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Key Concepts

Here we sort out some of the key concepts, history and background in patient safety issues.

Alarm fatigue

Diagnostic error

Drug diversion

Hospital-acquired conditions

Maintenance of Certification (MOC)

Never events

Patient safety organization

Procedure minimum, volume, frequency

Quality measure

Second-victim syndrome

Sentinel event

Surgical checklist

Unplanned readmissions reduction program

Alarm fatigue

Electronic devices that alert providers to potentially dangerous declines in a patient’s condition but have low thresholds for their prompts, sounding many false alarms. The result is that the provider ignores them all, including the one that they should not. Alarm fatigue has been named as one of the top 10 health technology hazards by the ECRI Institute, and for three of the last eight years was the number 1 hazard on that list.  Ventilator alarms are especially troublesome.

Diagnostic error

A major patient safety issue that was the subject of an extensive Institute of Medicine report in 2015 is the frequency and severity of misdiagnosis. The report elevated misdiagnosis to  a high level of harm that Estimates suggest 12 million people in the U.S. each year are affected by diagnostic error, a cost of nealry $2 billion in malpractice payouts. In a sample of autopsies, medical misdiagnoses were found in between 10% and 20%, suggesting that as many as 80,000 people die annually in the United States because they weren’t treated for the correct condition.  A recent report said one-third of medical malpractice cases about harm including death or permanent disability were spurred by a delayed or an inaccurate diagnosis. A relatively new organization, the Society to Improve Diagnosis in Medicine, has a dynamic website and holds annual conferences.

Drug diversion

Also see “serial infector.”

Use of a drug by someone for whom it was not prescribed.  In health care settings, the term increasingly refers to the illicit practice in which providers take drugs intended for patients to use themselves or give to others.  A famous case was that of David Kwiatkowski, a catheter lab technician with hepatitis C who infected 46 patients in four states.  Kwiatkowski was caught stealing syringes filled with fentanyl intended for use in heart catheterization patients in a 100-bed hospital in Exeter, New Hampshire, and refilling them with saline.  Kwiatkowski had practiced in eight states as far west as Arizona but instead of notifying authorities about suspicious behavior, he was able to just move on to the next hospital.  Not only did some patients get infected with hepatitis C, but they endured more pain than they should have during their procedures because their sedative was heavily diluted with saline.

Hospital-acquired conditions

Conditions, such as infections or pressure ulcers, that a patient gets while in a care setting such as a nursing home or hospital. Medicare now has financial penalties for hospitals that are among the 25% of those with the highest rates, a provision established by the Patient Protection and Affordable Care Act.

Maintenance of Certification (MOC)

MOC is an extremely controversial and relatively new process by which physicians who are board certified must maintain their certification through exercises and testing, long after they were first certified by a lengthy exam after they completed medical school and were first board certified. Arguments for MOC requirements include the rapidly evolving expansion of medical treatment, potential adverse events, medications and processes with which physicians, especially those who work in private practices, may not have kept up.  Arguments against MOC requirements point to the cost of taking tests and changing their practices to comply, and some strong opponents have criticized the use of the money by board certification organizations such as the American Board of Internal Medicine, the largest. Whether a physician is board certified and whether he is MOC compliant can be checked by looking up the doctor’s name on the American Board of Medical Specialties website. The ABMS keeps track of the status of physicians certified by its 24 member boards.

Never event

A phrase coined nearly two decades ago to describe devastating medical errors that should never happen, such as surgery on the wrong patient or wrong site or a device such as a sponge or a clamp that is left inside a body cavity during surgery. The definition of a never event has been expanded, and includes any death of a very healthy, low-risk patient, as defined by the American Society of Anesthesiology as a Class one, during or immediately after low-risk surgery. Such events are so preventable that Medicare in 2007 said it would no longer pay for additional costs resulting from these errors, which now number 29.

Quality measure

Processes, outcomes or organizational structures reflect how care is provide and measures for each have been scientifically verified to lead to or are likely to lead tbetter outcomes, especially when used to compare provider organizations. For example, a process measure, also called a surrogate measure, would be a hospital’s track record of providing an ECG in less than 10 minutes to a patient presenting with chest pain. Faster response is associated with higher survival in the event the patient was having a heart attack.  An outcome measure would be an organization’s 30-day mortality rate, indicating a percentage of patients with certain conditions who died after they were discharged or a percentage of patients who developed hospital-acquired infections.  A structural measure, also a surrogate measure such as whether the organization has two-way electronic medical records between physicians’ offices and affiliated hospitals, is indicative of a higher likelihood of better quality care.

Patient safety organization

Approved as PSOs by the federal Agency for Health Care Research and Quality, these organizations, such as ECRI Institute (one of the largest), work with health care organizations to define problems, hazards and errors in a way that offers legal protection so that personnel are encouraged to share learning experiences. There are 87 such PSOs listed by AHRQ.

Procedure minimum, volume, frequency

The concept that health providers, health facilities or surgery should be required to have experience with a minimum number of a certain procedure before being reimbursed by Medicare or commercial insurance, and to be able to show patient survival rates or successful outcomes for some designated period of time. The measure is frequently used to determine whether paramedics should be allowed to transport patients to hospitals with the ability to treat stroke or heart attacks, so-called stroke or STEMI receiving centers, or whether a facility should be allowed to perform organ transplants. In certain studies, higher volume has been linked to lower in-hospital death rates in a certain heart procedure, fewer complications, but the issue is controversial.

Second Victim Syndrome

A controversial term popularized by Dr. Albert Wu of Johns Hopkins School of Medicine in a journal article in 2000 to draw attention to the grief and stress providers feel when they have committed a medical error or are suspected of causing one and/or shunned by their co-workers and family.  Wu’s point was that providers should be encouraged and not blamed for mistakes, but rather embraced to help prevent the error from reoccurring. The stress and grief also can impact their ability to focus and may make subsequent errors more likely, not to mention cause fissures in their relationships with fellow caregivers.

Family members of patients harmed by medical errors are upset by this term, however, saying that they, not the health providers who caused the mistake, are the real second victims. They advocate for the abandonment of the term. 

Sentinel event

A term adopted by The Joint Commission to mean any event that affects a patient by causing death, permanent harm or severe temporary harm with intervention to sustain life. Sentinel events occur in any health facility, from medical offices where surgery is performed, labs, behavioral health facilities, nursing homes, ambulatory care settings such as emergency departments or surgery centers, and hospitals.

Sentinel events include suicide of any patient being treated in an around-the-clock care setting or within 72 hours of discharge; unanticapted death of a full-term infant; discharge of an infant to the wrong family; abduction of any patient receiving care, treatment and services; any unauthorized departure of a patient from an around-the-clock care setting that leads to death, permanent or severe temporary harm to the patient; reaction to an administration of blood or blood products due to major blood group incompatibility; rape, assault eading to death, permanent harm or severe temporary harm or homicide of any patient receiving care while on the care setting site; any invasive procedure on the wrong patient at the wrong time or that is unintended; unintended retention of a foreign object in a patient after an invasive procedure; severe neonatal hyperbilirubinemia or prolonged fluoroscopy with a cumulative dose greater than 1,500 rads to a single filed or delivery of radiotherapy to the wrong body regon or greater than 25% above the planned radiotherapy dose.

Sentinel events also include a fire, flame or unanticipated smoke, heat, or flashes during patient care, any maternal death related to the birth process or severe maternal morbidity or illness not related to a patient’s underlying condition or illness that results in permanent or severe temporary harm.

Surgical checklist

The World Health Organization created the Surgical Safety Checklist in 2009 to systematically address any issues that could lead to an error, such as whether surgeons have prepared for the correct surgery, in the correct patient, on the correct body part and on the correct side. Various aspects of the patient’s condition are addressed during three phases, the sign-in, the time out and the sign out. Use of surgical checklists were unpopular among surgeons and operating room teams at first because they were thought to be a waste of time. But their use has gradually won acceptance as the number of avoidable errors, or never events, during operations has gone down. Still, errors do occur, often due to errors, such as communication problems or delays in diagnosis or misdiagnosis that occur not during surgery but before and after the procedure.

Unplanned readmissions reduction program

Codified by the Patient Protection and Affordable Care Act, this program’s intent was to push hospitals to be more careful about discharging patients to make sure they had access to medications and supportive care at home to prevent their readmissions.  It penalizes hospitals with higher rates of readmissions within 30 days for patients discharged after treatment for such illnesses as heart attack, pneumonia and congestive heart failure. The penalty is severe, up to 3% of a hospital’s total reimbursement. But the program is controversial. Several studies suggested that hospitals that treat greater percentages of patients in lower socioeconomic brackets, who have reduced access to medications and physician care after discharge, may have been unfairly penalized. Kaiser Health News reporter Jordan Rau has kept track of this issue since the beginning, and recently published this report about penalties assessed 2,583 hospitals for higher rates of readmissions.  There is concern that hospitals may be avoiding readmitting certain patients who should be readmitted in fear of the penalty. Rau’s most recent story has links to studies that say the program has worked as well as studies that say it has not worked, and may have increased mortality in some patients.