Current through Register Vol. 46, No. 39, September 25, 2024
(a) Mental health providers are responsible
for compiling and analyzing incident data for Reportable Incidents, incidents
reported to the Office pursuant to Section
524.10
of this Part, and patient death, for the purpose of identifying possible
patterns and trends and to determine the timeliness, thoroughness, and
appropriateness of the provider's responses.
(1) At a minimum, incident data shall be
analyzed according to incident type, patient involvement, location, date, and
time, and employee involvement.
(2)
Reviews shall not be considered to be complete until all relevant information,
(including final investigation reports and relevant systems analyses), has been
gathered, opportunities for improvement have been identified, and, if deemed
necessary, plans of correction/prevention have been developed, implemented, and
monitored.
(3) For investigations
of reportable incidents, correction/prevention plans must be documented in
accordance with guidelines of the Office.
(b) Incident Review Committees. Each mental
health provider shall appoint a standing Incident Review Committee to assure
that all Reportable Incidents, incidents reported to the Office pursuant to
Section
524.10
of this Part, and patient death, are reviewed and monitored, that all incidents
that may adversely affect the care and safety of patients are appropriately
addressed, and that preventive and corrective measures are identified, as
appropriate.
(1) Incident Review Committees
may be organized on a provider-wide, multi-program or program-specific basis,
and may have responsibilities other than those related to incident management.
The composition of an Incident Review Committee must be such that a free and
open exchange of information is ensured, in order to facilitate full and
complete investigations. Providers shall maintain current documentation
attesting that committee membership at least includes:
(i) members of the governing body of the
mental health provider;
(ii)
persons identified by the director of such provider, including some members of
the following:
(a) direct support staff,
which shall mean staff who are involved in the provision of direct care
services;
(b) licensed health care
practitioners;
(c) service
recipients; and
(d) representatives
of family, consumer, or advocacy organizations.
(2) The director of the mental health
provider shall not be a member of the Incident Review Committee. For purposes
of this Section, "director" shall mean:
(i)
the Executive Director of a State operated facility; or
(ii) the Chief Executive Officer of a
licensed provider of mental health services, as designated by the signatory (or
his/her successor) of the Prior Approval Review form Part A Acknowledgment
submitted in accordance with Part 551 of this title.
(3) The Incident Review Committee shall
include a physician, on a regular membership or ad hoc basis.
The physician shall participate in review of all medically related
incidents.
(4) The scheduling of
Incident Review Committee meetings shall in no way preclude the prompt and
thorough review of each incident. Each Incident Review Committee shall meet
within 45 days of completion of any pending investigation, or sooner, should
the circumstances so warrant, but no less frequently than on a quarterly basis,
to allow for the timely review and closure of incidents.
(5) Incident review committees shall take an
active role in assuring that:
(i) Incidents
are reported, managed, investigated and documented consistent with the
provisions of this Part and with the provider's policies and procedures, and
written recommendations are made to the appropriate staff and/or the director
of the provider of services to correct, improve or eliminate
inconsistencies;
(ii) necessary and
appropriate corrective, preventive, and/or disciplinary action is taken to
protect persons receiving services from harm and to safeguard against the
recurrence of similar incidents;
(iii) if further investigation or if
additional corrective, preventive, and/or disciplinary action is necessary,
appropriate written recommendations are made to the director of the provider
relative to the incident;
(iv)
trends in incidents, (e.g., by type, person, site, employee involvement, time,
date, circumstances, etc.), are identified, and recommendations are made
regarding appropriate corrective, preventive, and/or disciplinary action to the
director to safeguard against and reduce such recurring situations or
incidents; and
(v) the provider's
reporting and review practices, including the monitoring of the implementation
of approved recommendations for corrective and preventive action, are
effective.
(6) Incident
review committee members who may bear some responsibility for an incident shall
be excluded from the committee's deliberations regarding that
incident.
(7) Written minutes of
all meetings shall be maintained.
(i) Minutes
shall indicate when review of a particular incident has been completed. Review
shall be deemed complete when all relevant information, including the final
investigative report, has been gathered, opportunities for improvement have
been identified, and plans of correction/prevention have been developed and
implemented.
(ii) Minutes are to
be filed and otherwise maintained in a manner that ensures
confidentiality.
(8)
Reports based on the minutes shall be developed and submitted to the director
of the mental health provider, as determined necessary by the committee. Such
reports shall include a summary of the Committee's discussions, findings and
recommendations, as well as follow-up actions taken to assure that all
recommended preventive and/or corrective measure(s) are implemented.
(9) All members of the Incident Review
Committee must be trained in relevant confidentiality laws and
regulations