Root Cause Analysis Theory and Practical Application of adverse event investigations MG Schoon

Definition Any event in the chain of causes that, when acted upon by a solution, prevents the problem from recurring.Purpose Identify causative factors and develop corrective strategies To prevent adverse events/outcomes Prevent harm Improve quality care and patient safety

Near miss A patient safety incident that did not cause harm Near miss in pregnancy Adverse outcome that did not result in death

PATIENT SAFETY PREVENTION/ IMPROVEMENT TOOLS Patient satisfaction survey Patient complaints Adverse events assessments Dashboards/ trend analysis (trigger tools) Clinical audits Clinical case reviews Clinical guidelines & protocols Checklists Fire drills/ simulation exercises

Patient safety culture Patient safety is everybody’s business

ROOT CAUSE ANALYSIS An effective tool for systematically identifying problems and analysing critical incidents to generate systems improvements

ROOT CAUSE ANALYSIS Find out: What happened Why did it happen What can be done to reduce the likelihood of a recurrence

Cases that should not be subjected to RCA Events thought to be the result of a criminal act Purposefully unsafe acts (intended to cause harm) Acts related to substance abuse Events involving suspected patient abuse of any kind

Strong support from upper management It must be accepted that results of any given root cause analysis will be for improving situations, not for assigning blame Berry & Krizek

RCA 1. is inter-disciplinary, involving experts from the frontline services; 2. involves those who are the most familiar with the situation; 3. continually digs deeper by asking why, why, why at each level of cause and effect; 4. identifies changes that need to be made to systems; and 5. is as impartial as possible in order to make clear the need to be aware of and sensitive to potential conflicts of interest

Success depends on involvement of the attending physician, consulting specialist and other providers

Check for eligibility for RCA Deliberate harm test –whether the actions were as intended, not whether the outcome was as intended Incapacity test –Was a staff member ill or intoxicated Foresight test –Did the individual depart from agreed protocols or safe procedures? Substitution test –Would another individual coming from the same professional group, possessing comparable qualifications and experience, behave in the same way in similar circumstances?

RCA Steps Collect information Causal factor charting Root cause identification Recommendations

Overview of RCA Process AE occurs Patient safety reporting system ie Aims call centre 6262/6464 SAC rating RCA required ? NO No further action required YES Initiate and complete RCA Implement corrective action plan Evaluate

Collect information Gather information already documented Review health records Flow chart/ timeline Get additional information –Site visit –Interviews

Map timeline-chain of events Mary fry chicken in pan Fire start on stove Mary come back – get fire extinguisher Mary leave pan unattended Fire extinguis her does not work Throw water in pan Kitchen burn Fire spread

Causal factor charting Mary fry chicken in pan Fire start on stove Mary come back – get fire extinguisher Mary leave pan unattended Fire extinguis her does not work Electric burner short Oil leak and ignite Melt hole in pan Throw water in pan Kitchen burn Fire spread

Causal factor charting Mary fry chicken in pan Fire start on stove Mary come back – get fire extinguisher Mary leave pan unattended Fire extinguis her does not work Electric burner short Oil leak and ignite Melt hole in pan Throw water in pan Kitchen burn Fire spread CF

Knowing what adverse events occur is only the first step. Most adverse events result from a complex series of behaviours and failures in systems of care. Investigation of the patterns of adverse events requires unearthing the latent conditions and systemic flaws as well as the specific actions that contributed to these outcomes. Dr. G. Ross Baker & Dr. Peter Norton

Swiss cheese model most accidents can be traced to one or more of four levels of failure Organizational influences, unsafe supervision, preconditions for unsafe acts, and the unsafe acts themselves.

In many traditional analyses, the most visible causal factor is given all the attention

Root cause identification Do Root cause mapping of causal factors

Ishikawa diagrams Measurements Personnel Materials EquipmentMethodsEnvironment

Ishikawa diagrams Measurements Personnel Materials EquipmentMethodsEnvironment Callibration Microscopes Inspections Shifts Training OperatorsSuppliers Lubricants Alloys Callibration Speed WearAngle Callibration Humidity Temperature

Causal factor charting Mary fry chicken in pan Fire start on stove Mary come back – get fire extinguisher Mary leave pan unattended Fire extinguis her does not work Electric burner short Oil leak and ignite Melt hole in pan Throw water in pan Kitchen burn Fire spread CF Why did mary leave the pan unattended? Was there a policy regarding phone use in the kichen? Why did she answer the phone Was that policy in use/known to mary?

Causal factor charting Mary fry chicken in pan Fire start on stove Mary come back – get fire extinguisher Mary leave pan unattended Fire extinguis her does not work Electric burner short Oil leak and ignite Melt hole in pan Throw water in pan Kitchen burn Fire spread CF Why did the electric burner short? Is there a replacement policy? Was the burner checked/ serviced? Was the policy adhered to?

Causal factor charting Mary fry chicken in pan Fire start on stove Mary come back – get fire extinguisher Mary leave pan unattended Fire extinguis her does not work Electric burner short Oil leak and ignite Melt hole in pan Throw water in pan Kitchen burn Fire spread CF Why did the fire extinguisher not work? Was Mary trained on the use of Fire extinguisher? Was the fire extinguisher checked/ serviced? Is fire drills done to practice fire emergency procedures?

Causal factor charting Mary fry chicken in pan Fire start on stove Mary come back – get fire extinguisher Mary leave pan unattended Fire extinguis her does not work Electric burner short Oil leak and ignite Melt hole in pan Throw water in pan Kitchen burn Fire spread CF Did Mary know how to extinguish an oil fire? Did whe call for help? Why Not? Was the fire brigade called?

Root cause summary Causal factor # 1Paths Through Root Cause Map Recommendations Mary leaves the frying chicken unattended. Personnel difficulty. Administrative/ management systems. Standards, policies or administrative controls (SPACs) less than adequate (LTA). No SPACs. Implement a policy that hot oil is never left unattended on the stove. Determine whether policies should be developed for other types of hazards in the facility to ensure they are not left unattended. Modify the risk assessment process or procedure development process to address requirements for personnel attendance during process operations.

Root cause summary Causal factor # 2Paths Through Root Cause Map Recommendations Description: Electric burner element fails (shorts out). Equipment difficulty. Equipment reliability program problem. Equipment reliability program design LTA. No program. Replace all burners on stove. Develop a preventive maintenance strategy to periodically replace the burner elements. Consider alternative methods for preparing chicken that may involve fewer hazards, such as baking the chicken or purchasing the finished product from a supplier.

Recommendations List the recommendations Write a report regarding the findings Suggest some implementation strategies

RCA Thoroughness 1. an understanding of how humans interact with their environment; 2. identification of potential problems related to processes and systems; 3. analysis of underlying cause and effect systems through a series of why questions; 4. identification of risks and their potential contributions to the event; 5. development of actions aimed at improving processes and systems; 6. measurement and evaluation of implementation of these actions; and 7. documentation of all steps (from the point of identification to the process of evaluation).

RCA credibility 1. include participation by the leadership of the organization and those most closely involved in the processes and systems; 2. be applied consistently according to organizational policy/procedure; and 3. include consideration of relevant literature.

Root cause analysis techniques Re-enactment ( computer or a simulator) Comparative re-enactment Re-construction-reassembling Barrier analysis Bayesian inference Change analysis - comparing the way an episode did happen with the way it was intended to happen. Current Reality Tree Failure mode and effects analysis Fault tree analysis Five whys Ishikawa diagrams Why-Because analysis Pareto analysis "80/20 rule" RPR Problem Diagnosis - Kepner-Tregoe Approach PROACT Approach Project Management Approaches.

USE of training to reduce errors Training Optimal prevent errorsTraining Too Little inaccuracyTraining Too much Inefficiency

The Institute of Medicine’s Six Elements of Quality 1. Patient safety. Are the risks of injury minimal for patients in the health system? 2. Effectiveness. Is the care provided scientifically sound and neither underused nor overused? 3. Patient centeredness. Is patient care being provided in a way that is respectful and responsive to a patient’s preferences, needs, and values? Are patient values guiding clinical decisions? 4. Timeliness. Are delays and waiting times minimized? 5. Efficiency. Is waste of equipment, supplies, ideas, and energy minimized? 6. Equity. Is care consistent across gender, ethnic, geographic, and socioeconomic lines? Source: Institute of Medicine 2001.

SUMMARY Investigation: The investigation takes place where the event took place. Get sufficient information by: Studying all relevant documents Obtaining reports and/or sworn statements Conducting interviews with complainant/patient/family and staff, as well as supervisors/management Doing observations Brainstorming sessions Determine cause of adverse event Determine whether precautionary and corrective measures are in place Write full report with recommendations to Management and DAEC/PAEC

Disclosure & Rationalisation Disclosure to non-physicians Disclosure to physicians Disclosure to patients Disclosure to facility Rationalisation to cover-up