Ohio Administrative Code › Title 5160 - Ohio Department of Medicaid › Chapter 5160-45 - Administered Waiver Service Providers › Section 5160-45-05 - Ohio department of medicaid (ODM) -administered waiver program: incident management system

Current through all regulations passed and filed through July 1, 2024
(A) For the purposes of this
				rule,
(1) "Alert" means an incident that must
				be reported to the Ohio department of medicaid (ODM) due to the severity and/or
				impact on an individual enrolled on an ODM-administered waiver or the need for
				ODM involvement in the incident investigation. Alerts include, but are not
				limited to the events described in paragraph (J) of this rule.
(2) "Incident" means an alleged,
				suspected or actual event that is not consistent with the routine care of,
				and/or service delivery to, an individual. Incidents include, but are not
				limited to the events described in paragraph (F) of this rule.
(3) "Individual" means a person who is
				enrolled in an ODM-administered waiver or who participates in any
				ODM-administered program that is directed to adhere to this rule.
(4) "Provider" means an
				ODM-administered waiver service provider, any other service provider that is
				directed to adhere to this rule, and all of their respective staff who have
				direct contact with individuals.
(B) ODM shall operate an incident
				management system that includes responsibilities for reporting, responding to,
				investigating and remediating incidents. This rule sets forth the standards and
				procedures for operating that system. It applies to ODM, its designees,
				individuals and providers. ODM may designate other agencies or entities to
				perform one or more of the incident management functions set forth in this
				rule.
(C) ODM and its designees shall assure
				the health and welfare of individuals enrolled on an ODM-administered waiver.
				ODM, its designees and providers are responsible for ensuring individuals are
				protected from abuse, neglect, exploitation and other threats to their health,
				safety and well-being.
(D) Upon entering into a medicaid
				provider agreement, and annually thereafter, all providers, including all
				employees who have direct contact with individuals enrolled on an
				ODM-administered waiver, must acknowledge in writing they have reviewed this
				rule and related procedures.
(E) Upon an individual's enrollment in
				an ODM-administered waiver, and at the time of each annual reassessment, ODM or
				the designated case management contractor shall provide the individual and/or
				the individual's authorized representative or legal guardian with a waiver
				handbook that includes information about how to report abuse, neglect,
				exploitation and other incidents. The case management contractor shall secure
				from the individual, authorized representative and/or legal guardian written
				confirmation of receipt of the handbook and it shall be maintained in the
				individual's case record.
(F) Incidents include, but are not
				limited to, all of the following:
(1) Abuse: the injury, confinement,
				control, intimidation or punishment of an individual by another person that has
				resulted, or could reasonably be expected to result, in physical harm, pain,
				fear or mental anguish. Abuse includes, but is not limited to physical,
				emotional, verbal and/or sexual abuse, and use of restraint, seclusion or
				restrictive intervention that results in, or could reasonably be expected to
				result in, physical harm, pain, fear or mental anguish to the
				individual.
(2) Neglect: when there is a duty to do
				so, the failure to provide goods, services and/or treatment necessary to assure
				the health and welfare of an individual.
(3) Exploitation: the unlawful or
				improper act of using an individual or an individual's resources for monetary
				or personal benefit, profit or gain.
(4) Misappropriation: depriving,
				defrauding or otherwise obtaining the money, or real or personal property
				(including medication) of an individual by any means prohibited by
				law.
(5) Death of an
				individual.
(6) Hospitalization or emergency
				department visit (including observation) as a result of:
(a) Accident, injury or
				fall;
(b) Injury or illness of an unknown
				cause or origin; and
(c) Reoccurrence of an illness or
				medical condition within seven calendar days of the individual's discharge from
				a hospital.
(7) Unauthorized use of restraint,
				seclusion and/or restrictive intervention that does not result in, or cannot
				reasonably be expected to result in, injury to the individual.
(8) An unexpected crisis in the
				individual's family or environment that results in an inability to assure the
				individual's health and welfare in his or her primary place of
				residence.
(9) Inappropriate service delivery
				including, but not limited to:
(a) A provider's violation of the
				conditions of participation set forth in rule
				5160-45-10
				of the Administrative Code;
(b) Services provided to the individual
				that are beyond the provider's scope of practice;
(c) Services delivered to the
				individual without, or not in accordance with, physician's orders;
				and
(d) Medication administration errors
				involving the individual.
(10) Actions on the part of the
				individual that place the health and welfare of the individual or others at
				risk including, but not limited to:
(a) The individual cannot be
				located;
(b) Activities that involve law
				enforcement;
(c) Misuse of medications;
				and
(d) Use of illegal
				substances.
(G) Incident reporter
				responsibilities.
(1) ODM, its designees and all
				providers are required to report incidents in accordance with the procedures
				set forth in this rule.
(2) Individuals and/or their authorized
				representative or legal guardian should report incidents to the individual's
				case manager and the appropriate authorities.
(3) If a person or an entity identified
				in paragraph (G)(1) of this rule learns of an incident, the person or entity
				shall do all of the following:
(a) Take immediate action to assure the
				health and welfare of the individual which may include, but is not limited to,
				seeking or providing medical attention.
(b) Immediately report the incident(s)
				set forth in paragraphs (F)(1) to (F)(5) of this rule to the case manager and
				the appropriate authories set forth in paragraph (G)(5)(a) of this
				rule.
(c) Report any incidents set forth in
				paragraphs (F)(6) to (F)(10) of this rule to the case manager within
				twenty-four hours unless bound by federal, state or local law or professional
				licensure or certification requirements to report sooner.
(4) At a minimum, all incident reports
				shall include:
(a) The facts that are relevant to the
				incident;
(b) The incident type; and
(c) The names of, and when available,
				the contact information for, all persons involved.
(5) The appropriate authority is
				dependent upon the nature of the incident. Examples of appropriate authorities
				include, but are not limited to:
(a) The following agencies that hold
				investigative and/or protective authority:
(i) Local law enforcement if the
				incident involves conduct that constitutes a possible criminal act including
				but not limited to, abuse, neglect, exploitation, misappropriation or death of
				the individual;
(ii) The local coroner's
				office;
(iii) The local county board of
				developmental disabilities (CBDD);
(iv) The local public children services
				agency (PCSA); and
(v) The local public adult protective
				services agency.
(b) The following regulatory, oversight
				and/or advocacy agencies:
(i) The Ohio long term care
				ombudsman;
(ii) The alcohol, drug addiction and
				mental health service board;
(iii) The Ohio department of health
				(ODH), or other licensure or certification board or accreditation body when the
				allegation involves a provider regulated by that entity;
(iv) The Ohio attorney general when the
				allegation is suspected to involve medicaid fraud by the provider;
				and
(v) The local probate court when the
				allegation is suspected to involve the legal guardian.
(6) The incident reporter must also
				notify his or her supervisor if he or she has one.
(H) Case management contractor
				responsibilities.
(1) The case management contractor
				shall do all of the following upon discovery of an incident:
(a) Ensure that immediate action was
				taken to protect the health and welfare of the individual and any other
				individuals who may be at-risk.
(b) Notify the appropriate agencies
				that hold investigative and/or protective authority as set forth in paragraph
				(G)(5)(a) of this rule if the incident was one of those set forth in paragraph
				(F)(1) to (F)(5) of this rule.
(c) Notify the appropriate additional
				regulatory, oversight and/or advocacy agencies set forth in paragraph (G)(5)(b)
				of this rule.
(d) Notify the individual's lead
				physician.
(2) Complete an incident report in
				ODM's electronic case management system within twenty-four hours of
				discovery.
(3) The case management contractor
				shall notify ODM within twenty-four hours of any incident that meets the
				criteria of an alert as set forth in paragraph (J) of this rule.
(4) The case management contractor
				shall notify the individual and/or the individual's authorized representative
				or legal guardian as long as such notification will not jeopardize the incident
				investigation and/or place the health and welfare of the individual or reporter
				at risk.
(I) Provider oversight
				responsibilities.
(1) ODM or its designated provider
				oversight contractor must review all reported incidents within one business day
				of notification via ODM's electronic case management system, and shall do all
				of the following as part of its review:
(a) Verify that immediate action was
				taken to protect the health and welfare of the individual and any other
				individuals who may be at-risk. If such action was not taken, the provider
				oversight contractor must do so immediately.
(b) Verify that the county coroner was
				notified in the event of the death of an individual. If such action was not
				taken, the provider oversight contractor must do so immediately.
(c) Verify that the appropriate
				authorities have been notified as required by this rule. If such action was not
				taken, the provider oversight contractor must do so immediately.
(d) Verify that the incident was
				reported within the timeframe required by this rule.
(e) Notify ODM of any incident that
				meets the criteria of an alert as set forth in paragraph (J) of this
				rule.
(2) The provider oversight contractor
				shall initiate an investigation no later than two business days after having
				been notified of an incident. At a minimum, the provider oversight contractor
				shall:
(a) Contact and work cooperatively with
				protective agencies and any other entities to whom the incident was reported
				and that may be conducting a separate investigation.
(b) Conduct a review of all relevant
				documents including, but not limited to, all services plans, assessments,
				clinical notes, communication notes, coroner's reports, documentation available
				from other authorities, provider documentation, plans of care, provider billing
				records, medical reports, police and fire department reports and emergency
				response system reports.
(c) Conduct and document interviews
				with anyone who may have information relevant to the incident investigation
				including, but not limited to, the reporter, individuals, authorized
				representatives and/or legal guardians and providers.
(d) Include the individual and the
				reporter in the incident investigation process, as long as such involvement is
				both safe and appropriate.
(e) When applicable, make referrals to
				appropriate licensure or certification boards, accreditation bodies, and/or
				other entities based on the information obtained during the
				investigation.
(f) Document all investigative
				activities.
(g) Document if and why any of the
				steps set forth in paragraph (I) of this rule were omitted from the incident
				investigation.
(3) If, at any time during the
				investigation of a death, it is determined the incident meets the criteria for
				a suspicious death as described in paragraph (J)(2)(a) of this rule, or the
				death may have been preventable, the provider oversight contractor must notify
				ODM within twenty-four hours of the contractor's discovery. If ODM agrees the
				death is suspicious in nature or was preventable, it shall maintain lead
				responsibility for the investigation and follow all of the steps set forth in
				paragraph (I) of this rule and the ODM-approved death investigation protocol.
				All other deaths shall be investigated by the provider oversight contractor in
				accordance with the steps set forth in paragraph (I) of this rule and the
				ODM-approved death investigation protocol.
(4) Concluding an incident
				investigation.
(a) The provider oversight contractor
				must conclude its incident investigation no later than forty-five days after
				the provider oversight contractor's initial receipt of the incident report.
				Extension of this deadline is only permissible upon prior approval by
				ODM.
(b) At the conclusion of the
				investigation, the provider oversight contractor shall:
(i) Submit to ODM and the individual,
				authorized representative and/or legal guardian a written report
				that:
(a)
				Summarizes the investigation;
(b)
				Identifies if the incident was substantiated and whether it was preventable;
				and
(c)
								Includes a prevention plan for the individual that
				identifies the steps necessary to mitigate the effects of a substantiated
				incident, eliminate the causes and contributing factors that resulted in risk
				to the health and welfare of the individual and any other persons impacted by
				the incident and prevent future incidents.
(ii) Notify ODM-administered waiver
				service providers who are subject to the incident investigation in writing upon
				substantiation of an incident. The notification shall specify:
(a) The
				findings of the investigation that substantiate the occurrence of the
				incident;
(b) The
				Administrative Code rule(s) that support(s) the finding(s) of the
				investigation;
(c) What
				steps the provider must take in order to mitigate against the causes of and
				factors contributing to the incident; and
(d)
								The
				timeframe within which the provider must submit a plan of correction to the
				provider oversight contractor in accordance with rule
				5160-45-06
				of the Administrative Code, not to exceed fifteen calendar days after the date
				the letter was mailed.
(iii) Provide a written summary of the
				investigative findings to the reporter of the incident unless such action could
				jeopardize the health and welfare of the individual.
(iv) Assure that all such reports
				issued pursuant to paragraph (I)(4) of this rule shall comply with all
				applicable state and federal confidentiality and information disclosure
				laws.
(J) Alerts.
(1) The provider oversight contractor
				shall ensure that incidents that rise to the level of an alert are reported to
				ODM within twenty-four hours of the incident's identification and report
				submission.
(2) The following incidents are cause
				for an alert:
(a) A suspicious death in which the
				circumstances and/or the cause of death are not related to any known medical
				condition, and/or; in which someone's action or inaction may have caused or
				contributed to the individual's death;
(b) Abuse or neglect that required the
				individual's removal from his or her place of residence;
(c) Hospitalization or emergency
				department visit (including observation) as a result of:
(i) Abuse or neglect,
(ii) Accident, injury or
				fall,
(iii) Injury or illness of an unknown
				cause or origin, and
(iv) Reoccurrence within seven calendar
				days of the individual's discharge from a hospital;
(d) Harm to multiple individuals as a
				result of an incident;
(e) Injury resulting from the
				authorized or unauthorized use of a restraint, seclusion or restrictive
				intervention;
(f) Incidents involving an employee of
				the case management contractor or provider oversight contractor;
(g) Misappropriation that is valued at
				five hundred dollars or more;
(h) Incidents generated from
				correspondence received from the Ohio attorney general, office of the governor,
				the centers for medicare and medicaid services (CMS) or the federal office of
				civil rights; and
(i) Incidents identified by a public
				media source.
(K) At its discretion, ODM may request
				further review of any incident under investigation, and/or conduct a separate,
				independent review or investigation of any incident.
(L) ODM shall determine when to close
				incident investigations, and shall be responsible for ensuring that all cases
				are properly closed.
(M) If, at any time during the
				discovery or investigation of an incident, it is determined that an employee of
				the case management contractor or provider oversight contractor is or may be
				responsible for, or contributed to, the abuse, neglect, exploitation or death
				of an individual, the case management contractor or provider oversight
				contractor shall immediately notify ODM. ODM shall assume responsibility for
				the investigation in accordance with the procedures set forth in this
				rule.
(N) ODM may impose sanctions upon the
				provider in accordance with rules
				5160-45-06
				and
				5160-45-09
				of the Administrative Code based upon the substantiation of an incident,
				failure to comply with any of the requirements set forth in this rule, failure
				to assure the health and welfare of the individual and/or failure to comply
				with all applicable federal, state and local laws and regulations.
Replaces: 5160-45-05