SICU Journal Club: The Critical Care Safety Study July 25, 2007 Christopher J. Utz, MD

Institute of Medicine report estimated medical errors cause 44,000-98,000 deaths each year Critical care may incur higher rates of medical error Critically ill patients may be more vulnerable to iatrogenic injury Background:

Institute of Medicine report estimated medical errors cause 44,000-98,000 deaths each year

Critical care may incur higher rates of medical error

Critically ill patients may be more vulnerable to iatrogenic injury

Study Objectives Primary: Determine the incidence and rates of adverse events and serious errors per 1000 patient-days Secondary: Categorize types of errors Identify Human factors and system factors associated with errors

Primary: Determine the incidence and rates of adverse events and serious errors per 1000 patient-days

Secondary:

Categorize types of errors

Identify Human factors and system factors associated with errors

Methods Definitions Adverse Event – any injury due to medical management, rather than the underlying disease Nonpreventable adverse event – unavoidable injury due to appropriate medical care Preventable adverse event – injury due to a nonintercepted serious error in medical care Medical Error – failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim Serious medical error – a medical error that causes harm (or injury) or has the potential to cause harm.

Definitions

Adverse Event – any injury due to medical management, rather than the underlying disease

Nonpreventable adverse event – unavoidable injury due to appropriate medical care

Preventable adverse event – injury due to a nonintercepted serious error in medical care

Medical Error – failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim

Serious medical error – a medical error that causes harm (or injury) or has the potential to cause harm.

Methods Definitions Adverse Event – any injury due to medical management, rather than the underlying disease Nonpreventable adverse event – unavoidable injury due to appropriate medical care Preventable adverse event – injury due to a nonintercepted serious error in medical care Medical Error – failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim Serious medical error – a medical error that causes harm (or injury) or has the potential to cause harm. Intercepted serious error – serious medical error that is caught before reaching the patient Nonintercepted serious error – serious medical error that reaches the patient but because of good fortune or because the patient had sufficient reserves to buffer the error, it did not cause clinically detectable harm.

Definitions

Adverse Event – any injury due to medical management, rather than the underlying disease

Nonpreventable adverse event – unavoidable injury due to appropriate medical care

Preventable adverse event – injury due to a nonintercepted serious error in medical care

Medical Error – failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim

Serious medical error – a medical error that causes harm (or injury) or has the potential to cause harm.

Intercepted serious error – serious medical error that is caught before reaching the patient

Nonintercepted serious error – serious medical error that reaches the patient but because of good fortune or because the patient had sufficient reserves to buffer the error, it did not cause clinically detectable harm.

Methods 10 beds each w/ closed attending model Adult patients – boarders & patients with < 4 hour stay excluded Patients followed until transfer, unit discharge, or death Patient population: MICU & CCU of 720 bed tertiary care hospital

10 beds each w/ closed attending model

Adult patients – boarders & patients with < 4 hour stay excluded

Patients followed until transfer, unit discharge, or death

Methods 4 pronged data collection: Direct continuous observation of on-call interns both day and night by research physicians Interns responsible for new admissions and entire unit overnight (on call Q 3 days) Activities of interest – PE, order entry, teaching & work rounds, medical procedures, & interpretation of test results Anonymous & formal incident reports Computerized adverse drug event detection monitor Chart review and abstraction by trained research nurses

4 pronged data collection:

Direct continuous observation of on-call interns both day and night by research physicians

Interns responsible for new admissions and entire unit overnight (on call Q 3 days)

Activities of interest – PE, order entry, teaching & work rounds, medical procedures, & interpretation of test results

Anonymous & formal incident reports

Computerized adverse drug event detection monitor

Chart review and abstraction by trained research nurses

Data Classification 2 physician investigators independently classified each incident Judged severity on 4-point scale (significant, severe, life-threatening, fatal) Classified events as preventable or not preventable Errors classified according to clinical activity (prevention, diagnosis, treatment, procedures, monitoring, & communicating clinical information) Further classified by individual and system based factors Rater disagreements resolved by discussion Methods

Data Classification

2 physician investigators independently classified each incident

Judged severity on 4-point scale (significant, severe, life-threatening, fatal)

Classified events as preventable or not preventable

Errors classified according to clinical activity (prevention, diagnosis, treatment, procedures, monitoring, & communicating clinical information)

Further classified by individual and system based factors

Rater disagreements resolved by discussion

Results Data collected during nine 3-wk periods (5 in MICU, 4 in CCU) Observed 391 patients 420 admissions 1490 patient-days Patient demographics are different between MICU and CCU

Results 120 Adverse events in 79 patients (20.2%) – rate of 81 adverse events/1000 pt-days 6.4% of patients had multiple events 45% of adverse events were judged to be preventable 223 Serious errors – rate of 150 serious errors/1000 pt-days

120 Adverse events in 79 patients (20.2%) – rate of 81 adverse events/1000 pt-days

6.4% of patients had multiple events

45% of adverse events were judged to be preventable

Results 16 life-threatening and 2 fatal adverse events Fatal events due to catheter-related bloodstream infections 24 serious errors judged to be potentially life-threatening

16 life-threatening and 2 fatal adverse events

Fatal events due to catheter-related bloodstream infections

Results Incident Stats: Discovery of Adverse events & nonintercepted serious errors Patient’s nurse (36%) Another physician (27%) Clinical pharmacist (12%) Responsible physician (9%) Chart review (11%) Intercepted serious errors Patient’s nurse (42%) Another physician (23%) Clinical pharmacist (17%) Majority of incidents occurred during routine care (91%) w/ far fewer w/in 30 min of admission to the unit (4%) or during an emergency intervention (2%)

Majority of incidents occurred during routine care (91%) w/ far fewer

w/in 30 min of admission to the unit (4%) or

during an emergency intervention (2%)

Results 56 (47%) of adverse events due to ADE including 19 preventable ADE’s Medications contributed to 78% of serious errors Medication errors most commonly associated w/ treatment (87%) Also associated w/ prevention, diagnosis, & monitoring

Results Human & System Factors Incidents due to errors most common during treatments & procedures (75%) – particularly the ordering or execution of medications (61%) reporting or communicating clinical info (14%) failure to take precautions or follow protocol during preventive or diagnostic activities (11%) failure to take precautions or follow protocol during treatment or procedure activities (8%) Performance level failures judged as Skill-based slips & lapses (53%) knowledge-based mistakes (26%) rule-based mistakes (5%) Sterility hazards failure to wash hands (51%) failure to use complete cap, gown, & gloves (16%) failure to properly use sterile drapes (6%) sterile field violations (17%)

Incidents due to errors most common during

treatments & procedures (75%) – particularly the ordering or execution of medications (61%)

reporting or communicating clinical info (14%)

failure to take precautions or follow protocol during preventive or diagnostic activities (11%)

failure to take precautions or follow protocol during treatment or procedure activities (8%)

Performance level failures judged as

Skill-based slips & lapses (53%)

knowledge-based mistakes (26%)

rule-based mistakes (5%)

Sterility hazards

failure to wash hands (51%)

failure to use complete cap, gown, & gloves (16%)

failure to properly use sterile drapes (6%)

sterile field violations (17%)

Discussion Results comparable to prior MICU studies w/ similar definitions Error rates similar in MICU and CCU Most of the errors categorized as slips & lapses – failure to carry out intended plans of action Based on this study, the authors estimate that 148,000 life-threatening intercepted & nonintercepted serious errors occur annually in teaching hospitals Authors focus on system-based changes as a means for error prevention Computerized physician order entry Bar-coded medication administration

Authors focus on system-based changes as a means for error prevention

Computerized physician order entry

Bar-coded medication administration

Discussion Study limitations Primarily studied interns May not be generalizable to ICU’s w/ markedly different patient populations May not be generalizable to non-teaching ICU’s

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