Patient Safety and Quality of Care





In late January 2001, 18-month-old Josie King turned on the hot water and climbed into a scalding-hot bathtub. She sustained second-degree burns on 60% of her body and was admitted to Johns Hopkins Medical Center. On February 22, 2001, 2 days before her planned discharge home, Josie’s parents held their brain-dead daughter for the last time as she was disconnected from the ventilator. Her death was the result of severe dehydration and a narcotic overdose—a series of medical errors that occurred in one of the best medical centers in the country.




Quality Care Movement in America


In 2000, the Institute of Medicine (IOM) Committee on the Quality of Health Care in America published a landmark report entitled To Err Is Human, Building a Safer Health System . The report cited a study that estimated 98,000 people died every year in U.S. hospitals as a result of medical errors. This is analogous to crashing a jumbo jet every day for a year and killing all the passengers on board. The analogy provided a stirring, concrete image for the magnitude of the death toll. Until this report, the magnitude of the medical error problem in the U.S. health care system was largely unrecognized.


A study published in 2013 reported the number of preventable deaths caused by medical errors to be significantly higher—an estimated 400,000 deaths annually. If the Centers for Disease Control and Prevention (CDC) ranked medical errors as a cause of death in the United States, it would rank third behind heart disease and cancer. Furthermore, medical errors that result in patient harm but not death are estimated between 4 million and 8 million annually.


In addition to the cost in human lives, preventable medical errors have been estimated to result in total costs (additional care, lost income, lost productivity, and disability) as high as $29 billion annually. That number is estimated to reach $1 trillion annually when quality-adjusted life years are considered for those who die. The less quantifiable toll of physical and psychological pain, reduced patient and provider satisfaction and trust, and poorer health status of communities and society is a significant outcome of medical errors as well.


Since the initial report was published in 2000, many public and private institutions have become involved in efforts to raise awareness of the problem and create tools for providers to use to detect and address medical errors in a systematic fashion.


Determining the Magnitude of the Problem


In 2002, the Agency for Healthcare Research and Quality (AHRQ), in collaboration with the University of California–Stanford Evidence-Based Practice Center, developed a collection of patient safety indicators (PSIs) to help health care organizations and hospitals assess, track, monitor, and improve patient safety. These PSIs can be readily identified in hospital discharge data and are deemed potentially preventable patient safety incidents. In 2003, this set of 20 evidence-based PSIs was released to the public. As of 2016, the list has been expanded to include 25 PSIs ( Box 39.1 ). These indicators are commonly used by health care organizations and governmental agencies to determine the magnitude of the problem.



BOX 39.1

Agency for Healthcare Research Patient Safety Indicators

From Agency for Healthcare Research and Quality. AHRQ Quality Indicators: Patient Safety Indicators , September 2015. www.qualityindicators.ahrq.gov/Downloads/Modules/PSI/V50/PSI_Brochure.pdf .





  • PSI 02 Death Rate in Low-Mortality Diagnosis Related Groups (DRGs)



  • PSI 03 Pressure Ulcer Rate



  • PSI 04 Death Rate among Surgical Inpatients with Serious Treatable Conditions



  • PSI 05 Retained Surgical Item or Unretrieved Device Fragment Count



  • PSI 06 Iatrogenic Pneumothorax Rate



  • PSI 07 Central Venous Catheter-Related Blood Stream Infection Rate



  • PSI 08 Postoperative Hip Fracture Rate



  • PSI 09 Perioperative Hemorrhage or Hematoma Rate



  • PSI 10 Postoperative Physiologic and Metabolic Derangement Rate



  • PSI 11 Postoperative Respiratory Failure Rate



  • PSI 12 Perioperative Pulmonary Embolism or Deep Vein Thrombosis Rate



  • PSI 13 Postoperative Sepsis Rate



  • PSI 14 Postoperative Wound Dehiscence Rate



  • PSI 15 Accidental Puncture or Laceration Rate



  • PSI 16 Transfusion Reaction Count



  • PSI 17 Birth Trauma Rate – Injury to Neonate



  • PSI 18 Obstetric Trauma Rate – Vaginal Delivery With Instrument



  • PSI 19 Obstetric Trauma Rate – Vaginal Delivery Without Instrument



  • PSI 21 Retained Surgical Item or Unretrieved Device Fragment Rate



  • PSI 22 Iatrogenic Pneumothorax Rate



  • PSI 23 Central Venous Catheter-Related Blood Stream Infection Rate



  • PSI 24 Postoperative Wound Dehiscence Rate



  • PSI 25 Accidental Puncture or Laceration Rate



  • PSI 26 Transfusion Reaction Rate



  • PSI 27 Postoperative Hemorrhage or Hematoma Rate



  • PSI 90 Patient Safety for Selected Indicators




Why Errors Occur


Historically, medical errors have been hidden from the public. The IOM reports that “The biggest challenge to moving toward a safer health system is changing the culture from one of blaming individuals for errors to one in which errors are treated not as personal failures, but as opportunities to improve.” The modern patient safety movement has replaced the secrecy and “blame and shame” of medical errors with a systems approach used in other high-risk industries such as airlines and nuclear power plants. This paradigm acknowledges humans as fallible and seeks to create strategies to anticipate, prevent, or catch unsafe events before they cause harm. The systems approach for safety in other industries has well-known and proven strategies, but these approaches have not been applied to medicine until recently.


The Swiss cheese model of organizational accidents developed by British psychologist James Reason is a good way to illustrate how medical errors occur ( Fig. 39.1 ). Rather than errors being the result of a single incident, they are viewed as multiple layers of fail-safes in which the holes align to produce a medical error. For example, there are several layers of protection for a patient whose provider orders the wrong dosage of a home medication in the hospital. First, the order must be received by the pharmacist and not recognized as an error. Next, the nurse administering the medication must also fail to recognize the dosage error. Finally, the patient would need to accept the error as well. The model seeks ways to shrink the holes in each layer of protection, thus making the alignment less likely and resulting error less likely to occur. It also emphasizes the need to identify the root causes that make the medical errors possible.




FIG. 39.1


Swiss cheese model of medical errors.

(From Reason J. Human error: models and management. BMJ 2000;320:768. www.bmj.com.easyaccess1.lib.cuhk.edu.hk/content/320/7237/768.full .)


Human Mistakes


The overwhelming majority of medical mistakes are not made because of a lack of knowledge, training, or information but rather result from faulty systems and poorly designed processes. When human errors do occur, they are made by honest, hard-working individuals who have demanding and often stressful jobs. They often occur during automatic tasks when unintentional performance lapses in an environment where faulty processes, systems, or conditions fail to catch or prevent the error. The medical profession is often compared with other high-risk occupations whose members must perform under a high degree of stress with a high degree of accuracy. The difference is that medical professionals must combine complex decision making with customer interactions and automatic behaviors. The training for medical providers has emphasized decision making with significantly less of a focus on customer interaction and essentially no training in how to manage risky automatic behaviors.




Types of Medical Errors


In 2001, the former chief executive officer of the National Quality Forum (NQF) coined the term “never event” to identify especially egregious medical errors (such as wrong-site surgery) that should never occur. Since that time, the list of never events has been expanded to include 29 events grouped into six categories: surgical, product or device, patient protection, care management, environmental, and criminal ( Box 39.2 ). More than 4000 surgical never events occur in the United States every year and have resulted in malpractice payments totaling more than $1.3 billion over the past 20 years. Relative to the number of medical errors, never events occur infrequently. When they do occur, however, they are very likely to be fatal. Over the past 12 years, 71% of never events resulted in death.



BOX 39.2

National Quality Forum’s Health Care “Never Events,” 2011 Revision

From Agency for Healthcare Research and Quality. Never Events . psnet.ahrq.gov/primers/primer/3/never-events .


Surgical Events





  • Surgery or other invasive procedure performed on the wrong body part



  • Surgery or other invasive procedure performed on the wrong patient



  • Wrong surgical or other invasive procedure performed on a patient



  • Unintended retention of a foreign object in a patient after surgery or other procedure



  • Intraoperative or immediately postoperative or postprocedure death in an American Society of Anesthesiologists class I patient



Product or Device Events





  • Patient death or serious injury associated with the use of contaminated drugs, devices, or biologics provided by the health care setting



  • Patient death or serious injury associated with the use or function of a device in patient care in which the device is used for functions other than as intended



  • Patient death or serious injury associated with intravascular air embolism that occurs while being cared for in a health care setting



Patient Protection Events





  • Discharge or release of a patient or resident of any age who is unable to make decisions to other than an authorized person



  • Patient death or serious disability associated with patient elopement (disappearance)



  • Patient suicide, attempted suicide, or self-harm resulting in serious disability while being cared for in a health care facility



Care Management Events





  • Patient death or serious injury associated with a medication error (e.g., errors involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation, or wrong route of administration)



  • Patient death or serious injury associated with unsafe administration of blood products



  • Maternal death or serious injury associated with labor or delivery in a low-risk pregnancy while being cared for in a health care setting



  • Death or serious injury of a neonate associated with labor or delivery in a low-risk pregnancy



  • Artificial insemination with the wrong donor sperm or wrong egg



  • Patient death or serious injury associated with a fall while being cared for in a health care setting



  • Any stage 3, stage 4, or unstageable pressure ulcers acquired after admission or presentation to a health care facility



  • Patient death or serious disability resulting from the irretrievable loss of an irreplaceable biological specimen



  • Patient death or serious injury resulting from failure to follow up or communicate laboratory, pathology, or radiology test results



Environmental Events





  • Patient or staff death or serious disability associated with an electric shock in the course of a patient care process in a health care setting



  • Any incident in which a line designated for oxygen or other gas to be delivered to a patient contains no gas, the wrong gas, or is contaminated by toxic substances



  • Patient or staff death or serious injury associated with a burn incurred from any source in the course of a patient care process in a health care setting



  • Patient death or serious injury associated with the use of restraints or bedrails while being cared for in a health care setting



Radiologic Events





  • Death or serious injury of a patient or staff associated with introduction of a metallic object into the MRI area



Criminal Events





  • Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed health care provider



  • Abduction of a patient or resident of any age



  • Sexual abuse or assault on a patient within or on the grounds of a health care setting



  • Death or significant injury of a patient or staff member resulting from a physical assault (i.e., battery) that occurs within or on the grounds of a health care setting



ABO/HLA, blood group consisting of groups A, AB, B, and O/human leukocyte antigen


MRI, Magnetic resonance imaging.



The Joint Commission has also compiled a list of events that signal the need for immediate investigation. These so-called sentinel events (that include the above never events) are defined by The Joint Commission as “unexpected occurrence[s] involving death or serious physical or psychological injury, or the risk thereof.” Serious injury is further defined as including the “loss of limb or function,” and the phrase “or the risk thereof” includes any actions or events that would increase the risk of a serious adverse outcome if it occurred again. The Joint Commission’s list of sentinel events is shown in Box 39.3 .



BOX 39.3

Joint Commission Sentinel Events, 2012 Updates

From The Joint Commission. Sentinel Events (SE). www.jointcommission.org/assets/1/6/camh_2012_update2_24_se.pdf .




  • 1.

    Any event that has resulted in an unanticipated death or major permanent loss of function not related to the natural course of the patient’s illness or underlying condition or


  • 2.

    Any event that is one of the following (even if the outcome was not death or major permanent loss of function not related to the natural course of the patient’s illness or underlying condition):




    • Infant discharge to the wrong family



    • Unexpected death of a full-term infant



    • Abduction of any patient receiving care, treatment, and services



    • Invasive procedure, including surgery on the wrong patient, wrong site, or wrong procedure



    • Unintended retention of a foreign object in a patient after surgery or other invasive procedures



    • Rape or assault or homicide of any patient receiving care, treatment, and services



    • Rape, assault, or homicide of a staff member, licensed independent practitioner, visitor or vendor while on site at the health care organization



    • Hemolytic transfusion reaction involving administration of blood or blood products having major blood group incompatibilities



    • Severe neonatal hyperbilirubinemia (bilirubin >30 mg/dL)



    • Prolonged fluoroscopy with cumulative dose >1500 rads to a single field or any delivery of radiotherapy to the wrong body region or >25% above the planned radiotherapy dose



    • Suicide of any patient receiving care, treatment, and services in a continuous care setting or within 72 hours of discharge





The Joint Commission’s top 10 most frequently reported sentinel events (in order) in 2015 were as follows:



  • 1.

    Unintended retention of foreign body


  • 2.

    Wrong patient, wrong site, wrong procedure


  • 3.

    Fall


  • 4.

    Suicide


  • 5.

    Delay in treatment


  • 6.

    Operative or postoperative complication


  • 7.

    Other unanticipated event (asphyxiation, burn, choked on food, drowned, found unresponsive)


  • 8.

    Criminal event


  • 9.

    Perinatal death or injury


  • 10.

    Medication error



The Joint Commission notes that the terms “sentinel event” and “medical error” are not synonymous. Not all medical errors result in sentinel events, and not all sentinel events are the result of medical errors. The Joint Commission reviews all sentinel events and mandates a root cause analysis after each.


Diagnosis Errors


In 2015, Improving Diagnosis in Health Care was published as a follow-up to the 2000 IOM report. The new report published by the National Academy of Medicine (formerly known as the IOM) focuses on diagnostic errors, a significant but poorly addressed source of medical errors that was missing from the original 2000 report. Diagnostics errors are defined as (1) the failure to establish an accurate and timely diagnosis or (2) the failure to communicate the diagnosis to the patient. An estimated 5% of adults in the United States experience a diagnostic error each year. This equates to every American experiencing at least one error in diagnosis in their lifetime. A study by Tehrani et al. in 2013 analyzed 25 years of U.S. malpractice claims and found that the majority of paid claims were for diagnostic errors (28.6%). Diagnostic errors were nearly twice as likely as other types of claims to be associated with death. The estimated 2011 inflation adjusted payout for each diagnostic error claim was $386,849.


Medication Errors ( Fig. 39.2 )


Medication errors can be grouped into several categories: wrong patient, wrong drug, wrong dose, wrong route, or wrong frequency. These errors injure more than 1.5 million patients and result in billions of additional costs annually. Common medication errors in the past were related to illegible prescriptions and orders (see Fig. 39.2 ). Fortunately, the advent of electronic medical record systems has made a significant impact.




FIG. 39.2


Illegible prescription. Can you discern the name of the first medication on this prescription? If you said Plendil, then you agreed with the pharmacist who filled the prescription. Unfortunately, the physician intended for the patient to get Isordil. This error resulted in a fatal overdose for the 42-year-old patient. A jury in Texas attributed the patient’s death to the illegible prescription. The physician and the pharmacist each paid $225,000 in compensation to the patient’s family. This was the first reported case of medical malpractice caused by illegible handwriting.

(From Charatan F. Compensation awarded for death after illegible prescription. West J Med 2000;172:80. www-ncbi-nlm-nih-gov.easyaccess1.lib.cuhk.edu.hk/pmc/articles/PMC1070756/ .)


Other medication problems stem from the lack of standardization and presence of ambiguity in labeling of medications used in hospitals. For example, the epinephrine that is used in medical emergencies for cardiac arrest and anaphylaxis is packaged in the same vial with a similar label but in different concentrations. For anaphylaxis, a lower concentration of the medication should be given intramuscularly, but for cardiac arrest, a higher concentration should be given intravenously. Inadvertently giving the wrong concentration of the medication has led to fatal outcomes. In an effort to decrease the risk of this medical error, some hospitals are stocking prefilled intramuscular dose syringes for anaphylaxis on their crash carts. Efforts used at the development and manufacturing level, such as removing or limiting the number of drugs that look alike or sound alike (e.g., Celebrex and Cerebyx), are approaches that should reduce medical errors.


Another strategy designed to reduce medication errors is the ban on the use of certain words and abbreviations when ordering medications. The “do not use” list was developed by The Joint Commission in 2004 during a 1-day summit of representatives from more than 70 professional medical organizations and special interest group. The goal of the summit was to identify abbreviations, acronyms, and symbols that have the potential to cause errors and propose a method to eliminate or reduce the threat. The result was the official “do not use” list ( Table 39.1 ). The list applies to all orders and medication-related documents that are handwritten, free texted in the computer, or on preprinted forms.



TABLE 39.1

Official “Do Not Use” List




























Do Not Use Potential Problem Use Instead
U, u (unit) Mistaken for 0 (zero), the number 4 (four), or cc Write “unit.”
IU (international unit) Mistaken for IV (intravenous) or the number 10 (ten) Write “international unit.”
Q.D., QD, q.d., qd (daily), Q.O.D., QOD, q.o.d, qod (every other day) Mistaken for each other
Period after the Q is mistaken for I, and the O is mistaken for I
Write “daily.”
Write “every other day.”
Trailing zero (X.0 mg)
Lack of leading zero (.X mg)
Decimal point is missed Write X mg
Write 0.X mg
MSMSO 4 and MgSO 4 Can mean morphine sulfate or magnesium sulfate
Confused for each other
Write “morphine sulfate.”
Write “magnesium sulfate.”


Surgical Errors ( Fig. 39.3 )


The NQF, a nonprofit organization that sets national priorities and goals for health care quality and safety, lists surgical events as one of the six major categories of “never events.” Three of the top five sentinel events reported by The Joint Commission from 2004 to 2015 were surgical events (wrong-site surgery, unintended retention of foreign body, and operative or postoperative complications).




FIG. 39.3


Retained surgical object.



To address surgical errors, The Joint Commission developed a universal protocol for preventing wrong-site, wrong-procedure, and wrong-person surgery. Endorsed by more than 40 professional medical organizations, the protocol mandates active involvement and effective communication among all members of the surgical team. It involves a verification process, marking of the surgical site, and a time-out procedure ( Box 39.4 ).


Aug 7, 2019 | Posted by in MEDICAL ASSISSTANT | Comments Off on Patient Safety and Quality of Care
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