The purpose of this rule is to establish standards and procedures to ensure that prompt and accurate reporting, immediate evaluation, implementation of corrective/remedial action, and preventive measures take place with the occurrence of each incident. Effective incident reporting provides each hospital with individual and cumulative incident report data to find problem areas and to implement corrective measures designed to prevent recurrence and manage risk. Analysis of this data can reveal systems issues and problems in need of corrective action.
The provisions of this rule shall be applicable to all hospital inpatient and community support network (CSN) programs under the managing responsibility of the department.
The following definitions shall apply to this rule in addition to those appearing in rule 5122-1-01 of the Administrative Code:
(1) "Abuse" means any act or absence of action caused by an employee inconsistent with rights which results, or could result in physical injury to a patient; any act which constitutes sexual activity, as defined under Chapter 2907. of the Revised Code, where such activity would constitute an offense against a patient under that chapter; insulting or coarse language or gestures directed toward a patient which subjects the patient to humiliation or degradation; or depriving a patient of real or personal property by fraudulent or illegal means.
(2) "Chief clinical officer" or "CCO" means the medical director of a hospital.
(3) "Chief executive officer" or "CEO" means an individual who is the managing officer of the hospital operated by the department of mental health.
(4) "Confirmed abuse/neglect" means the abuse/neglect has been proven to have occurred.
(5) "Critical major incident" means those events for which there is a need to immediately advise the deputy director of hospital services, and ODMH director of the situation.
(6) "Fire", for qualification as a major incident, means any fire that results in an injury and/or that a fire department responded to and extinguished and/or that caused the evacuation of a building.
(7) "Incident" means any occurrence which is not consistent with the routine care of a patient; the routine services provided by the hospital; or the routine standard of care for the hospital. Incidents include accidents, unusual occurrences, or situations which might result in injury to a person or damage to property or equipment. Incidents may involve patients, employees, visitors, and other persons.
Incidents involving patients are not restricted to those occurrences on the hospital's premises. Also included is any patient who is on the rolls of the hospital and is involved in an incident while away from the hospital.
(8) "Major incident" means an occurrence severe enough to warrant special categorization for purposes of reporting.
(9) "Minor incident" means those types of occurrences which do not appear to be severe or detrimental to the best interests of the patient, department, hospital, or personnel.
(10) "Neglect" means a purposeful or negligent disregard of duty imposed on an employee by statute, rule, hospital policy, position description, or professional standard and owed to a client by that employee.
(11) "Office of quality assurance/improvement" means the office of quality assurance/improvement of ODMH.
(12) "Patient care system" or "PCS" means the official secure centralized ODMH automated database where patient demographic and related information is maintained.
(13) "Program" means any services provided by the ODMH employees.
(14) "Sentinel event" means those events as defined in rule 5122-2-25 of the Administrative Code.
(15) "Unfounded abuse/neglect" means it was proven that the abuse/neglect did not occur.
(16) "Unproven abuse/neglect" means it could not be proved that the incident happened or did not happen. There may have been conflicting or inadequate evidence to either prove or disprove that the abuse/neglect occurred.
(D) Reporting of incidents
(1) All incidents shall be documented and reported in accordance with the provisions of this rule and on the forms and database prescribed by the department.
(2) Investigation of incidents
(a) The CEO shall develop an investigative procedure to be followed by employees in response to the occurrence of all incidents.
(b) Based on the severity of the occurrence, some incidents are considered as major or critical and shall be reported to central office.
(3) Incidents classified as major
(a) Major incidents shall include, but not be limited to, the following:
(i) All sentinel events.
(ii) All deaths. In addition, the following deaths shall be reported immediately to the coroner and the Ohio state highway patrol:
(b) Accidental death regardless of cause;
(c) Apparent or possible homicide; and
(d) Any suspicious or unusual death .
(iii) All allegations of abuse and/or neglect.
(iv) Events determined by the CEO or designee and/or CCO or designee that require the immediate investigation by the local law enforcement agency and/or the Ohio state highway patrol. Examples of these are:
(a) Serious injury caused by another person, whether another patient, employee, or any other person;
(b) Alleged criminal act of an employee committed on hospital grounds or while performing occupational duties off grounds which may result in a felony or misdemeanor charge;
(c) Alleged criminal act of a patient which may result in a felony or misdemeanor charge;
(d) Alleged criminal act on hospital grounds by person other than an employee or patient which may result in a felony or misdemeanor charge; and,
(e) The absence without leave (AWOL) of a forensic patient, as defined in ODMH policy MF-02, "AWOL Reporting" or its replacement, or any patient determined to be dangerous.
(v) Events primarily related to medical and/or nursing practice requiring immediate evaluation/investigation as determined by the CEO or designee, the CCO or designee, or the director of nursing or designee. Examples of these incidents are:
(a) The attempted suicide or any action of self-injurious behavior by a patient considered serious in nature;
(b) An accidental injury of a person considered to be serious that was not caused by the direct action or inaction of another person;
(c) The adverse drug reaction of a patient to a life threatening degree;
(d) A medication error that results in serious consequences;
(e) A medical emergency that was serious or life threatening; and
(f) The unauthorized use of restraint/seclusion or locked time-out.
(vi) Property damage or loss resulting in replacement/repair cost of more than one thousand dollars;
(vii) Fires, as previously defined;
(viii) Bomb threats or other threats made, written, or telephoned considered to be major in consequence as determined by the CEO or designee; and
(ix) Any serious situation disrupting the normal operation, safety, and/or security of the hospital or facility, patients, and/or staff, such as the malfunction, damage, or unscheduled loss of mechanical systems, floods, or severe weather conditions.
(b) Based upon evaluation of available facts and consultation with staff, the CEO or designee shall be responsible for making the final determination as to whether an incident shall be classified as a major incident, except for those incidents mentioned in paragraphs (D)(3)(a)(i) to (D)(3)(a)(iii) of this rule, and suicide attempts, which are always major incidents. If the facts are unusual, or when in doubt, the CEO or designee shall handle the incident as a major incident.
(4) Minor incidents include those types of occurrences which do not appear to be severe or detrimental to the best interests of the patient, department, hospital facility, or personnel.
(a) The employee who discovers or witnesses an incident, or to whom an incident is reported, is responsible for documenting the incident, cooperating in the investigation, and providing the investigating officer/staff with a complete statement or statements as needed.
(b) The incident notification report (DMH-ADM-005a or DMH-CSN-008, as appropriate) required by ODMH shall be completed for each incident. Each CSN also has additional reporting responsibilities as described in paragraph (D)(7)(c) of this rule, utilizing form DMH-0484/LIC-015.
(c) Facts regarding the incident shall be reported in writing. No unsubstantiated conclusions, opinions, hearsay, assumptions, or accusations shall be included in the incident report.
(d) The incident report shall not be filed, nor references to an incident report made, in the patient medical record. The incident report shall be maintained in an administrative file. The CEO shall utilize a procedure for the filing and internal management of incident reports.
(e) The fact that an incident report has been completed shall not be documented in the patient medical record. However, those events which have a direct medical/clinical effect on the patient should be recorded in the patient medical record, but with no mention of completion of an incident report.
(f) The hospital shall develop policies regarding the copying of incident report materials.
(g) Incident reports shall be maintained in a confidential manner and be accessible only to authorized employees except by consent of the CEO, or the order of a judge of a court of law.
(h) The Ohio state highway patrol may have access only to the incident notification report form (DMH-ADM-005a) or the CSN incident notification report form (DMH-CSN-008) should it make such a request.
(i) The CEO shall designate a person to be responsible for notifying the parents/spouse, legal guardian, or legal custodian of a patient about the occurrence of an incident involving a patient. This disclosure shall require the consent of the patient except if the patient is deceased, AWOL, or unconscious.
(j) The CEO shall develop a policy that determines which hospital staff are to be notified of the occurrence of incidents.
(k) If requested by the local mental health board, the mental health board shall have access to only the information on the incident notification report form (DMH-ADM-005a) or the CSN incident notification report form (DMH-CSN-008).
(6) Immediate telephone reporting to central office
(a) Utilizing the telephone call-in procedure, the CEO or designee shall report at all times, the occurrence of any of the following major incidents to the deputy director of hospital services.
(i) All deaths;
(ii) AWOL of a forensic patient as defined in the ODMH policy MF-02, "AWOL Reporting" or its replacement, or dangerous patient, or a patient whose medical condition or nursing/medical needs are such that his/her AWOL status might be life-threatening or the weather conditions are such that the patient's life may be in danger;
(iii) Fires, as previously defined in paragraph (C)(7) of this rule;
(iv) Equipment malfunction, damage, or unscheduled loss of mechanical systems that may result in significant potential danger as determined by the CEO or designee to staff and/or patients (for example: loss of fire alarm/suppression systems, telephone service, emergency generator, or water/sanitary systems);
(v) Other incidents that the CEO or designee determines are critical in nature that may result in significant danger to staff and/or patients (for example: a hostage situation, a flood, severe weather conditions, bizarre or unusual crimes or events); and,
(vi) Any incident as determined by the CEO or designee that would likely result in news media coverage.
(b) All incidents that involve a morbidity, mortality, or reviewable sentinel event, as defined in rule 5122-2-25 of the Administrative Code,"Morbidity, mortality, and sentinel event", shall be reported to the ODMH medical director or designee by the hospital CCO or designee via telephone or email.
(c) For critical major incidents occurring five p.m. to eight a.m. Monday through Friday and all day on weekends and holidays the CEO or designee, shall contact the ODMH deputy director of hospital services (refer to ODMH policy I-05 or its replacement).
(7) Other procedures for reporting to central office
(a) All incidents involving a morbidity, mortality, or sentinel event shall be reviewed and reported to the hospital services morbidity and mortality committee as specified by rule 5122-2-25 of the Administrative Code,"Morbidity, mortality, and sentinel event".
(b) For inpatient programs, all major incidents, including those mentioned in paragraph (D)(6) of this rule, shall be reported to the ODMH office of quality assurance/improvement in central office within twenty-four hours of the incident using the automated PCS incident notification report system.
(c) For CSN programs, all major incidents must be reported to the ODMH office of quality assurance/improvement in central office within twenty-four hours of learning of the incident, using form DMH-CSN-008.
In addition, the CSN, including its licensed residential facilities, shall report outpatient services incidents in accordance with rule 5122-26-13 of the Administrative Code and report residential facility incidents in accordance with rule 5122-30-16 of the Administrative Code. These reports shall be made using form DMH-0484/LIC-015.
(d) The ODMH office of quality assurance/improvement may require such other reports/documents as are necessary to conclude a review of any incident (major critical or minor). Data regarding all incidents shall be maintained in a form specified by central office.
(e) Data regarding minor incidents shall be maintained in a form specified by central office using the automated PCS incident notification report system.
(E) Individual and aggregate analysis
(1) Each hospital and CSN program shall ensure that all incidents are thoroughly and comprehensively reviewed and analyzed:
(a) At the time of submission, on an individual basis, for adequacy of documentation and to effect necessary follow-up; and,
(b) At regular intervals and yearly, on an aggregate basis, to determine trends or patterns indicative of a need for corrective action.
(c) Data shall be made available to the ODMH office of quality assurance/improvement.
(2) At regular intervals, the ODMH office of quality assurance/improvement shall supply hospitals/facilities with aggregate data on incidents.
(F) Implementation of incident reporting
The CEO of each hospital shall be responsible for prescribing guidelines for implementation of this rule.
Promulgated Under: 111.15
Statutory Authority: 5119.01, 5119.07, 5119.27, 5119.43, 5119.82
Rule Amplifies: 5119.01
Prior Effective Dates: 7-27-1979, 7-1-1980, 2-5-1982, 2-1-2000, 7-15-2002