5122-2-25 Morbidity, mortality, and sentinel events.

(A) Purpose:

(1) To define and establish investigation and reporting mechanisms for both morbidity and mortality events, and sentinel events.

(2) Morbidity, mortality, and sentinel events consist of the following situations:

(a) Death or major permanent loss of function of a patient currently receiving services at an ODMH regional psychiatric hospital (RPH) or community support network (CSN) program:

(b) Death of a former patient within thirty days of discharge from an RPH:

(c) Suicide attempt by a current RPH or CSN patient or within thirty days of discharge from an RPH:

(d) Any serious patient injury or condition that probably resulted from clinical care of lack of clinical care:

(e) Abduction of a patient receiving care, treatment, and services:

(f) Alleged rape of a patient while being treated or on the premises of the RPH or CSN. under the following conditions: staff-witnessed sexual contact: sufficient clinical evidence obtained by the RPH to support allegations of nonconsensual sexual contact: or admission by the perpetrator that sexual contact occurred on the premises.

(B) Definitions shall apply to this rule in addition to or in place of those appearing in rule 5122-1-02 of the Administrative Code:

(1) "Intense analysis" means a performance improvement process used to examine systems and processes in order to identify improvements and risk reduction strategies to prevent morbidity, mortality, and sentinel events. This process shall be used to review morbidity, mortality, sentinel events, and near miss events that do not meet the criteria for a full root cause analysis.

(2) "Morbidity and mortality alert" (M&M alert) means a communication from the ODMH medical director/designee to RPH chief executive officers (CEOs), chief clinical officers (CCOs). clinical nurse managers, and quality improvement directors for the purpose of recommending initial and/or safety actions to minimize risk to patients in all ODMH RPHs and CSNs.

(3) "Morbidity/mortality event" (M&M event) means any type of death (mortality! or situation where, except for the presence of appropriate and effective medical/psychiatric care, the patient would have died (morbidity). :

Morbidity/mortality events include

(a) Death or major permanent loss of function of a patient currently receiving services at an ODMH RPH or CSN:

(b) Death of a former patient within thirty days of discharge from an RPH;

(c) Suicide attempt by a current RPH or CSN patient, or within thirty days of discharge from an RPH;

(d) Any serious patient injury or condition hat probably resulted from clinical care or lack of clinical care.

(4) "Reviewable sentinel event" means the subset of sentinel events that falls within the scope of the joint commission's sentinel event policy and is subject to review by the joint commission. This includes any occurrence that meets the following criteria:

(a) Any event that results in an unanticipated death or major permanent loss of function, not related to the natural cause of a patient's illness or underlying condition (e.g.. a medication error, assault, fall, restraint, or elopement resulting in death or major permanent loss of function);

(b) Suicide of a patient receiving care, treatment, and services in a staffed around-the-clock care setting or within seventy-two hours of discharge;

(c) Abduction of a patient receiving care, treatment, and services;

(d) Alleged rape of a patient while being treated or on the premises of the RPH or CSN. under the following conditions: staff-witnessed sexual contact; sufficient clinical evidence obtained by the hospital to support allegations of nonconsensual sexual contact; or admission by the perpetrator that sexual contact occurred on the premises.

(5) "Root cause analysis" means a process for identifying the basic or causal factors that underlie variation in performance, including the occurrence or possible occurrence of a sentinel event. A root cause analysis focuses primarily on systems and processes, not on individual performance. It progresses from special causes in clinical processes to common causes in organizational processes and systems, and identifies potential improvements in processes or systems that would tend to decrease the likelihood of such events in the future or determines, after analysis, that no such improvement opportunities exist.

(6) "Sentinel event" means an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or limb function. The phrase "or the risk thereof includes any "near miss" or process variation for which a recurrence would carry a significant chance of a serious adverse outcome.

(C) Policy

(1) ODMH hospital services (HS) morbidity and mortality quality assurance committee (HSM&M committee):

(a) Membership shall consist of the following individuals:

(i) Chair - ODMH medical director/designee;

(ii) ODMH quality assurance/improvement director;

(iii) ODMH clinical safety director within the division of the medical director;

(iv) ODMH chief legal counsel/designee;

(v) ODMH deputy director of HS/designee; and

(vi) Others, as deemed appropriate.

(b) The ODMH HSM&M committee shall serve the following functions:

(i) Review all hospital morbidity, mortality, and reviewable sentinel event reports for completeness;

(ii) Determine whether appropriate policies and procedures were followed in the filing of hospital morbidity, mortality, and reviewable sentinel event reports;

(iii) Determine if any form of in-service education should occur;

(iv) Recommend methods to reduce future incidents to ODMH RPHs statewide through M&M alerts and other mechanisms, as developed;

(v) Develop, review, and revise as needed, the department administrative rule on morbidity, mortality, and sentinel events;

(vi) Determine if a specialized review process or subcommittee should be established to review individual events; and.

(vii) Analyze (i) through (vi) of this paragraph (C)(1)(b) and develop annual reports regarding morbidity, mortality and reviewable sentinel events including trends or patterns of performance.

(c) The committee shall meet at least quarterly;

(d) Meeting minutes and summary reports, as deemed appropriate, will be developed and maintained by the quality improvement director.

(2) Regional psychiatric hospital morbidity and mortality quality assurance committee (RPH M&committee).

(a) Each RPH shall establish an M&M committee/subcommittee under the medical executive committee. The committee shall function as part of the hospital's quality assurance program. The hospital CCO or designee shall chair the committee.

(b) The members of the RPH M&M committee shall be appointed by the hospital CEO and shall consist of at least the following members:

(i) Chair - RPH CCO/physician designee;

(ii) RPH quality assurance/improvement (QA/QI) director;

(iii) RPH risk manager/safety officer/patient safety coordinator/designee;

(iv) RPH nurse executive or registered nurse designee;

(v) RPH CEO or designee from administration; and

(vi) Other RPH staff as needed, depending on the circumstances surrounding the case or because of involvement with the patient's treatment regime (e.g., security department, staff/supervisors, physician, nurse, client advocate, risk manager, pharmacist, medical records administrator, CSN program director/supervisor/staff, etc.).

(c) The RPH M&M committee shall review each morbidity, mortality and reviewable sentinel event as described in section (A)(2) of this rule and document the review on forms maintained securely by the hospital QA/QI director.

(d) Meetings shall be called by the chair of the committee at least quarterly. or as needed. The minutes of the RPH M&M committee meetings shall be maintained securely by the hospital's OA/OI director. Names and titles of all staff present shall be indicated, as well as the date and time of the meeting. If a staff member is representing another staff person, this shall be indicated in the minutes. A copy of the minutes may be requested by the office of quality assurance/improvement in central office.

(3) All proceedings, records, information, data, reports, recommendations, evaluations, opinions, and findings of the hospital and central office morbidity, mortality, and sentinel events reviews are strictly confidential and are not subject to disclosure or discovery or introduction in evidence in any civil action, as specified in sections 1751.21 . 2305.24 . 2305.25 . 2305.251 . 2305.252 . 2305.253 . 2305.28 . 5122.31 . and 5122.32 of the Ohio Revised Code.

(D) Procedure

(1) Review and reporting process (see appendix A: flow chart of the morbidity, mortality, and sentinel event review procedure).

(a) Notification:

Immediately following a morbidity, mortality or sentinel event that meets the criteria defined under (A)(2)(a) through (A)(2)(f) of this rule, the hospital CEO/designee shall report the event to the ODMH hospital services (HS) deputy director/designee via phone or e-mail, and the hospital CCO/designee shall report the event to the ODMH medical director/designee via phone or e-mail. The RPH shall attempt to report the event to the patient and guardian, and shall attempt to notify the patient's family, if the patient has provided consent.

(b) Initial review bv RPH M&M:

An initial review shall be completed by the CCO/designee and at least two other hospital M&M committee members using the ODMH morbidity, mortality and sentinel event report form, section I (appendix B). The initial review shall be submitted to the HSM&M committee by noon of the second business day following the event or discovery of the event.

The purpose of the initial review is (1) to review events and circumstances preceding the event; (2) to identify immediate action needed to reduce risk of a similar event occurring in the immediate future; (3) select the appropriate level of analysis to complete a full review (intense analysis or root cause analysis); and (4) to determine information to be gathered to complete the full review.

The HSM&M committee designees shall review the description of actions provided by the hospital CCO and may issue an M&M initial alert to all RPHs.

(c) Full review bv RPH M&M:

The hospital CEO/CCO/designee shall determine whether the event is a reviewable sentinel event, morbidity/mortality event, or other sentinel event.

(i) For reviewable sentinel events, a thorough and credible root cause analysis shall be conducted by the RPH M&M committee and submitted to the HSM&M committee within forty-five days of the event or its discovery using the ODMH morbidity, mortality, and sentinel event report form.

The deputy director of HS/ODMH medical director/designee shall determine whether to report the event as a sentinel event to the joint commission; or as a restraint-related death to CMS.

(ii) For morbidity and mortality events that do not meet criteria described in (B)(5) of this rule, an intense analysis shall be conducted and submitted to the HSM&M committee within thirty days of the event or its discovery using the ODMH morbidity, mortality, and sentinel event report form, or the CCO/CEO may direct the completion of a root cause analysis.

At least one root cause analysis of a morbidity, mortality, or sentinel event must be conducted annually.

(iii) For all other sentinel events not described in (D)(1)(C)(i) or (D)(1)(c)(ii) of this rule, a criminal and/or administrative investigation shall occur in accordance with RPH internal policy.

The RPH M&M committee may assign parts of the investigation to quality assurance subcommittees which include staff at all levels closest to the issue(s) and those with decision-making authority.

It is understood that care provided outside of the RPH. (e.g.. general hospital care, group home, own home, etc.l may not be accessible to the RPH for review.

(d) Review upon receipt of death certificate, and coroner's report (if available).

If the event is a death, a death certificate and coroner's report (if available) shall be reviewed, and its impact, if any, on the findings of the RPH M&M committee shall be noted on the ODMH morbidity, mortality, and sentinel event report form, section IV. If the coroner's report is not available at the time of the full review, a follow-up review by the RPH M&M committee is to be completed within seven days of the receipt of the coroner's report. An amended root cause analysis or intense analysis form shall be completed as indicated.

(e) Status of risk reduction plan.

Progress on each risk reduction strategy identified in the full review shall be reported on a quarterly basis using the ODMH morbidity, mortality, and sentinel event report form, section VI. A status report is due within thirty days of the end of each quarter, until the intervention plan is complete.

(2) Reports.

(a) The initial review shall be completed and submitted to the HSM&M committee using the ODMH morbidity, mortality, and sentinel event report form, section I. by noon of the second business day following the event or discovery of the event.

If an intense analysis is required, it shall be completed and submitted to the HSM&M committee using the ODMH morbidity, mortality, and sentinel event report form, section III, within thirty days of the event or discovery of the event.

If a root cause analysis is required, it shall be completed and submitted to the HSM&M committee using the ODMH morbidity, mortality, and sentinel event report form, section III and IV. within forty-five days of the event or discovery of the event. A copy of the death certificate and coroner's report (if available^) and an amended intense analysis or root cause analysis form shall be submitted within seven days after it is received by the RPH.

Status reports are due within thirty days of the end of each quarter using the ODMH morbidity, mortality, and sentinel event report form, section VI. until the intervention plan is complete.

(b) The ODMH HSM&M committee shall review all reports submitted, and may request that the RPH further refine the analysis. Based on the findings of the full review, the ODMH HSM&M committee may issue an M&M safety alert to other RPHs to communicate recommendations for patient safety, system improvement, and risk management.

(3) Quality assurance review at the RPH and HS system levels.

(a) The RPH quality assurance and/or risk management committees shall review hospital morbidity, mortality, and sentinel event reports on a regular basis in order to evaluate the effectiveness of the improvements made in the system, and further refine the system as indicated.

(b) The ODMH HSM&M committee shall conduct analyses of quality assurance reports to assure overall system improvements are implemented, that implementation is evaluated, and that training needs are incorporated into educational planning for the hospitals.

(c) An annual report concerning morbidity, mortality, and sentinel events shall be submitted to the ODMH director bv the ODMH HSM&M committee.

Replaces: 5122-2-25

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Effective: 03/15/2010
Promulgated Under: 111.15
Statutory Authority: 5119.01
Rule Amplifies: 5119.01
Prior Effective Dates: 1-1-1996, 9-24-1998, 12-1-2000, 6-2-2003