Regulation 10 Amendment of regulation 20

(1)

Regulation 20 (duty of candour) is amended as follows.

(2)

In paragraph (1), for “A health service body” substitute “Registered persons”.

(3)

In the following provisions, for “health service body” and “health service body’s” substitute “registered person” and “registered person’s” respectively—

(a)

paragraph (2),

(b)

paragraph (3)(a), (b), (c) and (e),

(c)

paragraph (5), and

(d)

paragraph (6).

(4)

In paragraph (7)—

(a)

for the definition of “notifiable safety incident” substitute—

““notifiable safety incident” has the meaning given in paragraphs (8) and (9);”,

(b)

after that definition insert—

““prolonged pain” means pain which a service user has experienced, or is likely to experience, for a continuous period of at least 28 days;”, and

(c)

in sub-paragraph (c) of the definition of “relevant person” omit “(as determined in accordance with sections 2 and 3 of the 2005 Act)”.

(5)

After paragraph (7) insert—

“(8)
In relation to a health service body, “notifiable safety incident” means any unintended or unexpected incident that occurred in respect of a service user during the provision of a regulated activity that, in the reasonable opinion of a health care professional, could result in, or appears to have resulted in—

(a)
the death of the service user, where the death relates directly to the incident rather than to the natural course of the service user’s illness or underlying condition, or

(b)
severe harm, moderate harm or prolonged psychological harm to the service user.

(9)
In relation to any other registered person, “notifiable safety incident” means any unintended or unexpected incident that occurred in respect of a service user during the provision of a regulated activity that, in the reasonable opinion of a health care professional—

(a)
appears to have resulted in—

(i)
the death of the service user, where the death relates directly to the incident rather than to the natural course of the service user’s illness or underlying condition,

(ii)
an impairment of the sensory, motor or intellectual functions of the service user which has lasted, or is likely to last, for a continuous period of at least 28 days,

(iii)
changes to the structure of the service user’s body,

(iv)
the service user experiencing prolonged pain or prolonged psychological harm, or

(v)
the shortening of the life expectancy of the service user; or

(b)
requires treatment by a health care professional in order to prevent—

(i)
the death of the service user, or

(ii)
any injury to the service user which, if left untreated, would lead to one or more of the outcomes mentioned in sub-paragraph (a).”