ROOT CAUSE ANALYSIS AND ACTION PLAN FRAMEWORK TEMPLATE

ROOT CAUSE ANALYSIS AND ACTION PLAN FRAMEWORK TEMPLATE

RCA Framework

ROOT CAUSE ANALYSIS AND ACTIONPLAN FRAMEWORK TEMPLATE

The Joint Commission Root CauseAnalysis and Action Plan tool has 24 analysis questions. Thefollowing framework is intended to provide a template for answeringthe analysis questions and aid organizing the steps in a root causeanalysis. All possibilities and questions should be fully consideredin seeking “root cause(s)” and opportunities for risk reduction. Not all questions will apply in every case and there may be findingsthat emerge during the course of the analysis. Be sure however toenter a response in the “Root Cause Analysis Findings” field foreach question #. For each finding continue to ask “Why?” anddrill down further to uncover why parts of the process occurred ordidn’t occur when they should have. Significant findings that arenot identified as root causes themselves have “roots”.

Asan aid to avoid “loose ends,” the two columns on the right areprovided to be checked off for later reference:

  • “Root cause” should be answered “Yes” or “No” for each finding. A root cause is typically a finding related to a process or system that has a potential for redesign to reduce risk. If a particular finding is relevant to the event is not a root cause, be sure that it is addressed later in the analysis with a “Why?” question such as “Why did it contribute to the likelihood of the event” or “Why did it contribute to the severity of the event?” Each finding that is identified as a root cause should be considered for an action and addressed in the action plan.

  • “Plan of action” should be answered “Yes” for any finding that can reasonably be considered for a risk reduction strategy. Each item checked in this column should be addressed later in the action plan.

Whendid the event occur?

7th February 2003

Day of the week: Friday

Time: N.A

DetailedEvent Description Including Timeline:

On the said date, Duke Hospital’s surgeons erroneously transplanted a heart and lungs to a seventeen-year-old girl, Jesica Santillan. The heart and lungs were of incompatible blood type. Even after noting that the mistake had taken place, the hospital’s management, in attempt to hide from the media, made aggressive attempts to underplay the ordeal by extending the girls’ stay on life support. Some reports indicate the second transplant had taken place after the management had attempted to hide the ordeal from the media.

Diagnosis:

Restrictive cardiomyopathy and secondary nonreactive pulmonary hypertension

Medications:

Immuno-suppression drugs

AutopsyResults:

Autopsy revealed that the organs were of blood type A, and Jessica’s blood type was O-Positive. The incompatibility led to severe illness, which resulted in death.

PastMedical/Psychiatric History:

The patient had a heart condition. The condition was described by in her past medical results as restrictive cardiomyopathy and secondary nonreactive pulmonary hypertension. These conditions led to blood perfusion in her lungs. Before being admitted at the Duke University Medical Center, Jessica Santillan was living in Mexico. Her parents had crossed the border to seek medication for her condition, as it was not available in her country.

#

Analysis Question

Prompts

Root Cause Analysis Findings

Root cause

Plan of Action

1

What was the intended process flow?

List the relevant process steps as defined by the policy, procedure, protocol, or guidelines in effect at the time of the event. You may need to include multiple processes.

Note: The process steps as they occurred in the event will be entered in the next question.

Examples of defined process steps may include, but are not limited to:

  • Site verification protocol

  • Instrument, sponge, sharps count procedures

  • Patient identification protocol

  • Assessment (pain, suicide risk, physical, and psychological) procedures

  • Fall risk/fall prevention guidelines

  • Patient identification

  • Psychological and social evaluation

  • Blood tests

  • Diagnostic tests

  • Fall/risk/fall prevention guidelines

YES

2

Were there any steps in the process that did not occur as intended?

Explain in detail any deviation from the intended processes listed in Analysis Item #1 above.

The blood test procedure was not conducted.

YES

3

What human factors were relevant to the outcome?

Discuss staff-related human performance factors that contributed to the event.

Examples may include, but are not limited to:

  • Boredom

  • Failure to follow established policies/procedures

  • Fatigue

  • Inability to focus on task

  • Inattentional blindness/ confirmation bias

  • Personal problems

  • Lack of complex critical thinking skills

  • Rushing to complete task

  • Substance abuse

  • Trust

Two main human factors are related to the event. The first one is failure to follow established policies and procedures. According to organ transplant procedures and policies, the medics are supposed to closely investigate every element and ensure that there are no loopholes for mistakes that are left. Failure to do this led to the identification of wrong blood type organs for the right patient. The second human factor is wrong judgment. From the case study report, the head surgeon assumed that the CDS had confirmed the blood type before offering the organs.

YES

4

How did the equipment performance affect the outcome?

Consider all medical equipment and devices used in the course of patient care, including AED devices, crash carts, suction, oxygen, instruments, monitors, infusion equipment, etc. In your discussion, provide information on the following, as applicable:

  • Descriptions of biomedical checks

  • Availability and condition of equipment

  • Descriptions of equipment with multiple or removable pieces

  • Location of equipment and its accessibility to staff and patients

  • Staff knowledge of or education on equipment, including applicable competencies

  • Correct calibration, setting, operation of alarms, displays, and controls

Equipment performance did not affect the outcome. However, the major mistake was keeping the patient on life support for unnecessarily long.

5

What controllable environmental factors directly affected this outcome?

What environmental factors within the organization’s control affected the outcome?

Examples may include, but are not limited to:

  • Overhead paging that cannot be heard

  • Safety or security risks

  • Risks involving activities of visitors

  • Lighting or space issues

The response to this question may be addressed more globally in Question #17.This response should be specific to this event.

No controllable environmental factors involved.

6

What uncontrollable external factors influenced this outcome?

Identify any factors the organization cannot change that contributed to a breakdown in the internal process, for example natural disasters.

No controllable environmental factors involved.

7

Were there any other factors that directly influenced this outcome?

List any other factors not yet discussed.

Ignorance, as a human factor, influenced the outcome. Firstly, the surgeon assumed that the organs were of the correct blood type, and did not go ahead to confirm this assumption. Secondly, with attempts to hide the ordeal from the media and the public, the hospital’s management kept the patient unnecessarily long on life support, ignoring the negative impact this had on her already deteriorated condition.

8

What are the other areas in the organization where this could happen?

List all other areas in which the potential exists for similar circumstances. For example:

  • Inpatient surgery/outpatient surgery

  • Inpatient psychiatric care/outpatient psychiatric care

Identification of other areas within the organization that have the potential to impact patient safety in a similar manner. This information will help drive the scope of your action plan.

  • Outpatient surgery

  • Inpatient and outpatient care

  • Emergency room

  • Customer care desk

9

Was the staff properly qualified and currently competent for their responsibilities at the time of the event?

Include information on the following for all staff and providers involved in the event. Comment on the processes in place to ensure staff is competent and qualified. Examples may include but are not limited to:

  • Orientation/training

  • Competency assessment (What competencies do the staff have and how do you evaluate them?)

  • Provider and/or staff scope of practice concerns

  • Whether the provider was credentialed and privileged for the care and services he or she rendered

  • The credentialing and privileging policy and procedures

  • Provider and/or staff performance issues

The staff was adequately prepared to perform the procedure. The overseer of the procedure, Dr. James Jaggers, is an accredited professor of surgery with years of experience.

10

How did actual staffing compare with ideal levels?

Include ideal staffing ratios and actual staffing ratios along with unit census at the time of the event. Note any unusual circumstance that occurred at this time. What process is used to determine the care area’s staffing ratio, experience level and skill mix?

No staffing issues

11

What is the plan for dealing with staffing contingencies?

Include information on what the organization does during a staffing crisis, such as call-ins, bad weather or increased patient acuity.

Describe the organization’s use of alternative staffing. Examples may include, but are not limited to:

  • Agency nurses

  • Cross training

  • Float pool

  • Mandatory overtime

  • PRN pool

12

Were such contingencies a factor in this event?

If alternative staff were used, describe their orientation to the area, verification of competency and environmental familiarity.

13

Did staff performance during the event meet expectations?

Describe whether staff performed as expected within or outside of the processes. To what extent was leadership aware of any performance deviations at the time? What proactive surveillance processes are in place for leadership to identify deviations from expected processes? Include omissions in critical thinking and/or performance variance(s) from defined policy, procedure, protocol and guidelines in effect at the time.

14

To what degree was all the necessary information available when needed? Accurate? Complete? Unambiguous?

Discuss whether patient assessments were completed, shared and accessed by members of the treatment team, to include providers, according to the organizational processes.

Identify the information systems used during patient care.

Discuss to what extent the available patient information (e.g. radiology studies, lab results or medical record) was clear and sufficient to provide an adequate summary of the patient’s condition, treatment and response to treatment.

Describe staff utilization and adequacy of policy, procedure, protocol and guidelines specific to the patient care provided.

There was luck of adequate information regarding the organs that were to be used. The surgeons that were to conduct the surgery did not confirm the integrity of the information that they used, regarding the compatibility of the organs to be transplanted.

The patient’s medical history and illness records were available, and the diagnosing patients had approved the information. She had been diagnosed with restrictive cardiomyopathy and secondary nonreactive pulmonary hypertension, which was confirmed before request of the organs (Byers &amp White, 2004). The staff, especially the organ transplant department, did not however confirm the compatibility of the available organs with the patient’s system.

YES

15

To what degree was the communication among participants adequate for this situation?

Analysis of factors related to communication should include evaluation of verbal, written, electronic communication or the lack thereof. Consider the following in your response, as appropriate:

  • The timing of communication of key information

  • Misunderstandings related to language/cultural barriers, abbreviations, terminology, etc.

  • Proper completion of internal and external hand-off communication

  • Involvement of patient, family and/or significant other

There was improper completion of internal and external hand-off communication. Whilst the clinical protocols and policies indicate that every organ transplant must be accompanies with detailed organ and patient information, the surgeons involved played down this to a large degree.

YES

16

Was this the appropriate physical environment for the processes being carried out for this situation?

Consider processes that proactively manage the patient care environment. This response may correlate to the response in question 6 on a more global scale.

What evaluation tool or method is in place to evaluate process needs and mitigate physical and patient care environmental risks?

How are these process needs addressed organization-wide?

Examples may include, but are not limited to:

  • alarm audibility testing

  • evaluation of egress points

  • patient acuity level and setting of care managed across the continuum,

  • preparation of medication outside of pharmacy

17

What systems are in place to identify environmental risks?

Identify environmental risk assessments.

  • Does the current environment meet codes, specifications, regulations?

  • Does staff know how to report environmental risks?

  • Was there an environmental risk involved in the event that was not previously identified?

18

What emergency and failure- mode responses have been planned and tested?

Describe variances in expected process due to an actual emergency or failure mode response in connection to the event.

Related to this event, what safety evaluations and drills have been conducted and at what frequency (e.g. mock code blue, rapid response, behavioral emergencies, patient abduction or patient elopement)?

Emergency responses may include, but are not limited to:

  • Fire

  • External disaster

  • Mass casualty

  • Medical emergency

Failure mode responses may include, but are not limited to:

  • Computer down time

  • Diversion planning

  • Facility construction

  • Power loss

  • Utility issues

The emergency and failure-mode response for organ transplant mismatch is medication to suppress the immune response. In other cases, there is need to have a new transplant.

YES

19

How does the organization’s culture support risk reduction?

How does the overall culture encourage change, suggestions and warnings from staff regarding risky situations or problematic areas?

  • How does leadership demonstrate the organization’s culture and safety values?

  • How does the organization measure culture and safety?

  • How does leadership establish methods to identify areas of risk or access employee suggestions for change?

  • How are changes implemented?

The culture of hospitals is perceived by employees as the determiner of their conduct. The staff’s conduct is measured by continuous evaluation of their input, and adherence to the hospital’s policies and protocols. Organizational leadership, at healthcare level, is responsible for the creation of a positive working environment (Joint Commission on Accreditation of Healthcare Organizations, 2011).

YES

20

What are the barriers to communication of potential risk factors?

Describe specific barriers to effective communication among caregivers that have been identified by the organization. For example, residual intimidation or reluctance to report co-worker activity.

Identify the measures being taken to break down barriers (e.g. use of SBAR). If there are no barriers to communication discuss how this is known.

The main barrier to communication is erroneous assumption. Before the procedure, the surgeons failed to verify the organ compatibility information. According to Jagger, the head surgeon, he had failed to get the correct information from the UNOS prior to authorizing the surgery (Miller, 2003).

21

How is the prevention of adverse outcomes communicated as a high priority?

Describe the organization’s adverse outcome procedures and how leadership plays a role within those procedures.

Through the principle that patient safety is a right, hospitals in the U.S have implemented communication of unanticipated adverse outcomes (Schaider &amp Chubng, 2006 and Kissane, 2010 ). The hospital mainly applies documentation of medical reports, education and training.

YES

22

How can orientation and in-service training be revised to reduce the risk of such events in the future?

Describe how orientation and ongoing education needs of the staff are evaluated and discuss its relevance to event. (e.g. competencies, critical thinking skills, use of simulation labs, evidence based practice, etc.)

The main strategy that can be implemented to mitigate future risk is evaluation of patient reports and integration of clinical information before procedures.

YES

23

Was available technology used as intended?

Examples may include, but are not limited to:

  • CT scanning equipment

  • Electronic charting

  • Medication delivery system

  • Tele-radiology services

24

How might technology be introduced or redesigned to reduce risk in the future?

Describe any future plans for implementation or redesign. Describe the ideal technology system that can help mitigate potential adverse events in the future.

Action Plan

Organization Plan of Action

Risk Reduction Strategies

Position/Title

Responsible Party

Method: Policy, Education, Audit, Observation &amp Implementation

For each of the findings identified in the analysis as needing an action, indicate the planned action expected, implementation date and associated measure of effectiveness. OR. …

Action Item #1:

Blood tests be thoroughly conducted and information be made readily available for reference at any particular moment.

Laboratory unit

Surgery office

Revision and implementation of standard medical procedure policies

If after consideration of such a finding, a decision is made not to implement an associated risk reduction strategy, indicate the rationale for not taking action at this time.

Action Item #2:

Improvement of hospitals’ human factors that influence procedure.

Human resource department

Education and training.

Check to be sure that the selected measure will provide data that will permit assessment of the effectiveness of the action.

Action Item #3:

Communication and verification of information.

Communication department, customer care.

Implementation of updated communication protocols.

Consider whether pilot testing of a planned improvement should be conducted.

Action Item #4:

Improvements to reduce risk should ultimately be implemented in all areas where applicable, not just where the event occurred. Identify where the improvements will be implemented.

Action Item #5:

Action Item #6:

Action Item #7:

Action Item #8:

References

Byers, J. F., &amp White, S. V. (2004).&nbspPatient safety: Principles and practice. New York, NY: Springer.

Joint Commission on Accreditation of Healthcare Organizations. (2011).Comprehensive Accreditation Manual: CAMH for Hospitals: the Official Handbook. Joint Commission Resources.

Kissane, D. W. (2010).&nbspHandbook of communication in oncology and palliative care. Oxford: Oxford University Press.

Miller, M. (2003). Hospital officials detail erros that led to organ transplant mix-up. Duke Chronicles. Retrieved 29 September 2015 from http://www.dukechronicle.com/article/2003/02/hospital-officials-detail-errors-led-organ-transplant-mix

Shnaider, I., &amp Chung, F. (2006). Outcomes in day surgery.&nbspCurrent Opinion in Anesthesiology,&nbsp19(6), 622-629.

Page 5


ROOT CAUSE ANALYSIS AND ACTION PLAN FRAMEWORK TEMPLATE

ROOT CAUSE ANALYSIS AND ACTION PLAN FRAMEWORK TEMPLATE

RCA Framework

ROOT CAUSE ANALYSIS AND ACTIONPLAN FRAMEWORK TEMPLATE

The Joint Commission Root CauseAnalysis and Action Plan tool has 24 analysis questions. Thefollowing framework is intended to provide a template for answeringthe analysis questions and aid organizing the steps in a root causeanalysis. All possibilities and questions should be fully consideredin seeking “root cause(s)” and opportunities for risk reduction. Not all questions will apply in every case and there may be findingsthat emerge during the course of the analysis. Be sure however toenter a response in the “Root Cause Analysis Findings” field foreach question #. For each finding continue to ask “Why?” anddrill down further to uncover why parts of the process occurred ordidn’t occur when they should have. Significant findings that arenot identified as root causes themselves have “roots”.

Asan aid to avoid “loose ends,” the two columns on the right areprovided to be checked off for later reference:

  • “Root cause” should be answered “Yes” or “No” for each finding. A root cause is typically a finding related to a process or system that has a potential for redesign to reduce risk. If a particular finding is relevant to the event is not a root cause, be sure that it is addressed later in the analysis with a “Why?” question such as “Why did it contribute to the likelihood of the event” or “Why did it contribute to the severity of the event?” Each finding that is identified as a root cause should be considered for an action and addressed in the action plan.

  • “Plan of action” should be answered “Yes” for any finding that can reasonably be considered for a risk reduction strategy. Each item checked in this column should be addressed later in the action plan.

Whendid the event occur?

7th February 2003

Day of the week: Friday

Time: N.A

DetailedEvent Description Including Timeline:

On the said date, Duke Hospital’s surgeons erroneously transplanted a heart and lungs to a seventeen-year-old girl, Jesica Santillan. The heart and lungs were of incompatible blood type. Even after noting that the mistake had taken place, the hospital’s management, in attempt to hide from the media, made aggressive attempts to underplay the ordeal by extending the girls’ stay on life support. Some reports indicate the second transplant had taken place after the management had attempted to hide the ordeal from the media.

Diagnosis:

Restrictive cardiomyopathy and secondary nonreactive pulmonary hypertension

Medications:

Immuno-suppression drugs

AutopsyResults:

Autopsy revealed that the organs were of blood type A, and Jessica’s blood type was O-Positive. The incompatibility led to severe illness, which resulted in death.

PastMedical/Psychiatric History:

The patient had a heart condition. The condition was described by in her past medical results as restrictive cardiomyopathy and secondary nonreactive pulmonary hypertension. These conditions led to blood perfusion in her lungs. Before being admitted at the Duke University Medical Center, Jessica Santillan was living in Mexico. Her parents had crossed the border to seek medication for her condition, as it was not available in her country.

#

Analysis Question

Prompts

Root Cause Analysis Findings

Root cause

Plan of Action

1

What was the intended process flow?

List the relevant process steps as defined by the policy, procedure, protocol, or guidelines in effect at the time of the event. You may need to include multiple processes.

Note: The process steps as they occurred in the event will be entered in the next question.

Examples of defined process steps may include, but are not limited to:

  • Site verification protocol

  • Instrument, sponge, sharps count procedures

  • Patient identification protocol

  • Assessment (pain, suicide risk, physical, and psychological) procedures

  • Fall risk/fall prevention guidelines

  • Patient identification

  • Psychological and social evaluation

  • Blood tests

  • Diagnostic tests

  • Fall/risk/fall prevention guidelines

YES

2

Were there any steps in the process that did not occur as intended?

Explain in detail any deviation from the intended processes listed in Analysis Item #1 above.

The blood test procedure was not conducted.

YES

3

What human factors were relevant to the outcome?

Discuss staff-related human performance factors that contributed to the event.

Examples may include, but are not limited to:

  • Boredom

  • Failure to follow established policies/procedures

  • Fatigue

  • Inability to focus on task

  • Inattentional blindness/ confirmation bias

  • Personal problems

  • Lack of complex critical thinking skills

  • Rushing to complete task

  • Substance abuse

  • Trust

Two main human factors are related to the event. The first one is failure to follow established policies and procedures. According to organ transplant procedures and policies, the medics are supposed to closely investigate every element and ensure that there are no loopholes for mistakes that are left. Failure to do this led to the identification of wrong blood type organs for the right patient. The second human factor is wrong judgment. From the case study report, the head surgeon assumed that the CDS had confirmed the blood type before offering the organs.

YES

4

How did the equipment performance affect the outcome?

Consider all medical equipment and devices used in the course of patient care, including AED devices, crash carts, suction, oxygen, instruments, monitors, infusion equipment, etc. In your discussion, provide information on the following, as applicable:

  • Descriptions of biomedical checks

  • Availability and condition of equipment

  • Descriptions of equipment with multiple or removable pieces

  • Location of equipment and its accessibility to staff and patients

  • Staff knowledge of or education on equipment, including applicable competencies

  • Correct calibration, setting, operation of alarms, displays, and controls

Equipment performance did not affect the outcome. However, the major mistake was keeping the patient on life support for unnecessarily long.

5

What controllable environmental factors directly affected this outcome?

What environmental factors within the organization’s control affected the outcome?

Examples may include, but are not limited to:

  • Overhead paging that cannot be heard

  • Safety or security risks

  • Risks involving activities of visitors

  • Lighting or space issues

The response to this question may be addressed more globally in Question #17.This response should be specific to this event.

No controllable environmental factors involved.

6

What uncontrollable external factors influenced this outcome?

Identify any factors the organization cannot change that contributed to a breakdown in the internal process, for example natural disasters.

No controllable environmental factors involved.

7

Were there any other factors that directly influenced this outcome?

List any other factors not yet discussed.

Ignorance, as a human factor, influenced the outcome. Firstly, the surgeon assumed that the organs were of the correct blood type, and did not go ahead to confirm this assumption. Secondly, with attempts to hide the ordeal from the media and the public, the hospital’s management kept the patient unnecessarily long on life support, ignoring the negative impact this had on her already deteriorated condition.

8

What are the other areas in the organization where this could happen?

List all other areas in which the potential exists for similar circumstances. For example:

  • Inpatient surgery/outpatient surgery

  • Inpatient psychiatric care/outpatient psychiatric care

Identification of other areas within the organization that have the potential to impact patient safety in a similar manner. This information will help drive the scope of your action plan.

  • Outpatient surgery

  • Inpatient and outpatient care

  • Emergency room

  • Customer care desk

9

Was the staff properly qualified and currently competent for their responsibilities at the time of the event?

Include information on the following for all staff and providers involved in the event. Comment on the processes in place to ensure staff is competent and qualified. Examples may include but are not limited to:

  • Orientation/training

  • Competency assessment (What competencies do the staff have and how do you evaluate them?)

  • Provider and/or staff scope of practice concerns

  • Whether the provider was credentialed and privileged for the care and services he or she rendered

  • The credentialing and privileging policy and procedures

  • Provider and/or staff performance issues

The staff was adequately prepared to perform the procedure. The overseer of the procedure, Dr. James Jaggers, is an accredited professor of surgery with years of experience.

10

How did actual staffing compare with ideal levels?

Include ideal staffing ratios and actual staffing ratios along with unit census at the time of the event. Note any unusual circumstance that occurred at this time. What process is used to determine the care area’s staffing ratio, experience level and skill mix?

No staffing issues

11

What is the plan for dealing with staffing contingencies?

Include information on what the organization does during a staffing crisis, such as call-ins, bad weather or increased patient acuity.

Describe the organization’s use of alternative staffing. Examples may include, but are not limited to:

  • Agency nurses

  • Cross training

  • Float pool

  • Mandatory overtime

  • PRN pool

12

Were such contingencies a factor in this event?

If alternative staff were used, describe their orientation to the area, verification of competency and environmental familiarity.

13

Did staff performance during the event meet expectations?

Describe whether staff performed as expected within or outside of the processes. To what extent was leadership aware of any performance deviations at the time? What proactive surveillance processes are in place for leadership to identify deviations from expected processes? Include omissions in critical thinking and/or performance variance(s) from defined policy, procedure, protocol and guidelines in effect at the time.

14

To what degree was all the necessary information available when needed? Accurate? Complete? Unambiguous?

Discuss whether patient assessments were completed, shared and accessed by members of the treatment team, to include providers, according to the organizational processes.

Identify the information systems used during patient care.

Discuss to what extent the available patient information (e.g. radiology studies, lab results or medical record) was clear and sufficient to provide an adequate summary of the patient’s condition, treatment and response to treatment.

Describe staff utilization and adequacy of policy, procedure, protocol and guidelines specific to the patient care provided.

There was luck of adequate information regarding the organs that were to be used. The surgeons that were to conduct the surgery did not confirm the integrity of the information that they used, regarding the compatibility of the organs to be transplanted.

The patient’s medical history and illness records were available, and the diagnosing patients had approved the information. She had been diagnosed with restrictive cardiomyopathy and secondary nonreactive pulmonary hypertension, which was confirmed before request of the organs (Byers &amp White, 2004). The staff, especially the organ transplant department, did not however confirm the compatibility of the available organs with the patient’s system.

YES

15

To what degree was the communication among participants adequate for this situation?

Analysis of factors related to communication should include evaluation of verbal, written, electronic communication or the lack thereof. Consider the following in your response, as appropriate:

  • The timing of communication of key information

  • Misunderstandings related to language/cultural barriers, abbreviations, terminology, etc.

  • Proper completion of internal and external hand-off communication

  • Involvement of patient, family and/or significant other

There was improper completion of internal and external hand-off communication. Whilst the clinical protocols and policies indicate that every organ transplant must be accompanies with detailed organ and patient information, the surgeons involved played down this to a large degree.

YES

16

Was this the appropriate physical environment for the processes being carried out for this situation?

Consider processes that proactively manage the patient care environment. This response may correlate to the response in question 6 on a more global scale.

What evaluation tool or method is in place to evaluate process needs and mitigate physical and patient care environmental risks?

How are these process needs addressed organization-wide?

Examples may include, but are not limited to:

  • alarm audibility testing

  • evaluation of egress points

  • patient acuity level and setting of care managed across the continuum,

  • preparation of medication outside of pharmacy

17

What systems are in place to identify environmental risks?

Identify environmental risk assessments.

  • Does the current environment meet codes, specifications, regulations?

  • Does staff know how to report environmental risks?

  • Was there an environmental risk involved in the event that was not previously identified?

18

What emergency and failure- mode responses have been planned and tested?

Describe variances in expected process due to an actual emergency or failure mode response in connection to the event.

Related to this event, what safety evaluations and drills have been conducted and at what frequency (e.g. mock code blue, rapid response, behavioral emergencies, patient abduction or patient elopement)?

Emergency responses may include, but are not limited to:

  • Fire

  • External disaster

  • Mass casualty

  • Medical emergency

Failure mode responses may include, but are not limited to:

  • Computer down time

  • Diversion planning

  • Facility construction

  • Power loss

  • Utility issues

The emergency and failure-mode response for organ transplant mismatch is medication to suppress the immune response. In other cases, there is need to have a new transplant.

YES

19

How does the organization’s culture support risk reduction?

How does the overall culture encourage change, suggestions and warnings from staff regarding risky situations or problematic areas?

  • How does leadership demonstrate the organization’s culture and safety values?

  • How does the organization measure culture and safety?

  • How does leadership establish methods to identify areas of risk or access employee suggestions for change?

  • How are changes implemented?

The culture of hospitals is perceived by employees as the determiner of their conduct. The staff’s conduct is measured by continuous evaluation of their input, and adherence to the hospital’s policies and protocols. Organizational leadership, at healthcare level, is responsible for the creation of a positive working environment (Joint Commission on Accreditation of Healthcare Organizations, 2011).

YES

20

What are the barriers to communication of potential risk factors?

Describe specific barriers to effective communication among caregivers that have been identified by the organization. For example, residual intimidation or reluctance to report co-worker activity.

Identify the measures being taken to break down barriers (e.g. use of SBAR). If there are no barriers to communication discuss how this is known.

The main barrier to communication is erroneous assumption. Before the procedure, the surgeons failed to verify the organ compatibility information. According to Jagger, the head surgeon, he had failed to get the correct information from the UNOS prior to authorizing the surgery (Miller, 2003).

21

How is the prevention of adverse outcomes communicated as a high priority?

Describe the organization’s adverse outcome procedures and how leadership plays a role within those procedures.

Through the principle that patient safety is a right, hospitals in the U.S have implemented communication of unanticipated adverse outcomes (Schaider &amp Chubng, 2006 and Kissane, 2010 ). The hospital mainly applies documentation of medical reports, education and training.

YES

22

How can orientation and in-service training be revised to reduce the risk of such events in the future?

Describe how orientation and ongoing education needs of the staff are evaluated and discuss its relevance to event. (e.g. competencies, critical thinking skills, use of simulation labs, evidence based practice, etc.)

The main strategy that can be implemented to mitigate future risk is evaluation of patient reports and integration of clinical information before procedures.

YES

23

Was available technology used as intended?

Examples may include, but are not limited to:

  • CT scanning equipment

  • Electronic charting

  • Medication delivery system

  • Tele-radiology services

24

How might technology be introduced or redesigned to reduce risk in the future?

Describe any future plans for implementation or redesign. Describe the ideal technology system that can help mitigate potential adverse events in the future.

Action Plan

Organization Plan of Action

Risk Reduction Strategies

Position/Title

Responsible Party

Method: Policy, Education, Audit, Observation &amp Implementation

For each of the findings identified in the analysis as needing an action, indicate the planned action expected, implementation date and associated measure of effectiveness. OR. …

Action Item #1:

Blood tests be thoroughly conducted and information be made readily available for reference at any particular moment.

Laboratory unit

Surgery office

Revision and implementation of standard medical procedure policies

If after consideration of such a finding, a decision is made not to implement an associated risk reduction strategy, indicate the rationale for not taking action at this time.

Action Item #2:

Improvement of hospitals’ human factors that influence procedure.

Human resource department

Education and training.

Check to be sure that the selected measure will provide data that will permit assessment of the effectiveness of the action.

Action Item #3:

Communication and verification of information.

Communication department, customer care.

Implementation of updated communication protocols.

Consider whether pilot testing of a planned improvement should be conducted.

Action Item #4:

Improvements to reduce risk should ultimately be implemented in all areas where applicable, not just where the event occurred. Identify where the improvements will be implemented.

Action Item #5:

Action Item #6:

Action Item #7:

Action Item #8:

References

Byers, J. F., &amp White, S. V. (2004).&nbspPatient safety: Principles and practice. New York, NY: Springer.

Joint Commission on Accreditation of Healthcare Organizations. (2011).Comprehensive Accreditation Manual: CAMH for Hospitals: the Official Handbook. Joint Commission Resources.

Kissane, D. W. (2010).&nbspHandbook of communication in oncology and palliative care. Oxford: Oxford University Press.

Miller, M. (2003). Hospital officials detail erros that led to organ transplant mix-up. Duke Chronicles. Retrieved 29 September 2015 from http://www.dukechronicle.com/article/2003/02/hospital-officials-detail-errors-led-organ-transplant-mix

Shnaider, I., &amp Chung, F. (2006). Outcomes in day surgery.&nbspCurrent Opinion in Anesthesiology,&nbsp19(6), 622-629.

Page 5


ROOT CAUSE ANALYSIS AND ACTION PLAN FRAMEWORK TEMPLATE

ROOT CAUSE ANALYSIS AND ACTION PLAN FRAMEWORK TEMPLATE

RCA Framework

ROOT CAUSE ANALYSIS AND ACTIONPLAN FRAMEWORK TEMPLATE

The Joint Commission Root CauseAnalysis and Action Plan tool has 24 analysis questions. Thefollowing framework is intended to provide a template for answeringthe analysis questions and aid organizing the steps in a root causeanalysis. All possibilities and questions should be fully consideredin seeking “root cause(s)” and opportunities for risk reduction. Not all questions will apply in every case and there may be findingsthat emerge during the course of the analysis. Be sure however toenter a response in the “Root Cause Analysis Findings” field foreach question #. For each finding continue to ask “Why?” anddrill down further to uncover why parts of the process occurred ordidn’t occur when they should have. Significant findings that arenot identified as root causes themselves have “roots”.

Asan aid to avoid “loose ends,” the two columns on the right areprovided to be checked off for later reference:

  • “Root cause” should be answered “Yes” or “No” for each finding. A root cause is typically a finding related to a process or system that has a potential for redesign to reduce risk. If a particular finding is relevant to the event is not a root cause, be sure that it is addressed later in the analysis with a “Why?” question such as “Why did it contribute to the likelihood of the event” or “Why did it contribute to the severity of the event?” Each finding that is identified as a root cause should be considered for an action and addressed in the action plan.

  • “Plan of action” should be answered “Yes” for any finding that can reasonably be considered for a risk reduction strategy. Each item checked in this column should be addressed later in the action plan.

Whendid the event occur?

7th February 2003

Day of the week: Friday

Time: N.A

DetailedEvent Description Including Timeline:

On the said date, Duke Hospital’s surgeons erroneously transplanted a heart and lungs to a seventeen-year-old girl, Jesica Santillan. The heart and lungs were of incompatible blood type. Even after noting that the mistake had taken place, the hospital’s management, in attempt to hide from the media, made aggressive attempts to underplay the ordeal by extending the girls’ stay on life support. Some reports indicate the second transplant had taken place after the management had attempted to hide the ordeal from the media.

Diagnosis:

Restrictive cardiomyopathy and secondary nonreactive pulmonary hypertension

Medications:

Immuno-suppression drugs

AutopsyResults:

Autopsy revealed that the organs were of blood type A, and Jessica’s blood type was O-Positive. The incompatibility led to severe illness, which resulted in death.

PastMedical/Psychiatric History:

The patient had a heart condition. The condition was described by in her past medical results as restrictive cardiomyopathy and secondary nonreactive pulmonary hypertension. These conditions led to blood perfusion in her lungs. Before being admitted at the Duke University Medical Center, Jessica Santillan was living in Mexico. Her parents had crossed the border to seek medication for her condition, as it was not available in her country.

#

Analysis Question

Prompts

Root Cause Analysis Findings

Root cause

Plan of Action

1

What was the intended process flow?

List the relevant process steps as defined by the policy, procedure, protocol, or guidelines in effect at the time of the event. You may need to include multiple processes.

Note: The process steps as they occurred in the event will be entered in the next question.

Examples of defined process steps may include, but are not limited to:

  • Site verification protocol

  • Instrument, sponge, sharps count procedures

  • Patient identification protocol

  • Assessment (pain, suicide risk, physical, and psychological) procedures

  • Fall risk/fall prevention guidelines

  • Patient identification

  • Psychological and social evaluation

  • Blood tests

  • Diagnostic tests

  • Fall/risk/fall prevention guidelines

YES

2

Were there any steps in the process that did not occur as intended?

Explain in detail any deviation from the intended processes listed in Analysis Item #1 above.

The blood test procedure was not conducted.

YES

3

What human factors were relevant to the outcome?

Discuss staff-related human performance factors that contributed to the event.

Examples may include, but are not limited to:

  • Boredom

  • Failure to follow established policies/procedures

  • Fatigue

  • Inability to focus on task

  • Inattentional blindness/ confirmation bias

  • Personal problems

  • Lack of complex critical thinking skills

  • Rushing to complete task

  • Substance abuse

  • Trust

Two main human factors are related to the event. The first one is failure to follow established policies and procedures. According to organ transplant procedures and policies, the medics are supposed to closely investigate every element and ensure that there are no loopholes for mistakes that are left. Failure to do this led to the identification of wrong blood type organs for the right patient. The second human factor is wrong judgment. From the case study report, the head surgeon assumed that the CDS had confirmed the blood type before offering the organs.

YES

4

How did the equipment performance affect the outcome?

Consider all medical equipment and devices used in the course of patient care, including AED devices, crash carts, suction, oxygen, instruments, monitors, infusion equipment, etc. In your discussion, provide information on the following, as applicable:

  • Descriptions of biomedical checks

  • Availability and condition of equipment

  • Descriptions of equipment with multiple or removable pieces

  • Location of equipment and its accessibility to staff and patients

  • Staff knowledge of or education on equipment, including applicable competencies

  • Correct calibration, setting, operation of alarms, displays, and controls

Equipment performance did not affect the outcome. However, the major mistake was keeping the patient on life support for unnecessarily long.

5

What controllable environmental factors directly affected this outcome?

What environmental factors within the organization’s control affected the outcome?

Examples may include, but are not limited to:

  • Overhead paging that cannot be heard

  • Safety or security risks

  • Risks involving activities of visitors

  • Lighting or space issues

The response to this question may be addressed more globally in Question #17.This response should be specific to this event.

No controllable environmental factors involved.

6

What uncontrollable external factors influenced this outcome?

Identify any factors the organization cannot change that contributed to a breakdown in the internal process, for example natural disasters.

No controllable environmental factors involved.

7

Were there any other factors that directly influenced this outcome?

List any other factors not yet discussed.

Ignorance, as a human factor, influenced the outcome. Firstly, the surgeon assumed that the organs were of the correct blood type, and did not go ahead to confirm this assumption. Secondly, with attempts to hide the ordeal from the media and the public, the hospital’s management kept the patient unnecessarily long on life support, ignoring the negative impact this had on her already deteriorated condition.

8

What are the other areas in the organization where this could happen?

List all other areas in which the potential exists for similar circumstances. For example:

  • Inpatient surgery/outpatient surgery

  • Inpatient psychiatric care/outpatient psychiatric care

Identification of other areas within the organization that have the potential to impact patient safety in a similar manner. This information will help drive the scope of your action plan.

  • Outpatient surgery

  • Inpatient and outpatient care

  • Emergency room

  • Customer care desk

9

Was the staff properly qualified and currently competent for their responsibilities at the time of the event?

Include information on the following for all staff and providers involved in the event. Comment on the processes in place to ensure staff is competent and qualified. Examples may include but are not limited to:

  • Orientation/training

  • Competency assessment (What competencies do the staff have and how do you evaluate them?)

  • Provider and/or staff scope of practice concerns

  • Whether the provider was credentialed and privileged for the care and services he or she rendered

  • The credentialing and privileging policy and procedures

  • Provider and/or staff performance issues

The staff was adequately prepared to perform the procedure. The overseer of the procedure, Dr. James Jaggers, is an accredited professor of surgery with years of experience.

10

How did actual staffing compare with ideal levels?

Include ideal staffing ratios and actual staffing ratios along with unit census at the time of the event. Note any unusual circumstance that occurred at this time. What process is used to determine the care area’s staffing ratio, experience level and skill mix?

No staffing issues

11

What is the plan for dealing with staffing contingencies?

Include information on what the organization does during a staffing crisis, such as call-ins, bad weather or increased patient acuity.

Describe the organization’s use of alternative staffing. Examples may include, but are not limited to:

  • Agency nurses

  • Cross training

  • Float pool

  • Mandatory overtime

  • PRN pool

12

Were such contingencies a factor in this event?

If alternative staff were used, describe their orientation to the area, verification of competency and environmental familiarity.

13

Did staff performance during the event meet expectations?

Describe whether staff performed as expected within or outside of the processes. To what extent was leadership aware of any performance deviations at the time? What proactive surveillance processes are in place for leadership to identify deviations from expected processes? Include omissions in critical thinking and/or performance variance(s) from defined policy, procedure, protocol and guidelines in effect at the time.

14

To what degree was all the necessary information available when needed? Accurate? Complete? Unambiguous?

Discuss whether patient assessments were completed, shared and accessed by members of the treatment team, to include providers, according to the organizational processes.

Identify the information systems used during patient care.

Discuss to what extent the available patient information (e.g. radiology studies, lab results or medical record) was clear and sufficient to provide an adequate summary of the patient’s condition, treatment and response to treatment.

Describe staff utilization and adequacy of policy, procedure, protocol and guidelines specific to the patient care provided.

There was luck of adequate information regarding the organs that were to be used. The surgeons that were to conduct the surgery did not confirm the integrity of the information that they used, regarding the compatibility of the organs to be transplanted.

The patient’s medical history and illness records were available, and the diagnosing patients had approved the information. She had been diagnosed with restrictive cardiomyopathy and secondary nonreactive pulmonary hypertension, which was confirmed before request of the organs (Byers &amp White, 2004). The staff, especially the organ transplant department, did not however confirm the compatibility of the available organs with the patient’s system.

YES

15

To what degree was the communication among participants adequate for this situation?

Analysis of factors related to communication should include evaluation of verbal, written, electronic communication or the lack thereof. Consider the following in your response, as appropriate:

  • The timing of communication of key information

  • Misunderstandings related to language/cultural barriers, abbreviations, terminology, etc.

  • Proper completion of internal and external hand-off communication

  • Involvement of patient, family and/or significant other

There was improper completion of internal and external hand-off communication. Whilst the clinical protocols and policies indicate that every organ transplant must be accompanies with detailed organ and patient information, the surgeons involved played down this to a large degree.

YES

16

Was this the appropriate physical environment for the processes being carried out for this situation?

Consider processes that proactively manage the patient care environment. This response may correlate to the response in question 6 on a more global scale.

What evaluation tool or method is in place to evaluate process needs and mitigate physical and patient care environmental risks?

How are these process needs addressed organization-wide?

Examples may include, but are not limited to:

  • alarm audibility testing

  • evaluation of egress points

  • patient acuity level and setting of care managed across the continuum,

  • preparation of medication outside of pharmacy

17

What systems are in place to identify environmental risks?

Identify environmental risk assessments.

  • Does the current environment meet codes, specifications, regulations?

  • Does staff know how to report environmental risks?

  • Was there an environmental risk involved in the event that was not previously identified?

18

What emergency and failure- mode responses have been planned and tested?

Describe variances in expected process due to an actual emergency or failure mode response in connection to the event.

Related to this event, what safety evaluations and drills have been conducted and at what frequency (e.g. mock code blue, rapid response, behavioral emergencies, patient abduction or patient elopement)?

Emergency responses may include, but are not limited to:

  • Fire

  • External disaster

  • Mass casualty

  • Medical emergency

Failure mode responses may include, but are not limited to:

  • Computer down time

  • Diversion planning

  • Facility construction

  • Power loss

  • Utility issues

The emergency and failure-mode response for organ transplant mismatch is medication to suppress the immune response. In other cases, there is need to have a new transplant.

YES

19

How does the organization’s culture support risk reduction?

How does the overall culture encourage change, suggestions and warnings from staff regarding risky situations or problematic areas?

  • How does leadership demonstrate the organization’s culture and safety values?

  • How does the organization measure culture and safety?

  • How does leadership establish methods to identify areas of risk or access employee suggestions for change?

  • How are changes implemented?

The culture of hospitals is perceived by employees as the determiner of their conduct. The staff’s conduct is measured by continuous evaluation of their input, and adherence to the hospital’s policies and protocols. Organizational leadership, at healthcare level, is responsible for the creation of a positive working environment (Joint Commission on Accreditation of Healthcare Organizations, 2011).

YES

20

What are the barriers to communication of potential risk factors?

Describe specific barriers to effective communication among caregivers that have been identified by the organization. For example, residual intimidation or reluctance to report co-worker activity.

Identify the measures being taken to break down barriers (e.g. use of SBAR). If there are no barriers to communication discuss how this is known.

The main barrier to communication is erroneous assumption. Before the procedure, the surgeons failed to verify the organ compatibility information. According to Jagger, the head surgeon, he had failed to get the correct information from the UNOS prior to authorizing the surgery (Miller, 2003).

21

How is the prevention of adverse outcomes communicated as a high priority?

Describe the organization’s adverse outcome procedures and how leadership plays a role within those procedures.

Through the principle that patient safety is a right, hospitals in the U.S have implemented communication of unanticipated adverse outcomes (Schaider &amp Chubng, 2006 and Kissane, 2010 ). The hospital mainly applies documentation of medical reports, education and training.

YES

22

How can orientation and in-service training be revised to reduce the risk of such events in the future?

Describe how orientation and ongoing education needs of the staff are evaluated and discuss its relevance to event. (e.g. competencies, critical thinking skills, use of simulation labs, evidence based practice, etc.)

The main strategy that can be implemented to mitigate future risk is evaluation of patient reports and integration of clinical information before procedures.

YES

23

Was available technology used as intended?

Examples may include, but are not limited to:

  • CT scanning equipment

  • Electronic charting

  • Medication delivery system

  • Tele-radiology services

24

How might technology be introduced or redesigned to reduce risk in the future?

Describe any future plans for implementation or redesign. Describe the ideal technology system that can help mitigate potential adverse events in the future.

Action Plan

Organization Plan of Action

Risk Reduction Strategies

Position/Title

Responsible Party

Method: Policy, Education, Audit, Observation &amp Implementation

For each of the findings identified in the analysis as needing an action, indicate the planned action expected, implementation date and associated measure of effectiveness. OR. …

Action Item #1:

Blood tests be thoroughly conducted and information be made readily available for reference at any particular moment.

Laboratory unit

Surgery office

Revision and implementation of standard medical procedure policies

If after consideration of such a finding, a decision is made not to implement an associated risk reduction strategy, indicate the rationale for not taking action at this time.

Action Item #2:

Improvement of hospitals’ human factors that influence procedure.

Human resource department

Education and training.

Check to be sure that the selected measure will provide data that will permit assessment of the effectiveness of the action.

Action Item #3:

Communication and verification of information.

Communication department, customer care.

Implementation of updated communication protocols.

Consider whether pilot testing of a planned improvement should be conducted.

Action Item #4:

Improvements to reduce risk should ultimately be implemented in all areas where applicable, not just where the event occurred. Identify where the improvements will be implemented.

Action Item #5:

Action Item #6:

Action Item #7:

Action Item #8:

References

Byers, J. F., &amp White, S. V. (2004).&nbspPatient safety: Principles and practice. New York, NY: Springer.

Joint Commission on Accreditation of Healthcare Organizations. (2011).Comprehensive Accreditation Manual: CAMH for Hospitals: the Official Handbook. Joint Commission Resources.

Kissane, D. W. (2010).&nbspHandbook of communication in oncology and palliative care. Oxford: Oxford University Press.

Miller, M. (2003). Hospital officials detail erros that led to organ transplant mix-up. Duke Chronicles. Retrieved 29 September 2015 from http://www.dukechronicle.com/article/2003/02/hospital-officials-detail-errors-led-organ-transplant-mix

Shnaider, I., &amp Chung, F. (2006). Outcomes in day surgery.&nbspCurrent Opinion in Anesthesiology,&nbsp19(6), 622-629.

Page 5