1
ASSESSING THE BURDEN OF ERROR RECOGNITION AND MANAGEMENT ON PATIENT CARE IN CARDIAC SURGERY TEAMS Agnes Bognar MD, MBA 1 ; Robert Duncan, PhD 1 ; Julie Johnson, PhD, MSPH 2 ; David Birnbach, MD, MPH 1 ; Emile Bacha, MD 3 ; Paul Barach, MD,MPH 1 Department of Anesthesiology, Perioperative Medicine and Pain Management University of Miami/ Jackson Health System, Miami, Florida 2 Dept. of Medicine, University of Chicago, Chicago, IL; 3 Children’s Hospital, Harvard School of Medicine AIM The study aims were: • To explore the impact of human factors and medical errors on pediatric cardiac surgery team members •To assess the impact of the team culture on error recognition ABSTRACT Introduction: Pediatric cardiac surgery (PCS) is an ideal model to study the coordinated efforts of team members in a complex organizational structure. The fear of committing clinical errors in perioperative care has a negative impact on the psychological well- being of surgical team members and ultimately on patient safety. There is limited knowledge regarding the opinions of the presence and management of error by surgical team personnel. Methods: Pediatric Cardiac Surgery teams (PCS) in three major urban academic health centers participated in this study. 61 of 89 respondents completed the questionnaire (response rate = 69%) including 24 anesthesiologists, 15 nurses, 10 perfusionists, 7 surgeons, and 5 others unspecified. We used 29 questions, sorted by multi-factorial analysis to assess the attitudes and perceptions of PCS members. The domain Impact of Error, relates to the organizational and personal burdens that are direct consequences of making and anticipation of committing clinical errors. 17 of the questions came from a validated questionnaire (1) while 12 were formulated after pre- testing. Respondents indicated the extent to which they agreed with each statement on a 4-point Likert scale consisting of agree strongly, agree slightly, disagree slightly, or disagree strongly. The statistical analysis included a confirmatory factor analysis of the domain, and scale scores were computed. All analyses were carried out using SAS. Results: The confirmatory factor analysis of the three factors in the Impact of Error domain yielded a CFI of 0.73, an RMR of 0.06 and an RMSEA of 0.09. The Chi Square for fit was 440.5, 294 df, p < 0.0001. The items in Factor 1, Error Resource Management, all show agreement above 60% except for one item. Only 31% feel that levels of staffing are sufficient. In Factor 2, Risk Modification, only 47% report that equipment is adequate and fewer than 60% feel that errors due to lack of skill or knowledge are rare. According to the items in Factor 3, Error Burden, errors in this environment would appear to be omnipresent, with 91% of the respondents stating they have seen errors, 83% responding that they have made a mistake that had the potential to harm a patient, and 75% reporting being ashamed of making an error in front of the OR staff. Also, 97% of our respondents agreed that errors are important regardless of patient outcome. In this factor there was a high overall agreement across items with the exception that 41% reporting that medical errors happen every day and 39% saying that personnel often disregard rules. With the exception of the CFI, these parameters indicate a good fit of the data to the proposed structure. Discussion: The study suggests that PCS teams are aware and influenced by the error burden of clinical care. This supports observational data of 102 PCS cases about the pervasive error opportunities in PCS (2,3). Over one-third of the respondents admitted that errors occur daily and repeatedly, and that staff frequently disregard rules and procedures. The responses of this validated survey suggest several intervention opportunities. Thse results coupled with more than one-third of PCS staff admitting feeling not safe in their own OR, points to opportunities for training and the redesign of PCS care. These changes will likely lead to improve patient safety and provider well-being. METHODS Study design: This study is a continuation and expanded analysis of the preliminary results reported previously. We have now performed a more complete examination of data utilizing confirmatory factor analysis to access the validity and reliability of the modified instrument and exploratory factor analysis for newly developed items. These results have also been correlated with data collected from a qualitative survey. Study population : Pediatric cardiac surgery teams at three US academic centers. The teams included anesthesiologists (A), surgeons (S), perfusionists (P), and nurses (N). Participants anonymously completed a web-based or a paper version of the survey. IRB approval and informed consent were obtained in all locations. Survey Tool : The scaled survey instrument was based on a previously validated survey to assess healthcare culture and attitudes (1). The PCS specialties differ only with regards to the Error Burden scale (F3, 55=4.87, p=0.0046). In the pair-wise t-tests of this scale the Nurses are significantly different (p < 0.05) from the Anesthetists and Perfusionists, but not the Surgeons. OPEN ENDED QUESTIONS Respondents were asked about the human factors and systems issues that affect their satisfaction and concerns, such whether worrying about the job made it difficult to sleep at night. Thirty-seven of 57 respondents (63%) answered affirmatively and listed 65 worries. The themes of these responses are shown in Table 5. CONCLUSIONS We surveyed PCS team members to ascertain how the perception and fear of clinical errors in their work, influences their professional and personal activities. We demonstrated that in a high risk environment of pediatric cardiac surgery, errors and the potential for errors have a clear impact on healthcare providers. We found that: Team members value an environment that focuses on preventing patient harm and nurturing a culture of patient safety. Team members reported almost unanimously that they had either observed or personally made mistakes in the OR that had the potential to harm patients. This finding varies from previous studies which have not reported such striking results. Team members are willing to discuss and learn from their errors. Although they know the proper channels for reporting errors, the majority of the team members did not use these channels The PCS staff perceive scheduling and equipment problems and they feel they need more organizational support Organizational factors and personal fears of possible errors were reflected by team members in terms of their sleep patterns. LIMITATIONS This study is of limited scope and sample size and must be validated with further larger evaluations that include other surgical operating room environments and locations. REFERENCES 1. Sexton JB, et al. Frontline assessments of healthcare culture: Safety Attitudes Questionnaire norms and psychometric properties; http:// www.utpatientsafety.org ; Center of Excellence for Patient Safety, University of Texas, 2006. 2. Barach P, et al.: Anesth Analg (100) S-91, 2005. 3. Galvan C, Bacha EA, Mohr J, Barach P. A Human Factors Approach to Understanding Patient Safety During Pediatric Cardiac Surgery. Progress in Pediatric Cardiology. 2005;20(1):13-20. ACKNOWLEDGMENT Research supported by a grant from the AHA, award number 0330274N TABLE 1. Factor 1 ERROR RESOURCE MANAGEMENT N % agreed Mean Factor loading When medical errors occur they handled appropriately 53 85 1.77±0.11 0.42 Disruptions in continuity of patient care can be detrimental to patient safety 58 93 1.48±0.08 -0.48 Problems with equipment are frequent in the OR 52 69 2.17±0.14 -0.46 Our levels of staffing are sufficient to handle the number of patients 52 31 2.79±0.12 0.55 Trainees in my discipline ( e.g., nurse, residents, etc) are adequately supervised 53 79 1.83±0.11 0.53 Decision-making in our OR should include more input from other OR staff than it does now 50 74 1.96±0.11 -0.51 We have a confidential reporting system for documenting medical errors 47 85 1.65±0.13 0.42 I have used the hospital's reporting system for documenting medical errors 51 61 2.23±1.88 0.52 I am encouraged by my colleagues to report any patient safety concerns I may have 59 78 1.94±0.13 0.74 I know the proper channels to direct questions regarding patient safety in my department or work area 57 95 1.51±0.09 0.67 My department provides adequate, timely information about events in the hospital that might effect my work 59 68 2.1±0.14 0.82 TABLE 2. Factor 2 RISK MODIFICATION N % agreed Mean Factor loading The OR equipment in our hospital is adequate 53 47 2.58±0.15 0.72 I would feel perfectly safe as a patient in our OR 59 64 2.08±0.14 0.66 Errors due lack of skill are rare in OR 52 58 2.23±0.13 0.75 Errors due lack of knowledge are rare in OR 54 59 2.24±0.13 0.70 I am properly trained to use new and existing equipment in the OR 55 89 1.71±0.11 0.77 I expect to be consulted on matters that affect the performance of my duties 55 95 1.29±0.08 0.40 I am afraid to report adverse events as I might be punished or lose my job 60 12 3.57±0.1 -0.53 I am reluctant to report adverse events as I might gat a colleague/friend in trouble 60 15 3.45±0.09 -0.52 TABLE 3. Factor 3 ERROR BURDEN N % agreed Mean Factor loading Medical errors occur every day in our OR 49 41 2.75±0.15 0.45 I have seen the same mistakes occur again and again 54 33 2.9±0.15 0.55 OR personnel often disregard rules or guidelines 56 39 2.89±0.14 0.41 Errors committed during patient management are not important, as long as the patient improves 59 3 3.78±0.07 -0.43 I am more likely to err in tenser hostile situation 60 85 1.75±0.11 0.72 I have made mistakes that had the potential to harm patients 59 83 1.88±0.11 0.58 I am ashamed when I make a mistake in front of other OR staff 55 75 2.07±0.13 0.56 I have seen others make that had the potential to harm patients 58 91 1.59±0.1 0.77 There are frequent changes to the schedules 54 91 1.52±0.09 0.45 TABLE 4. Factor Scale Means ( ± standard error) by Specialty Specialty Error Management Risk Modification Error Burden Anesthesiologist (24) 2.3 ± 0.10 2.0 ± 0.13 1.9 ± 0.08 Nurses (15) 2.2 ± 0.07 1.8 ± 0.16 2.5 ± 0.15* Perfusionists (10) 2.6 ± 0.22 1.9 ± 0.18 1.9 ± 0.11 Surgeons ( 7) 2.2 ± 0.23 1.8 ± 0.21 2.0 ± 0.17 TABLE 5. Team Member Concerns Effecting Sleep Worries N=65 Respondents N=37 1. Fear of making an error or not giving the best care ( e.g., "forgetting to do something"; "making an error in clinical judgment that adversely affects patient health"; "we left the sponge in the patient" 30 (46%) 19 (51%) 2. Highly complex cases, patient outcome (e.g,. "exact management of the complex critically ill patient"; ”critical patient outcomes" 11 (17%) 10 (27%) 3. Hectic schedule, heavy caseload (e.g., "unfair or unrealistic work assignments" 11 (17%) 9 (24%) 4. Other team members performance, stress during work, external factors (e.g., "too much stress at work"; "declining caseload"; "unprofessional behaviour by others" 13 (20%) 7 (19%) RESULTS SCALED QUESTIONS In the initial factor analysis Factor 1, Error Resource Management, had 12 items, factor 2, Risk Modification, had eight items, and Factor 3, Error Burden, had nine items. After eliminating items with either low factor loadings or substantial “cross-factor” loadings, or both, a final factor staructure was produced as shown in Table 1,2, and 3. In Factor 1 named Error Resource Management, substantial agreement was found among respondents: 85% knew about the possibility of documenting medical errors through confidential reporting systems; they are encouraged to report patient safety concerns, however only 61 % used the hospital reporting system; 69% report frequent problems with equipment; only 31% think that staffing is sufficient to handle the number of patients; and, 74% recommended that there be more input from OR personnel in decision making. In Factor 2 named Risk Modification, substantial agreement was found among respondents in some areas: 89% agreed that they are properly trained to use new equipment; 95% expect to be consulted on matters that effect their performance; and, about 85% report not being afraid or reluctant to report adverse events for fear of causing problems for themselves or for colleagues. However, only 47% feel that equipment is adequate in the OR, and only 47% of the personnel would feel safe being a patient in their own OR In Factor 3 named -- Error Burden, represents the frequency and circumstances of perceived error: 41% of the respondents reported that errors in the OR occur every day; 33% reported that the same mistakes occur over and over again; 83% reported they had made mistakes; and, 91% reported seeing others make mistakes potentially harmful to patients.

ASSESSING THE BURDEN OF ERROR RECOGNITION AND MANAGEMENT ON PATIENT CARE IN CARDIAC SURGERY TEAMS Agnes Bognar MD, MBA 1 ; Robert Duncan, PhD 1 ; Julie

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Page 1: ASSESSING THE BURDEN OF ERROR RECOGNITION AND MANAGEMENT ON PATIENT CARE IN CARDIAC SURGERY TEAMS Agnes Bognar MD, MBA 1 ; Robert Duncan, PhD 1 ; Julie

ASSESSING THE BURDEN OF ERROR RECOGNITIONAND MANAGEMENT ON PATIENT CARE IN CARDIAC SURGERY TEAMS

Agnes Bognar MD, MBA1; Robert Duncan, PhD1; Julie Johnson, PhD, MSPH2; David Birnbach, MD, MPH1; Emile Bacha, MD3; Paul Barach, MD,MPH1Department of Anesthesiology, Perioperative Medicine and Pain Management University of Miami/ Jackson Health System, Miami, Florida

2Dept. of Medicine, University of Chicago, Chicago, IL; 3 Children’s Hospital, Harvard School of Medicine

AIMThe study aims were:• To explore the impact of human factors and medical errors on pediatric cardiac surgery team members•To assess the impact of the team culture on error recognition

ABSTRACTIntroduction: Pediatric cardiac surgery (PCS) is an ideal model to study the coordinated efforts of team members in a complex organizational structure. The fear of committing clinical errors in perioperative care has a negative impact on the psychological well-being of surgical team members and ultimately on patient safety. There is limited knowledge regarding the opinions of the presence and management of error by surgical team personnel. Methods: Pediatric Cardiac Surgery teams (PCS) in three major urban academic health centers participated in this study. 61 of 89 respondents completed the questionnaire (response rate = 69%) including 24 anesthesiologists, 15 nurses, 10 perfusionists, 7 surgeons, and 5 others unspecified. We used 29 questions, sorted by multi-factorial analysis to assess the attitudes and perceptions of PCS members. The domain Impact of Error, relates to the organizational and personal burdens that are direct consequences of making and anticipation of committing clinical errors. 17 of the questions came from a validated questionnaire (1) while 12 were formulated after pre-testing. Respondents indicated the extent to which they agreed with each statement on a 4-point Likert scale consisting of agree strongly, agree slightly, disagree slightly, or disagree strongly. The statistical analysis included a confirmatory factor analysis of the domain, and scale scores were computed. All analyses were carried out using SAS.

Results: The confirmatory factor analysis of the three factors in the Impact of Error domain yielded a CFI of 0.73, an RMR of 0.06 and an RMSEA of 0.09. The Chi Square for fit was 440.5, 294 df, p < 0.0001. The items in Factor 1, Error Resource Management, all show agreement above 60% except for one item. Only 31% feel that levels of staffing are sufficient. In Factor 2, Risk Modification, only 47% report that equipment is adequate and fewer than 60% feel that errors due to lack of skill or knowledge are rare. According to the items in Factor 3, Error Burden, errors in this environment would appear to be omnipresent, with 91% of the respondents stating they have seen errors, 83% responding that they have made a mistake that had the potential to harm a patient, and 75% reporting being ashamed of making an error in front of the OR staff. Also, 97% of our respondents agreed that errors are important regardless of patient outcome. In this factor there was a high overall agreement across items with the exception that 41% reporting that medical errors happen every day and 39% saying that personnel often disregard rules. With the exception of the CFI, these parameters indicate a good fit of the data to the proposed structure.

Discussion: The study suggests that PCS teams are aware and influenced by the error burden of clinical care. This supports observational data of 102 PCS cases about the pervasive error opportunities in PCS (2,3). Over one-third of the respondents admitted that errors occur daily and repeatedly, and that staff frequently disregard rules and procedures. The responses of this validated survey suggest several intervention opportunities. Thse results coupled with more than one-third of PCS staff admitting feeling not safe in their own OR, points to opportunities for training and the redesign of PCS care. These changes will likely lead to improve patient safety and provider well-being.

METHODSStudy design: This study is a continuation and expanded analysis of the preliminary results reported previously. We have now performed a more complete examination of data utilizing confirmatory factor analysis to access the validity and reliability of the modified instrument and exploratory factor analysis for newly developed items. These results have also been correlated with data collected from a qualitative survey.

Study population: Pediatric cardiac surgery teams at three US academic centers. The teams included anesthesiologists (A), surgeons (S), perfusionists (P), and nurses (N). Participants anonymously completed a web-based or a paper version of the survey. IRB approval and informed consent were obtained in all locations.

Survey Tool: The scaled survey instrument was based on a previously validated survey to assess healthcare culture and attitudes (1).Respondents reported their opinions by answering the questionnaire using a 4 point scale (“1” strongly disagree - “4” strongly agree). The survey included open-ended questions concerning job-related worries influencing their sleep.

Statistical Analysis: The statistical analysis included a confirmatory factor analysis of the domains, and scale scores were computed. All analyses were carried out using SAS.

The PCS specialties differ only with regards to the Error Burden scale (F3, 55=4.87, p=0.0046). In the pair-wise t-tests of this scale the Nurses are significantly different (p < 0.05) from the Anesthetists and Perfusionists, but not the Surgeons.

OPEN ENDED QUESTIONSRespondents were asked about the human factors and systems issues that affect their satisfaction and concerns, such whether worrying about the job made it difficult to sleep at night. Thirty-seven of 57 respondents (63%) answered affirmatively and listed 65 worries. The themes of these responses are shown in Table 5.

CONCLUSIONSWe surveyed PCS team members to ascertain how the perception and fear of clinical errors in their work, influences their professional and personal activities. We demonstrated that in a high risk environment of pediatric cardiac surgery, errors and the potential for errors have a clear impact on healthcare providers. We found that: Team members value an environment that focuses on preventing patient harm and nurturing a culture of patient safety. Team members reported almost unanimously that they had either observed or personally made mistakes in the OR that had the potential to harm patients. This finding varies from previous studies which have not reported such striking results. Team members are willing to discuss and learn from their errors. Although they know the proper channels for reporting errors, the majority of the team members did not use these channels The PCS staff perceive scheduling and equipment problems and they feel they need more organizational support Organizational factors and personal fears of possible errors were reflected by team members in terms of their sleep patterns.

LIMITATIONSThis study is of limited scope and sample size and must be validated with further larger evaluations that include other surgical operating room environments and locations.

REFERENCES1. Sexton JB, et al. Frontline assessments of healthcare culture: Safety Attitudes Questionnaire norms and

psychometric properties; http://www.utpatientsafety.org; Center of Excellence for Patient Safety, University of Texas, 2006.

2. Barach P, et al.: Anesth Analg (100) S-91, 2005.3. Galvan C, Bacha EA, Mohr J,  Barach P. A Human Factors Approach to Understanding Patient Safety During

Pediatric Cardiac Surgery. Progress in Pediatric Cardiology.

2005;20(1):13-20.

ACKNOWLEDGMENT Research supported by a grant from the AHA, award number 0330274N

TABLE 1. Factor 1 ERROR RESOURCE MANAGEMENT N % agreed MeanFactor loading

When medical errors occur they handled appropriately 53 85 1.77±0.11 0.42

Disruptions in continuity of patient care can be detrimental to patient safety 58 93 1.48±0.08 -0.48

Problems with equipment are frequent in the OR 52 69 2.17±0.14 -0.46

Our levels of staffing are sufficient to handle the number of patients 52 31 2.79±0.12 0.55

Trainees in my discipline ( e.g., nurse, residents, etc) are adequately supervised 53 79 1.83±0.11 0.53

Decision-making in our OR should include more input from other OR staff than it does now 50 74 1.96±0.11 -0.51

We have a confidential reporting system for documenting medical errors 47 85 1.65±0.13 0.42

I have used the hospital's reporting system for documenting medical errors 51 61 2.23±1.88 0.52

I am encouraged by my colleagues to report any patient safety concerns I may have 59 78 1.94±0.13 0.74

I know the proper channels to direct questions regarding patient safety in my department or work area 57 95 1.51±0.09 0.67

My department provides adequate, timely information about events in the hospital that might effect my work 59 68 2.1±0.14 0.82

TABLE 2. Factor 2 RISK MODIFICATION N % agreed Mean Factor loading

The OR equipment in our hospital is adequate 53 47 2.58±0.15 0.72

I would feel perfectly safe as a patient in our OR 59 64 2.08±0.14 0.66

Errors due lack of skill are rare in OR 52 58 2.23±0.13 0.75

Errors due lack of knowledge are rare in OR 54 59 2.24±0.13 0.70

I am properly trained to use new and existing equipment in the OR 55 89 1.71±0.11 0.77

I expect to be consulted on matters that affect the performance of my duties 55 95 1.29±0.08 0.40

I am afraid to report adverse events as I might be punished or lose my job 60 12 3.57±0.1 -0.53

I am reluctant to report adverse events as I might gat a colleague/friend in trouble 60 15 3.45±0.09 -0.52

TABLE 3. Factor 3 ERROR BURDEN N % agreed Mean Factor loading

Medical errors occur every day in our OR 49 41 2.75±0.15 0.45

I have seen the same mistakes occur again and again 54 33 2.9±0.15 0.55

OR personnel often disregard rules or guidelines 56 39 2.89±0.14 0.41

Errors committed during patient management are not important, as long as the patient improves 59 3 3.78±0.07 -0.43

I am more likely to err in tenser hostile situation 60 85 1.75±0.11 0.72

I have made mistakes that had the potential to harm patients 59 83 1.88±0.11 0.58

I am ashamed when I make a mistake in front of other OR staff 55 75 2.07±0.13 0.56

I have seen others make that had the potential to harm patients 58 91 1.59±0.1 0.77

There are frequent changes to the schedules 54 91 1.52±0.09 0.45

TABLE 4. Factor Scale Means ( ± standard error) by Specialty Specialty Error Management Risk Modification Error Burden

Anesthesiologist (24) 2.3 ± 0.10 2.0 ± 0.13 1.9 ± 0.08

Nurses (15) 2.2 ± 0.07 1.8 ± 0.16 2.5 ± 0.15*

Perfusionists (10) 2.6 ± 0.22 1.9 ± 0.18 1.9 ± 0.11

Surgeons ( 7) 2.2 ± 0.23 1.8 ± 0.21 2.0 ± 0.17

TABLE 5. Team Member Concerns Effecting Sleep Worries N=65

Respondents N=37

1. Fear of making an error or not giving the best care ( e.g., "forgetting to do something"; "making an error in clinical judgment that adversely affects patient health"; "we left the sponge in the patient" 30 (46%) 19 (51%)

2. Highly complex cases, patient outcome (e.g,. "exact management of the complex critically ill patient"; ”critical patient outcomes" 11 (17%) 10 (27%)

3. Hectic schedule, heavy caseload (e.g., "unfair or unrealistic work assignments" 11 (17%) 9 (24%)

4. Other team members performance, stress during work, external factors (e.g., "too much stress at work"; "declining caseload"; "unprofessional behaviour by others" 13 (20%) 7 (19%)

RESULTSSCALED QUESTIONS

In the initial factor analysis Factor 1, Error Resource Management, had 12 items, factor 2, Risk Modification, had eight items, and Factor 3, Error Burden, had nine items. After eliminating items with either low factor loadings or substantial “cross-factor” loadings, or both, a final factor staructure was produced as shown in Table 1,2, and 3.

In Factor 1 named Error Resource Management, substantial agreement was found among respondents: 85% knew about the possibility of documenting medical errors through confidential reporting systems; they are encouraged to report patient safety concerns, however only 61 % used the hospital reporting system; 69% report frequent problems with equipment; only 31% think that staffing is sufficient to handle the number of patients; and, 74% recommended that there be more input from OR personnel in decision making.

In Factor 2 named Risk Modification, substantial agreement was found among respondents in some areas: 89% agreed that they are properly trained to use new equipment; 95% expect to be consulted on matters that effect their performance; and, about 85% report not being afraid or reluctant to report adverse events for fear of causing problems for themselves or for colleagues. However, only 47% feel that equipment is adequate in the OR, and only 47% of the personnel would feel safe being a patient in their own OR

In Factor 3 named -- Error Burden, represents the frequency and circumstances of perceived error: 41% of the respondents reported that errors in the OR occur every day; 33% reported that the same mistakes occur over and over again; 83% reported they had made mistakes; and, 91% reported seeing others make mistakes potentially harmful to patients.