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HOSPITAL AND HEALTH BOARDS REGULATION 2023 - REG 37
Reportable events
(1) For section 94 of the Act , definition
"reportable event" , each of the following events is prescribed— (a) surgery
or another invasive procedure being performed on the wrong site of a
patient’s body resulting in serious harm to the patient or the death of the
patient;
(b) surgery or another invasive procedure being performed on the
wrong patient resulting in serious harm to the patient or the death of the
patient;
(c) the wrong surgical or other invasive procedure being performed
on a patient resulting in serious harm to the patient or the death of the
patient;
(d) the unintended retention of a foreign object in a patient after
surgery or another invasive procedure resulting in serious harm to the patient
or the death of the patient;
(e) a haemolytic blood transfusion reaction
caused by ABO incompatibility resulting in serious harm to or the death of the
patient receiving the blood transfusion;
(f) the suspected suicide of a
patient within an acute psychiatric unit or ward;
(g) an error relating to a
patient’s medication resulting in serious harm to the patient or the death
of the patient;
(h) the use of physical or mechanical restraint resulting in
serious harm to a patient or the death of a patient;
(i) the use of an
incorrectly positioned orogastric or nasogastric tube resulting in
serious harm to a patient or the death of a patient;
(j) the discharge or
release of a patient who is a child under the age of 15 years to an
unauthorised person;
(k) a stillbirth;
(l) any death of a patient, or
serious harm or other harm to a patient that is likely to be permanent,
that— (i) is not mentioned in paragraphs (a) to (i) ; and
(ii) was not
reasonably expected to be an outcome of the health service provided to the
patient.
(2) For subsection (1) (f) , an
"acute psychiatric unit or ward" is a specialised unit or ward, including a
unit or ward within an emergency department, for the treatment and care of
admitted patients with a mental illness if the unit or ward— (a) is
specifically designed with fixtures and fittings that minimise the opportunity
for patient suicide; and
(b) is specifically designed to prevent any
unauthorised ingress or egress; and
(c) is subject to protocols for the
observation of patients within the unit or ward.
(3) In this section—
"ABO incompatibility" , in relation to a blood transfusion received by a
patient, means the use of an incompatible blood group for the patient in the
transfusion.
"invasive procedure" means a medical procedure that enters a person’s body
including, for example, by cutting or puncturing the skin or by inserting a
needle, tube, device or scope into the body.
"mechanical restraint" means a device that controls a person’s freedom of
movement.
"mental illness" see the Mental Health Act 2016 , section 10 .
"serious harm" , for a patient, means harm to the patient— (a) that requires
life-saving surgical or medical intervention; or
(b) shortens the patient’s
life expectancy; or
(c) that is permanent or long-term physical harm; or
(d)
that is a permanent or long-term loss of a physical function.
"stillbirth" means the birth of a child— (a) who shows no sign of
respiration or heartbeat, or other sign of life, after completely leaving the
child’s mother’s body; and
(b) who— (i) has been gestated for 20 weeks
or more; or
(ii) weighs 400g or more.
"unauthorised person" , in relation to a child, means a person who— (a) is
not a parent or legal guardian of the child; or
(b) is not acting under the
express or implied authority of a parent or legal guardian of the child for
the purpose of subsection (1) (j) ; or
(c) is prevented from having access to
the child by an order of a court or tribunal.
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