Current through Register Vol. 43, No. 39, September 26, 2024
(a) Each
applicant and each licensee shall develop and implement a written risk
management plan.
(b) The risk
management plan shall be reviewed and approved annually by the
licensee.
(c) Findings,
conclusions, recommendations, actions taken, and results of actions taken shall
be documented and reported through procedures established within the risk
management plan.
(d) All patient
services, including those services provided by outside contractors or
consultants, shall be periodically reviewed and evaluated in accordance with
the risk management plan.
(e) Each
risk management plan shall include the following:
(1) Section I. A description of the system
implemented by the facility for investigation and analysis of the frequency and
causes of reportable incidents within the facility;
(2) Section II. A description of the measures
used by the facility to minimize the occurrence of reportable incidents and the
resulting injuries within the facility;
(3) Section III. A description of the
facility's implementation of a reporting system based upon the duty of all
medical staff members staffing the facility and all agents and staff members of
the facility directly involved in the delivery of health care services to
report reportable incidents; and
(4) Section IV. A description of the
organizational elements of the plan, including the following:
(A) Name and address of the
facility;
(B) name and title of the
facility's risk manager; and
(C)
description of involvement and organizational structure of medical staff
members as related to the risk management program, including names and titles
of medical staff members involved in investigation and review of reportable
incidents.
(f) The standards-of-care determinations
shall include the following:
(1) Each
facility shall assure that analysis of patient care incidents complies with the
definition of a "reportable incident." Each facility shall use categories to
record its analysis of each incident, and those categories shall be in
substantially the following form:
(A)
Standards of care met;
(B)
standards of care not met, but with no reasonable probability of causing
injury;
(C) standards of care not
met, with injury occurring or reasonably probable; or
(D) possible grounds for disciplinary action
by the appropriate licensing agency.
(2) Each reported incident shall be assigned
an appropriate standard-of-care determination. Separate stan-dard-of-care
determinations shall be made for each involved medical staff member and each
clinical issue reasonably presented by the facts. Any incident determined to
meet paragraph (f)(1)(C) or (D) of this regulation shall be reported to the
appropriate licensing agency.
