R380-200-4. Causal Analysis

  (1) The incident facility shall establish a causal analysis process.

  (2) The incident facility shall designate a responsible individual to be the facility lead for each patient safety event.

  (3) The incident facility may request the Department representative to participate in the facility's causal analysis in a consultative role to enhance the reliability and thoroughness of the causal analysis.

  (4) The Department shall notify the facility's lead within 72 hours of receiving the patient safety event report whether the Department intends to participate in the facility's root cause analysis.

  (5) Participation in the facility's causal analysis by the Department representative shall not be construed to imply Department endorsement of the facility's final findings or action plan.

  (6) The incident facility and the Department shall each make reasonable accommodations when necessary to allow for the Department representative's participation in the causal analysis.

  (7) If, during the review process, the Department representative discovers problems with the facility's processes that limit either the thoroughness or credibility of the findings or recommendations, the representative shall report these to the designated responsible individual orally within 24 hours of discovery and in writing within 72 hours.

  (8) The facility shall conduct a causal analysis which is timely, thorough and credible to determine whether reasonable system changes would likely prevent a patient safety event in similar circumstances.

  (9) The causal analysis shall:

  (a) focus primarily on systems and processes, not individual performance;

  (b) progress from specific, direct causes in clinical processes to contributing causes in organizational processes;

  (c) seek to determine related and underlying causes for identified causes;

  (d) identify changes which could be made in systems and processes, either through redesign or development of new systems or processes, that would reduce the risk of such events occurring in the future; and

  (e) may include a Known Complication Test Revision set of questions to be utilized when requesting a more thorough response from a unit or physician on evaluation of a known complication related to a procedure, treatment or test. These questions should address:

  (i) Whether the procedure/treatment/test was appropriate and Warranted and based on nationally recognized standards of care;

  (ii) Whether the complication is a known risk, was anticipated before the procedure and that the standard of care applied to mitigate the risk;

  (iii) Whether the complication was identified in a timely manner (i.e. at the time of the occurrence);

  (iv) Whether the complication treatment was according to the standard of care and in a timely manner; and

  (v) Whether the treatment of the complication follows a nationally recognized standard of care.

  (10) The Department shall determine the causal analysis to be complete if it:

  (a) involves a complete review of the patient safety event including interviews with all readily identifiable witnesses and participants and a review of all related documentation;

  (b) identifies the human and other factors in the chain of events leading to the final patient safety event, and the process and system limitations related to the occurrence;

  (c) searches readily retrievable records to analyze the underlying systems and processes to determine where redesign might reduce risk;

  (d) makes reasonable attempts to identify and analyze trends of similar events which have occurred at the facility in the past;

  (e) identifies risk points and their potential contributions to this type of event;

  (f) determines potential improvement in processes or systems that would tend to decrease the likelihood of such events in the future, or that no such improvement opportunities exist; and

  (g) is based on the evidence from the research literature, data from other sources, or is derived from a formal organizational improvement strategy.

  (11) The Department shall determine the causal analysis to be credible if it:

  (a) is led by someone with training in causal analysis processes and who was not involved in the patient safety event;

  (b) involves any necessary consultation with either internal or external experts in the processes in question who were not involved in the patient safety event;

  (c) includes participation by the leadership of the organization;

  (d) includes individuals most closely involved in the processes and systems under review;

  (d) is internally consistent, does not contradicting itself or leave obvious questions unanswered;

  (e) provides an explanation for all findings of "not applicable" or "no problem"; and

  (f) includes consideration of relevant, available literature.