Current through all regulations passed and filed through September 16, 2024
(A)
The Ohio department of medicaid (ODM) or its designee
(hereafter referred to as 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 of specialized recovery services (hereafter referred to as
providers). ODM may designate other agencies or entities to perform one or more
of the incident management functions set forth in this rule.
(B)
When the
individual is a MyCare Ohio member, this rule is not applicable. Refer to rule
5160-58-05.3 of the
Administrative Code for incident management responsibilities.
(C)
ODM shall ensure
the health and welfare of individuals enrolled in the program. ODM and
providers are responsible for ensuring individuals in the specialized recovery
services program 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 in
the program, must acknowledge in writing they have reviewed this rule and
related procedures.
(E)
Upon an individual's enrollment in the program, and at
the time of each annual reassessment, the recovery manager shall provide the
individual and/or the individual's authorized representative or legal guardian
with documentation about how to report abuse, neglect, exploitation and other
incidents. The recovery manager shall secure from the individual, authorized
representative and/or legal guardian written confirmation of receipt of the
documentation and it shall be maintained in the individual's
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 in, 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 that meets the criteria for a suspicious death as described in
paragraph (J)(2)(a) of this rule.
(6)
Death of an
individual that does not meet the criteria for a suspicious death as described
in paragraph (J)(2)(a) of this rule.
(7)
Hospitalization
or emergency department visit (including observation) as a result of:
(a)
Accident, injury
or fall when someone's action or inaction may have caused or contributed to the
occurrence, including inadequate oversight of medication or misuse of
medication;
(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.
(8)
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.
(9)
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.
(10)
Inappropriate service delivery including, but not
limited to:
(a)
A provider's violation of the requirements set forth in rule
5160-43-04 of the Administrative
Code and/or any other Administrative Code rules referenced therein that results
in an inability to assure the individual's health and welfare, or could
reasonably be expected to place the individual's health and welfare in
jeopardy;
(b)
Services provided to the individual that are beyond the
provider's scope of practice; and
(c)
Medication
administration errors involving the individual.
(11)
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)
Activities that
involve law enforcement;
(b)
Misuse of medications;
(c)
Use of illegal
substances; and
(d)
The individual cannot be located.
(G)
Incident reporter responsibilities.
(1)
Individuals
and/or their authorized representative or legal guardian should report
incidents to the individual's recovery manager and the appropriate
authorities.
(2)
ODM and all providers are required to report incidents
and shall do all of the following:
(a)
Take immediate action to ensure the health and welfare
of the individual which may include, but is not limited to, seeking or
providing medical attention.
(b)
Immediately
report any incident(s) set forth in paragraphs (F)(1) to (F)(5) of this rule to
the recovery manager and the appropriate authorities set forth in paragraph
(G)(4)(a) of this rule.
(c)
Report any incidents set forth in paragraphs (F)(6) to
(F)(11) of this rule to the recovery manager within twenty-four hours unless
bound by federal, state or local law or professional licensure or certification
requirements to report sooner.
(d)
Report all
incidents to his or her supervisor when he or she has a
supervisor.
(3)
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 all persons involved and corresponding
contact information when available.
(4)
The appropriate
authority is dependent upon the nature of the incident. Examples of appropriate
authorities include, but are not limited to:
(a)
The following
local agencies that hold investigative and/or protective authority:
(i)
Law enforcement
when 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)
Coroner's
office;
(iii)
County board of developmental
disabilities;
(iv)
Public children services agency; and
(v)
Public adult
protective services agency.
(b)
The following
regulatory, oversight and/or advocacy agencies:
(i)
The Ohio
long-term care ombudsman;
(ii)
Any Ohio,
national or federal licensure, certification or accreditation entity when the
allegation involves a provider regulated by that entity;
(iii)
The Ohio
attorney general when the allegation is suspected to involve medicaid fraud by
the provider; and
(iv)
The local probate court when the allegation is
suspected to involve the individual's legal guardian.
(H)
Recovery management contractor responsibilities.
(1)
The recovery
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 individual(s) who may be at-risk;
(b)
Notify the
appropriate agencies that hold investigative and/or protective authority as set
forth in paragraph (G)(4)(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 regulatory, oversight and/or advocacy agencies set forth in
paragraph (G)(4)(b) of this rule; and
(d)
Notify the
individual's primary care provider.
(2)
The recovery
management contractor shall complete an incident report in the ODM-approved
system within twenty-four hours of discovery if the incident was one of those
set forth in paragraphs (F)(1) to (F)(11) of this rule.
(3)
The recovery
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 recovery management contractor shall notify the
individual and/or individual's authorized representative or legal guardian of
the incident 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 the ODM-approved assessment and
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 death of an individual when the individual died as a result of
criminal or other violent means, by casualty, by suicide, or in any suspicious
or unusual manner, or died suddenly when in apparent good health or when the
individual had a developmental disability, regardless of the circumstances, and
in accordance with section
313.12 of the Revised Code. 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 time frame 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.
(f)
Upon
substantiating an incident that involves a program provider, the provider
oversight contractor shall notify ODM.
(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 which the incident was reported and that may be
conducting separate investigations.
(b)
Conduct a review
of all relevant documents including, but not limited to, assessments, clinical
notes, person-centered plans of care, communication notes, coroner's reports,
documentation available from other authorities, provider documentation,
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
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 safe and
appropriate.
(e)
When applicable, make referrals to the 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 the provider oversight contractor
discovers an incident that meets the criteria for a suspicious death as
described in paragraph (J)(2)(a) of this rule, 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 ODM 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.
(4)
Incidents set forth in paragraph (F)(6) of this rule
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.
(5)
Conducting 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, and excluding
the incidents set forth in paragraph (F)(6) of this rule, 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 if it
was preventable; and
(c)
Includes a prevention plan for the individual that
identifies steps necessary to mitigate the effects of a substantiated incident,
eliminates the causes that resulted in risk to the health and welfare of the
individual and helps to prevent future incidents.
(ii)
Notify program
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 to mitigate against the causes of and factors contributing
to the incident; and
(d)
The time frame within which the provider must submit a
plan of correction to the provider oversight contractor in accordance with rule
5160-43-07 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)
Ensure that all
such reports issued 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 identification and report submission.
(2)
The following
incidents are cause for an alert:
(a)
A suspicious death that could not reasonably have been
expected, and in which at least one of the following circumstances
exists:
(i)
The
circumstances and/or the cause of death are not related to any known medical
condition of the individual; or
(ii)
Someone's action
or inaction may have caused or contributed to the individual's death, including
inadequate oversight of medication or misuse of medication.
(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 when someone's action or
inaction may have caused or contributed to the occurrence, including inadequate
oversight of medication or misuse of medication;
(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 people 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 recovery 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 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 recovery management
contractor is or may be responsible for, or contributed to, the abuse, neglect,
exploitation or death of an individual, the recovery 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 rule
5160-43-07 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 ensure the health and
welfare of the individual and/or failure to comply with all applicable federal,
state and local laws and regulations.
