(1)A responsible person must follow the duty of candour procedure set out in section 22 as soon as reasonably practicable after becoming aware that subsection (2) applies to a person who has received—
(a)a health service from the responsible person,
(b)a care service from the responsible person, or
(c)a social work service from the responsible person.
(2)This subsection applies to a person if—
(a)an unintended or unexpected incident occurred in the provision of a health service, a care service or a social work service to the person, and
(b)in the reasonable opinion of a registered health professional—
(i)that incident appears to have resulted in or could result in an outcome mentioned in subsection (4), and
(ii)that outcome relates directly to the incident rather than to the natural course of the person's illness or underlying condition.
(3)For the purposes of subsection (2)(b), a responsible person must ensure that the registered health professional who gives the opinion following an unintended or unexpected incident is not an individual who was involved in the incident.
(4)The outcomes are—
(a)the death of the person,
(b)a permanent lessening of bodily, sensory, motor, physiologic or intellectual functions (including removal of the wrong limb or organ or brain damage) (“severe harm”),
(c)harm which is not severe harm but which results in—
(i)an increase in the person's treatment,
(ii)changes to the structure of the person's body,
(iii)the shortening of the life expectancy of the person,
(iv)an impairment of the sensory, motor or intellectual functions of the person which has lasted, or is likely to last, for a continuous period of at least 28 days,
(v)the person experiencing pain or psychological harm which has been, or is likely to be, experienced by the person for a continuous period of at least 28 days,
(d)the person requiring treatment by a registered health professional in order to prevent—
(i)the death of the person, or
(ii)any injury to the person which, if left untreated, would lead to one or more of the outcomes mentioned in paragraph (b) or (c).
(5)The Scottish Ministers may by regulations modify subsection (4).
Commencement Information
I1S. 21 in force at 1.10.2017 for specified purposes by S.S.I. 2017/294, reg. 2, sch.
I2S. 21 in force at 1.4.2018 in so far as not already in force by S.S.I. 2018/56, art. 2, sch.