10-144 C.M.R. ch. 114, § 4 - Root Cause Analysis (RCA)

4.1 Primary Emphasis. The division shall place primary emphasis on ensuring effective corrective action by entities that are subject to these rules. See 22 M.R.S.A. §8755(1).

4.2 RCA Required. The healthcare facility is required to submit to the SET a thorough and credible root cause analysis no later than 45 days after notification of the sentinel event. The RCA may exclude protected professional competence review information pursuant to the Maine Health Security Act.See 22 M.R.S.A. §8753(2).

4.3 RCA Report. The RCA must be submitted in an envelope labeled 'confidential' and the written report must contain at least the following:

4.3.1 Facility-specific unique identifier provided by the SET.

4.3.2 The root cause analysis.

4.3.3 Signature of the chief executive officer (CEO) of the facility.

4.3.4 Other information significant to the identification of systems improvements with the goal being prevention of the recurrence of a similar sentinel event, including but not limited to the following:

4.3.4.1 The final timeline of events.

4.3.4.2 Identification of the occurrence of a similar event or events.

4.3.4.3 Evidence of evaluation of the corrective actions implemented as a result of the similar event or events,

4.3.4.4 Evidence of communication with the receiving facility in the event of an inter-facility transfer.

4.3.4.5 An action plan that includes at least the following:

4.3.4.5.1 Where improvement actions are planned, identification of who is responsible for implementation, when the action will be implemented (including any pilot testing), and how the effectiveness of the action will be evaluated.

4.3.4.5.2 Identification of actions and rationale that clearly and specifically address each proximal cause and contributing factor of the sentinel event.

4.4 Thorough and Credible RCA. An acceptable RCA must comply with the following:

4.4.1 A thorough root cause analysis includes at least the following information:

4.4.1.1 A determination of the human and other factors most directly associated with the sentinel event and the processes and systems related to its occurrence;

4.4.1.2 An analysis of the underlying systems and processes to determine where redesign might reduce risk;

4.4.1.3 An inquiry into all areas appropriate to the specific type of event;

4.4.1.4 An identification of risk points and their potential contributions to the event;

4.4.1.5 A determination of potential improvement in processes or systems that would tend to decrease the likelihood of such an event in the future or a determination, after analysis, that no such improvement opportunities exist;

4.4.1.6 An action plan that identifies changes that can be implemented to reduce risks or formulates a rationale for not undertaking such changes; and,

4.4.1.7 Where improvement actions are planned, an identification of who is responsible for implementation, when the action will be implemented and how the effectiveness of the action will be evaluated.

4.4.2 A credible root cause analysis meets the following criteria:

4.4.2.1 It includes participation by the leadership of the health care facility and by the individuals most closely involved in the processes and systems under review;

4.4.2.2 It is internally consistent (that is, not contradict itself or leave obvious questions unanswered);

4.4.2.3 It provides an explanation for all findings, including those identified as "not applicable" or "no problem," and

4.4.2.4 It includes the consideration of any relevant literature.

4.5 Additional Information. The SET may request additional information regarding the RCA and action plan, and the facility must comply as follows:

4.5.1 The facility must submit its written response to the SET written request for additional information within 14 days of receipt of the request, and the response must be signed by the Chief Executive Officer.

Notes

10-144 C.M.R. ch. 114, § 4