Root Cause Analysis of Blunders in Anesthesia.

The frequency of blunders perioperative because of anesthesia is expanding, and the precise occurrence is significantly thought little of practically due to underreporting. Root cause analysis of majority of anesthesia errors due to lack of knowledge, unfollow the patient procedures and guidelines, medications errors and lack of communication between the members of anesthesia team leading to morbidity or even mortality. The cornerstone in the operating room environment is the communication, especially the patient's data are accumulated and changed continuously during a patient's anesthesia. Continuous attempts for establishing Iideal strategies to reduce the incidence and chance of anesthesia errors. The advancement of a nonaccuse condition where mistakes are transparently revealed and talked about, and guidelines for naming the medication holders, vials, and ampoules are focused. All endeavors ought to be made in the revealing and anticipation of medical drug errors. It is time to incorporate electronic and digital concepts to encourage the evolution of anesthesia-related drug delivery system.

INTRODUCTION

The press and public are unforgiving of those perceived to have harmed patients as a result of seemingly basic mistakes, inattention or carelessness, and equate such mistakes with medical negligence. More than half of the public believe that suspending doctors who have committed clinical errors is an effective prevention strategy.[1]

Throughout the previous 20 years, there was an expanding center around the issue of medicinal blunders made by specialists, attendants, and paramedical staff in clinics. The report by the Institute of Medicine (IOM) in the USA, titled “To Err is Human,” evaluated that between 44,000 and 98,000 hospitalized patients bite the dust every year in the USA because of medical blunders.[2] The genuine issue was not the way to prevent terrible doctors from hurting or executing their patients; however, how to keep the great doctors from doing as such.[3]

An anesthesiologist injects around half a million different drugs in his/her professional tenure as well as with unpredictable physiological responses of anesthetized patients would not display or verbalize any symptoms that an awake patient would, such as bronchospasm, hypotension, arrhythmias, or cardiac arrest. In 2000, a report in the United Kingdom reported that medical errors caused harm (death or injury) to more than 850,000 patients admitted to National Health Service Hospitals annually.[4]

INCIDENCE

Bates et al. found 2 of every 100 inpatients experience a preventable adverse drug event, resulting in an average increase of hospital costs by $4700 per admission almost about $2.8 million annually in a 700-bed hospital.[5] The Australian Healthcare Study found adverse events (unintended injury or complication caused by health-care provider) occurred in 16.6% of hospital admissions, with 51% of these adverse events judged to be “highly preventable” as well as death incidence was around 4.9% of patients suffering an adverse event, and permanent disability in 13.7%.[6]

Webster et al.[7] performed a study on 7794 anesthesiologist responses in two hospitals; they found the frequency of drug administration error per anesthetic case was 0.0075% with the two largest categories of errors involving incorrect doses (20%) and substitutions (20%), concluding adverse drug effects (ADE) during anesthesia.

Sakaguchi et al. reported the incidence of anesthesia-related medication errors in a university hospital in Japan through 15 years and based on 64,285 anesthesia cases concluded drug errors happened in only 50 cases (0.078%) much lower from earlier reported incidence.[8] The most common types of medications associted with the incidence of errors are opioids, cardiac supports, and vasopressors; and interestingly, the responsible anesthesiologists commonly were doctors with little experience. In South Africa, Llewellyn et al.[9] reported an incidence of 0.37% incidences for 30,412 anesthetics with a conclusion that neither the experience of the anesthetist nor the emergent nature of the surgery influenced the incidence and nearly 40% of all blunders occurred due to misidentification of drug ampoules. No major complication attributable to ADE was reported. Cooper et al.[10] also found the rate of medication error during anesthesia of 0.49% (52 errors from 10,574 case forms or 1/203 anesthetics) and a two-fold increase in the rates by anesthesia-in-training providers compared to an expert doctor, most commonly due to incorrect dose and drug substitution.

Zhang et al.[11] in a prospective study in China reported a medication error rate about 0.73% (179 errors during 16,496 anesthetics), the largest category being an omission, incorrect dosage, and substitutions, collectively accounting for >65% of all errors. These led to serious complications in at least two and inadvertent intensive care admissions for five patients. When combining the three prospective study findings of Webster et al.,[7] Llewellyn et al.,[9] and Cooper et al.,[10]244 errors were reported on 51,504 administered anesthetics. That gave us a combined incidence of 1 in 211 medication errors in anesthesia practice.[12] Based on a limited number of prospective studies, the incidence of medication error in anesthetic practice ranges from 0.33% to 0.73%, and shockingly, this rate has not changed over the last 15 years.[8]

ROOT CAUSE ANALYSIS

Root cause no 1 (the complexity nature of anesthesia work)

Anesthesiologists work in a complex, rapidly changed, and stressful work environment where effective performance demands expert knowledge, appropriate problem-solving strategies, and fine motor skills. Safe anesthesia administration requires vigilance (e.g., detection of changes in patient condition),[13] time-sharing among multiple tasks and the ability to rapidly make decisions and take actions.[14] The anesthesiologist primary goals include protecting the patient from harm and facilitating surgery. Intraoperative anesthesia care is divided into induction, maintenance, and emergence.[15]

Root cause no 2 (lack of communication)

The foundation in the operating room environment is the communication, especially the patient's data are accumulated and changed constantly during a patient's anesthesia.

An analysis of over 2400 events reported due to lack of effective communication was the primary issue involved in 70% of the events and 75% of these patients died [Table 1].[1617]

Table 1

Types of system errors

Error	Example
Technical accident	Postdural puncture headache follows a properly performed spinal anesthetic
Equipment failure	Equipment malfunction results in death despite proper maintenance and checks
Communication error	Medical consultant’s report is delayed when following the usual channels of communication
Limitation of therapeutic standards	Appropriate resuscitative efforts result in the death of multiple trauma victims
Limitation of diagnostic standards	Preoperative assessment fails to predict difficult airway management
Limitation of available resources	Lack of available blood products results in death due to massive bleeding
Limitation of supervision	Attending anesthesiologist is unable to prevent a resident anesthesiologist from committing a human error because of multiple supervisory responsibilities

The Joint Commission on Accreditation of Healthcare Organizations identified breakdowns in communication is considered the leading root cause of wrong-site operations.[18] Communication is poor in surgery rises to 32%, 38% in anesthesia and surgery, and 50% between anesthesia and surgery.[19] Further obstacles such as fearing from judgment of others, or uncertainty “I am not sure I am right” can make communication even more complex leading to inhibition health-care workers from effective speaking to each other. Proper assertions are mandatory for transmitting data; whereas, indirect communication is prone to failure. Authoritative leaders may create an artificial gap around themselves suppressing upstream communications reaching them. Communicative leaders create a familiar and friendly atmosphere that allows members of the team to express their concerns. Effective communication will not avoid errors in health care but at least reduce the probability of an error will have operational consequences and decrease the possibility of injuring or killing a patient.[20] Anesthesiologists and surgeons usually speak in different terms when discussing cases. Part of the disconnect is that surgeons deal with a diagnosis requiring surgical intervention, while anesthesiologists deliver anesthesia to facilitate a surgery while simultaneously keeping risky patients organs viable.[21] The safety of anesthesia improved by an understanding of anesthetic-related deaths, the advent of better monitoring practices, improved airway management tools, sharing of safety knowledge, and peer review [Table 2].[22]

Table 2

Negligence identified by peer review

Occurrence(s)	Peer-review analysis		Injury Severity code
	Type of error	Error category
Unplanned hospital admission, perioperative myocardial infarction	Human error	Failure to seek appropriate data	4
Respiratory failure requiring reintubation after general anesthesia	Human error	Failure to seek appropriate data	3
Respiratory failure requiring reintubation after general anesthesia	Human error	Disregard of available data	3
Respiratory failure requiring reintubation after general anesthesia, bradycardia requiring treatment	Human error	Failure to seek appropriate data	3
Mortality, undetected esophageal intubation	Human error	Disregard of available data	5
Respiratory failure requiring reintubation after general anesthesia	Human error	Disregard of available data	3
Mortality, cardiac arrest under anesthesia care	Human error	Failure to seek appropriate data	5
Aspiration pneumonitis	Human error	Failure to seek appropriate data	3
Mortality, cardiac arrest while under anesthesia care	Human error	Failure to seek appropriate data	5
Failed regional anesthetic, respiratory failure requiring reintubation after general anesthesia	Human error	Failure to seek appropriate data	3
Respiratory failure requiring reintubation after general anesthesia, cardiac arrest while under anesthesia care	Human error	Failure to seek appropriate data	3
Pneumothorax requiring chest tube	Human error	Failure to seek appropriate data	3
Problems with fluid and blood product management and pulmonary edema	Human error	Failure to seek appropriate data	3

Root cause no 3 (negligence)

The classification was designed to describe each incident, including all circumstances that may have contributed to the occurrence. Not all information could be obtained for each incident. Each of the 23 major categories of the classification included multiple branches for the observed varieties of data [Tables 3 and 4].[23]

Table 3

23 major categories of information collected for each critical incident

Error or failure

Location of incident

Date of incident

Time of day

Hospital location

Patient condition before the incident

OR scheduling

Length of OR procedure

OR procedure

Anesthetic technique

Associated factors

The immediate consequence to the patient

The secondary consequence to the patient

Who discovered the incident in progress

Who discovered the incident cause

Discovery delay

Correction delay

Discovery of cause delay

Individual responsible for the incident

Involvement of interviewee

Interviewee experience at the time of interview

Related incidents

Important side comments

OR= Operating Room

Table 4

The most frequent incidents

Breathing circuit disconnection	27
Inadvertent gas flow change	22
Syringe swap	19
Gas supply problem	15
Intravenous apparatus disconnection	11
Laryngoscope malfunction	11
Premature extubation	10
Breathing circuit connection error†	9
Hypovolemia	9
Tracheal airway device position changes	7

Root cause no 4 (human-related errors)

Cooper et al. published their study about human errors as more common than equipment failure in preventable incidents, which was the first time such errors were reported systematically in the anesthesia literature.[24] On the other hand, Frederick and Cheney found that 82% of incidents were inadvertent mistakes such as “syringe swaps,” accidental changes in fresh gas flow, or unfamiliarity with equipment.[25] Initially the mechanics of medication delivery such as the use of color-coded syringe labels and barcoding of pharmaceuticals, patients, and labels as a standard measures to decrease the incidence of medications blunders. Meanwhile, both nursing and pharmacy studies looked at using two practitioners to read labels and orders.[2627] Anesthesia published a retrospective analysis titled “A survey of anesthetic misadventures” in which >8000 incident reports in a busy hospital were analyzed, finding that most incidents arose out of failure to perform a normal check, both with medications and equipment.[28] A retrospective analysis published in 1990 covered >113,000 accident reports during a 10-year period. The so inattention, failure to check, lack of vigilance, and carelessness were identified as factors[29] [Table 5].[22]

Table 5

Types of human errors

Error	Example
Improper technique	A short catheter placed in an internal jugular vein dislodges and results in hematoma formation
Misuse of equipment	Neglecting to perform the prescribed equipment check results in equipment failure that contributes to patient death
Disregard of available data	Failure to avoid known drug allergen results in unplanned hospital admission
Failure to seek appropriate data	Failure to check appropriate extubation criteria results in premature extubation, subsequent respiratory failure, and need for reintubation
Inadequate knowledge	Incorrect interpretation of hemodynamic variables results in pulmonary edema

Root cause no 5 (errors due to medications administration)

Drug mistakes in the Closed Claims Audit showed about 24% result in a fatality, while newer anesthetic medications are safer than before; drug errors in anesthesia occur relatively frequently. Most medication errors are ultimately benign; however, a subset results in significant harm or escalation in care. Consequently, vigilance plays a role in avoiding anesthetic mishaps in all cases.[1030]

The topic of medication-related errors is popular in the medical literature because such errors comprise the most common error in the medical profession, preventable medication errors result in >7000 deaths each year in hospitals alone and tens of thousands more in outpatient facilities. Bates et al.[5] reported that nearly 30% of patient injuries occurring in a teaching hospital resulted from preventable ADE's. Estimated excess hospital costs attributable per ADE were $4700 in a year. Based on this estimate, they calculated the cost related to preventable ADE's to be about $2.8 million per year for a 700-bed hospital. According to this data, the cost of preventable ADE's would extrapolate to about $2 billion across the nation's hospitals [Table 6].[2131]

Table 6

Stages of medication administration

Term	Definition
Requesting	Prescriber requests medication from the pharmacy or from medication dispensing system; this the step may be bypassed when provider obtains
	A medication directly from anesthesia
Dispensing	A pharmacist dispenses a medication directly to the provider or provider withdraws medication from the dispensing system
Preparing	Medication is prepared by a provider (e.g., drawn from the vial, placed into a labeled syringe, and diluted)
Administering	Medication reaches the patient either by
	Self-administration or administration via an anesthesia provider
Documenting	The medication and dose are documented in the anesthesia information management system
Monitoring	Following vital signs or relevant laboratories after medication administration (e.g., checking glucose after insulin administration)

Classen et al.[32] reported that 2.4 ADE's occurred per 100 hospitals admissions and estimated that about 50% of these events were preventable. Lesar et al.[33] determined that approximately 3.99 prescription errors per 100 medications ordered. Edmondson[34] reported that 0.35% of 80,000 patients in New York State hospitals suffer a disabling injury caused by medication during hospitalization. She also stated that there is an average of 1.4 medication errors per patient per stay; of these errors, 0.9% leads to serious drug complications. In the Harvard Medical practice study,[35] ADE's accounted for 19% of injuries to hospitalized patients and represented the single most common cause of injury [Table 7].[36]

Table 7

Causes of medication administration blunders in hospitals

Category	Causes
Unsafe acts	Slips and lapses
	Rule/knowledge-based mistakes
	Violations
	Others
Local workplace factors	Patient
	Policies and procedures
	Ward-based equipment
	Health and personality
	Training and experience
	Communication
	Interruption and distraction
	Workload and skill mix
	General work environment
	Medicines and supply storage
	Local working culture
	Supervision and social dynamics
Organizational decisions	High level/strategic decisions

EXAMPLES OF REPORTED INCIDENTS AND MEDICATION ERRORS

Common medication errors in anesthesia include drug swaps (thiopentone in place of antibiotics, suxamethonium in place of fentanyl or syntocinon); duplication of drugs or errors of drug dosage, particularly opioids or paracetamol in children. Residual anesthetic drugs in the IV line have devastating consequences patient had an appendectomy. On coming back to the ward had intravenous with short extension flushed with saline. Shortly after had a cardiac arrest thought that residual muscle relaxant in the line caused a respiratory arrest pursued by a cardiac arrest.

CONSEQUENCES OF MEDICATION ERRORS

Medication errors are an important cause of patient morbidity and mortality.[37] Although only 10% of medication errors due to ADE, these errors have profound implications for patients, families, and health-care providers.[38] The IOM reported 44,000–98,000 patients to die each year as a result of medical errors most of these being medication-related. Around 19% of medication errors in the intensive care unit are life-threatening and 42% are of sufficient clinical importance to warrant additional life-sustaining treatments. The human and societal burden is even greater with many patients experiencing costly and prolonged hospital stays and some patients never fully recovering to their premorbidity status.[32]

Bates et al.[5] estimated that in American hospitals, the annual cost of serious medication errors in 1995 was $2.9 million per hospital and that a 17% decrease in incidence would result in $480,000 savings per hospital. Finally, the psychological impact of errors should not be ignored.[5]

Errors erode patient, family, and public confidence in health-care organizations.[39] Memories of errors can haunt providers for a long time[40] [Table 8].[31]

Table 8

Severity of medication error

Term	Definition	Examples
Life-threatening	The event has the potential to cause symptoms that if not treated would put the patient at risk of death	More than three consecutive premature ventricular contractions
		Patient with a previous anaphylactic reaction to penicillin who is given penicillin or cefazolin
Serious	The event has the potential to cause symptoms that are associated with a serious level of harm that is not high enough to be life-threatening	Failing to administer antibiotics before incision in a person requiring antibiotics
Significant	The event has the potential to cause symptoms that while harmful to the patient pose little or no threat to the patient’s function	The patient was given insulin without subsequently checking blood glucose levels. Blood glucose levels not checked in a patient with diabetes

CONCLUSIONS AND RECOMMENDATIONS

Anesthesia blunders range from no harm up to death, while there are patients complain from sustained significant injury leading to long-term harm or death as a sequence of bad results likely damage public confidence in health-care professionals who suffer from a damaged reputation, lack of confidence, and charges of negligence

No anesthesiologist intentionally executes a mistake, but errors are unforgiving that they can cost up to human life. In an era where patients’ knowledge and awareness about diseases and their management is expanding, clinicians need to be more vigilant to avoid unfortunate outcomes and medicolegal claims

All efforts should be made in the reporting and prevention of medical drug blunders. It is time to incorporate electronic and digital concepts to encourage the evolution of anesthesia-related drug delivery system. We infer that “to err may be human, but in health care, to err repeatedly is foolish and maybe criminal”

Systems need to be engineered to reduce the likelihood of medications misidentification through approaches such as revision of standards for labeling of drug ampoules and vials and the development of advanced electronic/digital mechanisms that allow “double-checking.”[41] The contribution of the practice of anesthesia to the global problem of medication error is far from clear and very difficult to study. Efforts rely on incident reporting, the only practical approach when funding is limited, and routine anesthesia is so safe. Efforts have begun to reduce medication error without waiting for the problem to happen

In evidence-based medicine, anesthetists are looking for solutions to the problems that we may have to accept good practical reasons. Medication errors usually result from a failure of a system as well as individual.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.