Health Bill

House of Commons

Session 2005 - 06
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Health Bill

Health Bill
Part 2 — Prevention and Control of Health Care Associated Infections
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Part 2
Prevention and Control of Health Care Associated Infections
13
Code of practice relating to health care associated infections
After section 47 of the Health and Social Care (Community Health and
Standards) Act 2003 (c. 43) (referred to in this Act as “the 2003 Act”) insert—
5
“47A
Code of practice relating to health care associated infections
(1)
The Secretary of State may issue a code of practice—
(a)
applying to bodies within subsection (2), and
(b)
relating to the prevention and control of health care associated
infections in connection with health care provided by or for
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those bodies.
(2)
The bodies within this subsection are—
(a)
English NHS bodies other than Strategic Health Authorities;
and
(b)
cross-border SHAs.
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(3)
The code may provide for provisions of the code to apply to—
(a)
such description or descriptions of bodies within subsection (2)
as may be specified in the code;
(b)
such body or bodies within that subsection as may be so
specified.
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(4)
The code may in particular—
(a)
make such provision as the Secretary of State considers
appropriate for the purpose of safeguarding individuals
(whether receiving health care or otherwise) from the risk, or
any increased risk, of being exposed to health care associated
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infections;
(b)
contain provisions imposing on bodies to which the provisions
apply requirements in relation to health care provided for such
bodies by other persons as well as in relation to health care
provided by such bodies.
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(5)
The code may—
(a)
operate by reference to provisions of other documents specified
in it (whether published by the Secretary of State or otherwise);
(b)
provide for any reference in it to such a document to take effect
as a reference to that document as revised from time to time;
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(c)
make different provision for different cases or circumstances.
(6)
Nothing in subsections (3) to (5) is to be read as prejudicing the
generality of subsection (1).
(7)
The Secretary of State must keep the code under review and may from
time to time—
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(a)
revise the whole or any part of the code, and
(b)
issue a revised code.
(8)
In this section “health care associated infection” means any infection to
which an individual may be exposed in circumstances where—

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Part 2 — Prevention and Control of Health Care Associated Infections
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(a)
health care is being, or has been, provided to that or any other
individual, and
(b)
the risk of exposure to the infection is directly or indirectly
attributable to the provision of the health care.
(9)
But subsection (8) does not include an infection to which the individual
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is deliberately exposed as part of any health care.
(10)
Any reference in this Part to a code of practice issued under this section
includes a revised code issued under it.
47B
Consultation etc.
(1)
Where the Secretary of State proposes to issue a code of practice under
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section 47A, he must—
(a)
prepare a draft of the code, and
(b)
consult such persons as he considers appropriate about the
draft.
(2)
Where the Secretary of State proposes to issue a revised code under
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section 47A which in his opinion would result in a substantial change
in the code, he must—
(a)
prepare a draft of the revised code, and
(b)
consult such persons as he considers appropriate about the
change.
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(3)
Where, following consultation under subsection (1) or (2), the Secretary
of State issues the code or revised code (whether in the form of the draft
or with such modifications as he thinks fit), it comes into force at the
time when it is issued by the Secretary of State.
(4)
Where—
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(a)
any document by reference to whose provisions the code
operates as mentioned in section 47A(5)(a) and (b) is a
document published by the Secretary of State in connection
with his functions relating to health,
(b)
the Secretary of State proposes to revise the document, and
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(c)
in the opinion of the Secretary of State, the revision would result
in a substantial change in the code,

the Secretary of State must, before revising the document, consult such
persons as he considers appropriate about the change.
(5)
Where—
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(a)
any document by reference to whose provisions the code
operates as mentioned in section 47A(5)(a) and (b) is not one to
which subsection (4)(a) above applies,
(b)
the document is revised, and
(c)
in the opinion of the Secretary of State, the revision results in a
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substantial change in the code,

the Secretary of State must consult such persons as he considers
appropriate about whether the code should be revised in connection
with the change.
(6)
Consultation undertaken by the Secretary of State before the
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commencement of this section is as effective for the purposes of this
section as consultation undertaken after that time.

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Part 2 — Prevention and Control of Health Care Associated Infections
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47C
Effect of code under section 47A
(1)
Where any provisions of a code of practice issued under section 47A
apply to an NHS body, the body must observe those provisions in
discharging its duty under section 45.
(2)
A failure to observe any provision of a code of practice issued under
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section 47A does not of itself make a person liable to any criminal or
civil proceedings.
(3)
A code of practice issued under section 47A is admissible in evidence
in any criminal or civil proceedings.”
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Code of practice: effects on existing functions of Commission for Healthcare
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Audit and Inspection
(1)
Sections 50 to 52 and 54 of the 2003 Act are amended as follows.
(2)
In section 50 (annual reviews), for subsection (4) substitute—
“(4)
In exercising its functions under this section in relation to any health
care, the CHAI must take into account—
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(a)
the standards set out in statements published under section 46,
and
(b)
any code of practice issued under section 47A.
(4A)
In conducting a review under subsection (1) in relation to a particular
body to which provisions of such a code apply, the CHAI must
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accordingly consider (among other things) the extent, if any, to which
those provisions are being observed by the body.”
(3)
In section 51 (reviews: England and Wales), in subsection (4)(a) after “section
46” insert “and any code of practice issued under section 47A”.
(4)
In section 52 (reviews and investigations: England), for subsection (3)
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substitute—
“(3)
The CHAI has the function of conducting reviews of—
(a)
the arrangements made by English NHS bodies and cross-
border SHAs for the purpose of discharging their duty under
section 45;
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(b)
the arrangements made by particular bodies within paragraph
(a) for the purpose of discharging that duty.”
(5)
For section 52(5) substitute—
“(5)
In exercising its functions under this section in relation to any health
care, the CHAI must take into account—
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(a)
the standards set out in statements published under section 46,
and
(b)
any code of practice issued under section 47A.
(5A)
In conducting a review under subsection (3) in relation to a particular
body to which provisions of such a code apply, the CHAI must
40
accordingly consider (among other things) the extent, if any, to which
those provisions are being observed by the body.”

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Part 2 — Prevention and Control of Health Care Associated Infections
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(6)
In section 54 (functions relating to Secretary of State and Assembly), in
subsection (2) after “section 46 or 47” insert “, or any code of practice issued
under section 47A,”.
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Code of practice: improvement notices
After section 53 of the 2003 Act insert—
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“53A
Failings in connection with code under section 47A: improvement
notices
(1)
This section applies where, following such a review or investigation as
is mentioned in section 53(1), the CHAI—
(a)
is of the view that any provisions of a code of practice issued
10
under section 47A and applying to an English NHS body or a
cross-border SHA are not being observed in any material
respect in relation to the provision of health care by or for the
body, but
(b)
having regard to all the circumstances, is not of the view that it
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is required to make a report under section 53(2) (or, if relevant,
section 53(6)).
(2)
The CHAI may serve a notice under this section (an “improvement
notice”) on the body in respect of the failure to observe the code, if it
considers that serving the notice is the most appropriate course of
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action for it to take with a view to securing that the failure is remedied.
(3)
An improvement notice must—
(a)
state that the CHAI has formed the view mentioned in
subsection (1)(a) in relation to the provision of health care by or
for the body, giving particulars of the material respect in which
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the CHAI considers that the provisions of the code are not being
observed as mentioned in that subsection,
(b)
state the CHAI’s reasons for its view, and
(c)
require the body to remedy the failure to observe the code, and
to do so within such period as is specified in the notice.
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(4)
An improvement notice may (but need not) include a recommendation
by the CHAI as to the way in which the failure should be remedied.
(5)
An improvement notice may relate to more than one failure within
subsection (1)(a), and in such a case—
(a)
subsections (2) to (4) and section 53B apply separately in
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relation to each such failure, but
(b)
any report required by that section may relate to more than one
such failure.
(6)
Where the CHAI serves an improvement notice on a body under this
section, the CHAI must notify the Secretary of State and—
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(a)
the regulator, if the body is an NHS foundation trust, and
(b)
any relevant Strategic Health Authority, if the body is a Primary
Care Trust or an NHS trust.
(7)
In this section and section 53B “relevant Strategic Health Authority”
means—
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Part 2 — Prevention and Control of Health Care Associated Infections
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(a)
in relation to a Primary Care Trust, any Strategic Health
Authority whose area includes any part of the Trust’s area;
(b)
in relation to an NHS Trust (other than one responsible for
providing ambulance services), the Strategic Health Authority
in whose area all or most of the Trust’s hospitals,
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establishments or facilities are situated;
(c)
in relation to an NHS Trust responsible for providing
ambulance services, the Strategic Health Authority in whose
area the headquarters establishment responsible for the control
of those services is situated.
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(8)
Subsection (9) applies where—
(a)
an improvement notice is served on a body in respect of a
particular failure to observe a code of practice issued under
section 47A, and
(b)
a review under section 52(3)(b) is conducted by the CHAI in
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pursuance of section 53B(4)(a) with a view to assessing the
body’s compliance with the notice.
(9)
In such a case subsection (1)—
(a)
does not apply in relation to that review so as to enable the
CHAI to serve a further improvement notice on that body in
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respect of that failure; but
(b)
does apply in relation to that review so as to enable the CHAI (if
the conditions in subsections (1) and (2) are satisfied) to serve an
improvement notice on that body in respect of a different failure
to observe the code.
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53B
Code of practice: action by CHAI following service of improvement
notice
(1)
This section applies where the CHAI has served an improvement notice
on a body under section 53A.
(2)
If, before the end of the specified period—
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(a)
the body requests the CHAI to extend that period, and
(b)
the CHAI considers that there are exceptional circumstances
which justify its extending that period by a further period of
time,

the CHAI may, by a notice served on the body, extend the specified
35
period by that further period.
(3)
In this section “the specified period” means—
(a)
the period specified under section 53A(3)(c), or
(b)
if that period has been extended under subsection (2) above,
that period as so extended.
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(4)
Where the specified period has ended or the body notifies the CHAI
before the end of that period that it has complied with the improvement
notice, the CHAI must—
(a)
conduct a review under section 52(3)(b) with a view to assessing
the body’s compliance with the notice, and
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(b)
then comply with subsection (5) or (6);

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and the making of any report in accordance with subsection (5) or (6) is
to be taken as satisfying the requirement to publish a report under
section 52(7) in respect of the review.
(5)
If the CHAI—
(a)
remains of the view that the relevant provisions of the code are
5
not being observed in any material respect in relation to the
provision of health care by or for the body, and
(b)
having regard to all the circumstances, is of the view that it is
required to make a report under section 53(2) (and, if relevant,
section 53(6)),
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the CHAI must accordingly make a report under that provision (or, as
the case may be, under each of those provisions).
(6)
If the CHAI does not make any such report or reports, it must instead
make a report—
(a)
to the Secretary of State, and
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(b)
(if the body is an NHS foundation trust) to the regulator,

setting out the matters mentioned in subsection (7) or (8).
(7)
If the CHAI is of the view that the relevant provisions of the code are
being observed in relation to the provision of health care by or for the
body, the matters are—
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(a)
that the CHAI is of that view, and
(b)
its reasons for that view.
(8)
If the CHAI is of the view that the relevant provisions of the code are
not being so observed in any respect (material or otherwise), the
matters are—
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(a)
that the CHAI is of that view,
(b)
its reasons for that view,
(c)
if its view is that those provisions are not being observed in any
material respect, its reasons for not forming the view mentioned
in subsection (5)(b), and
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(d)
(whether or not paragraph (c) applies) any action which it
proposes to take in relation to the body in connection with the
failure to observe the code.
(9)
The CHAI must send a copy of any report made by it in accordance
with subsection (5) or (6) in relation to a Primary Care Trust or an NHS
35
trust to the relevant Strategic Health Authority.
(10)
In this section “the relevant provisions of the code” means the
provisions of the code in relation to which the CHAI formed the view
mentioned in section 53A(1)(a).”

Health Bill
Part 3 — Drugs, Medicines and Pharmacies
Chapter 1 — Supervision of management and use of controlled drugs
14

Part 3
Drugs, Medicines and Pharmacies
Chapter 1
Supervision of management and use of controlled drugs
16
Accountable officers and their responsibilities as to controlled drugs
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(1)
The relevant authority may by regulations make provision for or in connection
with requiring designated bodies to nominate or appoint persons who are to
have prescribed responsibilities in relation to the safe, appropriate and
effective management and use of controlled drugs in connection with—
(a)
activities carried on by or on behalf of the designated bodies, and
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(b)
activities carried on by or on behalf of bodies or persons providing
services under arrangements made with the designated bodies.
(2)
The person who is to be so nominated or appointed by a designated body is to
be known as its accountable officer.

This is subject to any regulations made by virtue of subsection (5)(e).
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(3)
In this Chapter “designated body” means—
(a)
a body falling within any description of bodies prescribed as
designated bodies for the purposes of this section, or
(b)
a body prescribed as a responsible body for those purposes.
(4)
The bodies that may be prescribed as designated bodies for the purposes of this
20
section are bodies appearing to the relevant authority—
(a)
to be directly or indirectly concerned with the provision of health care
(whether or not for the purposes of the health service), or
(b)
to be otherwise carrying on activities that involve, or may involve, the
supply or administration of controlled drugs.
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(5)
Regulations under this section may make provision—
(a)
for conditions that must be satisfied in relation to a person if he is to be
nominated or appointed by a designated body as the body’s
accountable officer;
(b)
for a single person to be nominated or appointed as the accountable
30
officer for each of two or more designated bodies where those bodies
are satisfied as to the prescribed matters;
(c)
requiring a designated body that has an accountable officer to provide
the officer with funds and other resources necessary for enabling the
officer to discharge his responsibilities as accountable officer for the
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body;
(d)
for ensuring that an accountable officer, in discharging his
responsibilities, has regard to best practice in relation to the use of
controlled drugs;
(e)
for the persons required to be nominated or appointed as mentioned in
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subsection (1) to be known by such name as is prescribed;
(f)
for making such amendments of any enactment as appear to the
relevant authority to be required in connection with any provision
made in pursuance of paragraph (e);