcare system of the incompetent care providers who were committing these errors. It was thought that errors could be prevented by simply investigating the events and individuals who cause harm to patients. Few of these investigations, however, focused on the cluster of events that came together in an unfortunate sequence to allow an error to occur.

Since 1999 the focus of medical error prevention has been on systems and how they create an environment that allows these errors to occur. Quality, we have come to learn, can be defined, measured, and improved to provide safer care.

Resources and References


Florida Agency for Health Care Administration (AHCA)

Office of Risk Management & Patient Safety

Institute for Safe Medicine Practices (ISMP)

A non-profit organization devoted entirely to medication errors and safe medication use. The Institute “collects and analyzes reports of medication hazardous conditions, near-misses, errors, and other adverse events.” ISMP also “disseminates timely medication safety information, risk reduction tools, and error-prevention strategies.”


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