Health and Care Bill (HL Bill 71)

Part 4 continued    

(c)sets out, in general terms, the issues that the HSSIB expects to consider
in the investigation.

(6)The HSSIB may give advance notice of a statement under subsection (5) to any
person the HSSIB considers may be affected by the investigation.

(7)5Where the HSSIB discontinues an investigation, it must, in such manner as it
thinks appropriate, publish a statement which—

(a)reports that it has discontinued the investigation, and

(b)gives its reasons for doing so.

(8)Where the HSSIB determines not to investigate a qualifying incident, it may
10give notice of its determination to any person the HSSIB considers to have an
interest in the determination.

(9)Notice under subsection (8) may include—

(a)a brief description of the incident, and

(b)the HSSIB’s reasons for not investigating it.

98 15Criteria, principles and processes

(1)The HSSIB must determine and publish—

(a)the criteria it will use in determining which incidents it investigates,

(b)the principles which are to govern investigations,

(c)the processes to be followed in carrying out investigations, and

(d)20the processes for ensuring that, so far as reasonable and practicable,
patients and their families are involved in investigations.

(2)The processes determined under subsection (1)(c) must include—

(a)the procedures and methods to be used in investigations (including in
the interviewing of persons), and

(b)25the time periods within which the HSSIB aims to complete
investigations.

(3)Different processes under subsection (1)(c) or (d) may be determined for
different descriptions of investigation.

(4)Anything published under subsection (1)(d) must be—

(a)30easily accessible to patients and their families, and

(b)capable of being easily understood by them.

(5)The HSSIB must review the criteria, principles and processes—

(a)within the period of three years beginning with their publication under
subsection (1), and

(b)35subsequently within each period of five years beginning with the
completion of the previous review.

(6)If the HSSIB revises the criteria, principles and processes it must publish them
as revised.

(7)In determining or revising the criteria, principles and processes the HSSIB
40must consult—

(a)the Secretary of State, and

(b)any other persons the HSSIB considers appropriate.

Reports

99 Final reports

(1)When the HSSIB completes an investigation, it must publish a report on the
outcome of the investigation (the “final report”).

(2)5The final report must—

(a)contain a statement of findings of fact made as a result of the
investigation and an analysis of those findings,

(b)make such recommendations as to the action to be taken by any person
as the HSSIB considers appropriate, and

(c)10set out the HSSIB’s conclusions on the matters it considered in
accordance with section 96(3) (but only if that provision is applicable to
the investigation).

(3)The final report must focus on ascertaining risks to the safety of patients and
any recommendations as to the action to be taken by any person must focus on
15addressing those risks (rather than on the activities of individuals involved in
the incident).

(4)In particular, the final report may not include an assessment or determination
of—

(a)blame,

(b)20civil or criminal liability, or

(c)whether action needs to be taken in respect of an individual by a
regulatory body.

(5)Information which is protected material (see section 108(2)) may be disclosed
in a final report if the HSSIB determines that the benefits to the safety of
25patients served by the disclosure outweigh—

(a)any adverse impact on current or future investigations by deterring
persons from providing information to the HSSIB, and

(b)any adverse impact on securing the improvement of the safety of health
care services provided to patients in England.

(6)30The final report may not, without their consent, include the name of any
individual—

(a)who has provided information to the HSSIB for the purposes of the
investigation, or

(b)who was involved in the incident being investigated.

(7)35Where an investigation is carried out pursuant to a direction under section 97,
the HSSIB must send a copy of the final report to the Secretary of State.

100 Interim reports

(1)While the HSSIB is carrying out an investigation, it may publish a report on any
matter relating to the investigation (an “interim report”).

(2)40An interim report may—

(a)contain a statement of findings of fact made as a result of the
investigation to date and an analysis of those findings,

(b)make such recommendations as to the action to be taken by any person
as the HSSIB considers appropriate, and

(c)set out the HSSIB’s conclusions to date on the matters it has considered
in accordance with section 96(3).

(3)Subsections (3) to (7) of section 99 apply in relation to an interim report as they
apply in relation to a final report.

101 5Draft reports

(1)Before it publishes a final or interim report, the HSSIB—

(a)must send a draft of the report to any person who the HSSIB reasonably
believes could be adversely affected by the report, and

(b)may send a draft of the report to any other person who the HSSIB
10believes should be sent a draft.

(2)If a person who the HSSIB reasonably believes could have been adversely
affected by the report has died, the draft report must be sent to the person (if
any) who appears to the HSSIB to best represent the interests of the person who
has died.

(3)15The HSSIB must notify every person to whom a draft report is sent that the
person has an opportunity to comment on the draft report before the deadline
specified by the HSSIB.

(4)If a person’s comments on a draft report are not taken into account in the final
or interim report as published, the HSSIB must explain to the person why that
20is.

102 Response to reports

(1)This section applies where a final or interim report includes recommendations
as to the action to be taken by any person.

(2)The HSSIB must, in such manner as it thinks appropriate, send the report to
25that person or make it available to them.

(3)The report must specify the deadline for that person to provide a written
response.

(4)Before that deadline, the person must respond to the HSSIB in writing setting
out the actions they propose to take in pursuance of the recommendations.

(5)30The HSSIB may publish the response.

(6)Subsection (4) does not require a person to do anything that they could be
required to do by an Act of Senedd Cymru made without the consent of a
Minister of the Crown.

103 Admissibility of reports

(1)35A final report, an interim report and the draft of a final or interim report sent
to a person under section 101 are not admissible in any proceedings within
subsection (2).

(2)Those proceedings are—

(a)proceedings to determine civil or criminal liability in respect of any
40matter;

(b)proceedings before any employment tribunal;

(c)proceedings before a regulatory body (including proceedings for the
purposes of investigating an allegation);

(d)proceedings to determine an appeal against a decision made in
proceedings falling within paragraphs (a) to (c).

(3)5But the High Court may order that a final or interim report is admissible in
proceedings within subsection (2) on an application by a person who is a party
to the proceedings or otherwise entitled to appear in them.

(4)The HSSIB may make representations to the High Court about any application
under subsection (3).

(5)10The High Court may make an order under subsection (3) only if it determines
that the interests of justice served by admitting the report outweigh—

(a)any adverse impact on current or future investigations by deterring
persons from providing information for the purposes of investigations,
and

(b)15any adverse impact on securing the improvement of the safety of health
care services provided to patients in England.

Investigatory powers etc

104 Powers of entry, inspection and seizure

(1)If an investigator considers it necessary for the purposes of an investigation,
20the investigator may—

(a)enter and inspect premises in England, other than premises used
wholly or mainly as a private dwelling;

(b)inspect and take copies of any document at, or capable of being viewed
using equipment at, the premises;

(c)25inspect any equipment or other item at the premises;

(d)seize and remove from the premises any document, equipment or other
item (unless that would risk the safety of any patient).

(2)In subsection (1)(b) the reference to inspecting and taking copies of any
document includes requiring any document which is kept in electronic form to
30be produced in a form in which it is legible and can be taken away.

(3)Where any document, equipment or other item is seized by an investigator, or
any copy of a document is taken, it may be retained by the HSSIB for so long
as is necessary for the purposes of the investigation.

(4)An investigator exercising any power conferred by this section must, if asked,
35produce evidence of the investigator’s authority from the HSSIB to act on its
behalf.

(5)The powers conferred by subsection (1) may be exercised in relation to
premises in which there is a Crown interest, but only if the HSSIB gives
reasonable notice to the occupier of the premises of its intention to enter and
40inspect the premises.

(6)But if the Secretary of State certifies that it appears to the Secretary of State
appropriate in the interests of national security that the powers conferred by
subsection (1)—

(a)should not be exercisable in relation to any premises in which there is a
45Crown interest and which are specified in the certificate, or

(b)should not be exercisable in relation to any such premises which are so
specified except in circumstances specified in the certificate,

those powers are not exercisable in relation to those premises or (as the case
may be) are not exercisable except in the circumstances specified.

(7)5In this section “Crown interest” means—

(a)an interest belonging to a government department or held in trust for
Her Majesty for the purposes of a government department;

(b)an interest belonging to Her Majesty in right of the Crown;

(c)an interest belonging to Her Majesty in right of the Duchy of Lancaster;

(d)10an interest belonging to the Duchy of Cornwall.

105 Powers to require information etc

(1)An investigator may by notice require any person—

(a)to attend at a specified time and place and to provide information by
answering questions;

(b)15to provide specified information, or information of a specified
description, by a specified date;

(c)to provide specified documents, equipment or items, or documents,
equipment or items of a specified description, by a specified date.

(2)An investigator may give a person a notice only if the investigator reasonably
20believes that—

(a)in the case of a requirement under subsection (1)(a), the person is able
to provide information which is necessary for the purposes of an
investigation;

(b)in the case of a requirement under subsection (1)(b)—

(i)25it is necessary to obtain the information for the purposes of an
investigation, and

(ii)the person is able to provide it;

(c)in the case of a requirement under subsection (1)(c)—

(i)it is necessary to obtain the document, equipment or other item
30for the purposes of the HSSIB’s investigation function, and

(ii)the person is able to provide it.

(3)But a person is not required by virtue of subsection (1) to provide any
information, document, equipment or other item where—

(a)its provision would risk the safety of any patient,

(b)35its provision might incriminate the person, or

(c)in the case of information or a document, the person would be entitled
to refuse to provide it in any proceedings in any court on the grounds
that it is the subject of legal professional privilege.

(4)A notice must—

(a)40specify the grounds for the investigator believing the matters in
subsection (2),

(b)give an explanation of the consequences of failing to comply with the
notice (see section 107), and

(c)attach evidence of the investigator’s authority from the HSSIB to
45exercise the powers conferred by this section.

(5)If a notice requires a person to provide anything which is kept in electronic
form, the notice may require it to be provided in a form in which it is legible.

(6)An investigator may withdraw a notice under subsection (1) by giving notice
of withdrawal to the person to whom the notice was given.

(7)5Where any document, equipment or other item is provided to an investigator
pursuant to a notice, it may be retained by the HSSIB for so long as is necessary
for the purposes of the HSSIB’s investigation function, unless its retention
would risk the safety of any patient.

(8)Where a person attends to answer questions pursuant to a notice under
10subsection (1)(a), the HSSIB—

(a)must reimburse the person the reasonable costs incurred in attending;

(b)may record, by any means, the answers given.

(9)In this section “specified” means specified in the notice.

106 Voluntary provision of information etc

15A person may disclose any information, document, equipment or other item to
the HSSIB if the person reasonably believes that the disclosure is necessary for
the purpose of enabling the HSSIB to carry out its investigation function.

107 Offences relating to investigations

(1)A person commits an offence if the person—

(a)20intentionally obstructs an investigator in the performance of functions
conferred by section 104, or

(b)fails without reasonable excuse to comply with a notice given under
section 105.

(2)A person commits an offence if the person provides information to the HSSIB
25for the purposes of the HSSIB’s investigation function which the person knows
or suspects is false or misleading in a material respect.

(3)It is a defence for a person charged with an offence under subsection (2) to
show that—

(a)the person reasonably believed that the information would assist the
30HSSIB in carrying out its investigation function, and

(b)at the time of providing the information the person informed the HSSIB
that the person knew or suspected that it was false or misleading.

(4)If a person charged with an offence under subsection (2) relies on the defence
under subsection (3), and evidence is adduced which is sufficient to raise an
35issue with respect to that defence, the court must assume that the defence is
satisfied unless the prosecution proves beyond reasonable doubt that it is not.

(5)A person who commits an offence under this section is liable on summary
conviction to a fine.

(6)Subsections (1)(a) and (5) apply to persons in the public service of the Crown
40as they apply to other persons.

Protection of material held by the HSSIB

108 Prohibition on disclosure of HSSIB material

(1)The HSSIB, or an individual connected with the HSSIB, must not disclose
protected material to any person.

(2)5In this Part “protected material” means any information, document, equipment
or other item which—

(a)is held by the HSSIB, or an individual connected with the HSSIB, for the
purposes of the HSSIB’s investigation function,

(b)relates to a qualifying incident (whether or not investigated by the
10HSSIB), and

(c)has not already been lawfully made available to the public.

(3)In this Part “individual connected with the HSSIB” means—

(a)a member of the HSSIB,

(b)a member of a committee or sub-committee of the HSSIB,

(c)15an investigator, or

(d)an individual (other than an investigator) who works for the HSSIB.

(4)For the purposes of subsection (3)(d) an individual “works for” the HSSIB if the
individual works—

(a)under a contract of employment with the HSSIB,

(b)20under a contract of apprenticeship with the HSSIB,

(c)under a contract under which the individual undertakes to do or
perform personally any work or services for the HSSIB, or

(d)as an agency worker within the meaning of the Agency Workers
Regulations 2010 (S.I. 2010/93) in circumstances where the HSSIB is the
25hirer within the meaning of those Regulations.

(5)An individual who was, but has ceased to be, connected with the HSSIB must
not disclose to any person, other than the HSSIB or an individual connected
with the HSSIB, any information, document, equipment or other item held by
that individual—

(a)30which the individual obtained because they were connected with the
HSSIB,

(b)which, at the time they ceased to be connected with the HSSIB, was
protected material, and

(c)which has not already been lawfully made available to the public.

109 35Exceptions to prohibition on disclosure

(1)Section 108(1) does not apply to a disclosure which is required or authorised
by—

(a)Schedule 14,

(b)any other provision of this Part, or

(c)40regulations made by the Secretary of State.

(2)Regulations under subsection (1)(c) may, for example, require or authorise
disclosures of protected material by reference to—

(a)the kind of material that it is (for example, a particular kind of
equipment),

(b)the matters to which it relates,

(c)the person from whom it was obtained,

(d)the purpose for which it was produced or is held, or

(e)the purpose for which it is disclosed.

(3)5But regulations under subsection (1)(c) may not require or authorise
disclosures of protected material by reference to the qualifying incident to
which the material relates.

(4)Regulations under subsection (1)(c) may provide for a person to exercise a
discretion in dealing with any matter.

(5)10Subject to subsection (6), regulations under subsection (1)(c) may provide that
disclosures which are required or authorised by the regulations do not
breach—

(a)obligations of confidence owed by the person making the disclosure, or

(b)any other restrictions on disclosure.

(6)15Nothing in regulations under subsection (1)(c) operates to require or authorise
disclosures which would contravene the data protection legislation (but, for
the purposes of this subsection, in determining whether any disclosure
required or authorised by the regulations would do so, take the requirement or
authorisation into account).

110 20Offences of unlawful disclosure

(1)A person commits an offence if the person—

(a)breaches the prohibition in section 108(1) by knowingly or recklessly
disclosing protected material to another person, and

(b)knows or suspects that the disclosure is prohibited.

(2)25An individual who was, but has ceased to be, connected with the HSSIB
commits an offence if the individual—

(a)breaches the prohibition in section 108(5) by knowingly or recklessly
disclosing any information, document, equipment or other thing to
another person, and

(b)30knows or suspects that the disclosure is prohibited.

(3)Subsection (4) applies where protected material is disclosed to a person not
connected with the HSSIB—

(a)in a draft report sent to the person under section 101(1),

(b)under paragraph 2, 3 or 4 of Schedule 14 (disclosures for purposes of an
35investigation, offence or safety risk), or

(c)under regulations under section 109(1)(c).

(4)The person not connected with the HSSIB to whom protected material is
disclosed as specified in subsection (3) commits an offence if the person—

(a)knowingly or recklessly discloses the protected material to another
40person without reasonable excuse, and

(b)knows or suspects that it is protected material.

(5)A person who commits an offence under this section is liable on summary
conviction to a fine.

111 Restriction of statutory powers requiring disclosure

(1)A power under any enactment (whenever passed or made) other than this Part
to require the disclosure of, or to seize, any information, document, equipment
or other item may not be used—

(a)5to require the disclosure of protected material by the HSSIB, or

(b)to seize protected material from the HSSIB.

(2)Subsection (1) applies to a power to require disclosure, or to seize, however it
is expressed (and, for example, it applies if the power is to require a person to
give, supply, furnish or produce any information, document, equipment or
10other item).

(3)Subsection (1) does not apply to a power to the extent that the provision
conferring it is within the legislative competence of a devolved legislature.

(4)A provision is within the legislative competence of a devolved legislature if—

(a)it would be within the legislative competence of the Scottish Parliament
15if it were contained in an Act of that Parliament;

(b)it would be within the legislative competence of Senedd Cymru if it
were contained in an Act of the Senedd (including any provision that
could only be made with the consent of a Minister of the Crown);

(c)the provision, if it were contained in an Act of the Northern Ireland
20Assembly—

(i)would be within the legislative competence of that Assembly,
and

(ii)would not require the consent of the Secretary of State.

(5)In this section “enactment” includes an enactment comprised in subordinate
25legislation within the meaning of the Interpretation Act 1978.

(6)References to the HSSIB in subsection (1) include—

(a)an individual connected with the HSSIB, and

(b)an individual who was, but has ceased to be, connected with the HSSIB.

(7)This section is subject to paragraph 6 of Schedule 14 (disclosure to coroners).

30Relationship with other bodies

112 Co-operation

(1)This section applies where—

(a)the HSSIB is carrying out an investigation into a qualifying incident,
and

(b)35a listed person is also carrying out an investigation into the same or a
related incident.

(2)The HSSIB and the listed person must co-operate with each other regarding
practical arrangements for co-ordinating those investigations.

(3)The following are listed persons—

(a)40an NHS foundation trust, an NHS trust or any other person providing
NHS services;

(b)NHS England;

(c)an integrated care board;

(d)a Special Health Authority;

(e)the Care Quality Commission;

(f)the Health Research Authority;

(g)the Human Tissue Authority;

(h)5the Human Fertilisation and Embryology Authority;

(i)Health Education England;

(j)the Health Service Commissioner for England;

(k)the Parliamentary Commissioner for Administration;

(l)any regulatory body;

(m)10the Health and Safety Executive;

(n)the Commissioner for Patient Safety.

(4)The HSSIB must publish guidance about when a qualifying incident is to be
regarded as related to another incident for the purposes of this section.

(5)If the HSSIB revises the guidance the HSSIB must publish it as revised.

113 15Assistance of NHS bodies

(1)The HSSIB must comply with—

(a)any request by a relevant NHS body to provide it with assistance in
connection with the carrying out of investigations into incidents
occurring during the provision of NHS services or occurring at
20premises at which NHS services are provided;

(b)any request by NHS England to provide any other relevant NHS body
with such assistance;

(c)any request by the Secretary of State to provide a relevant NHS body
with such assistance.

(2)25In subsection (1) “relevant NHS body” means—

(a)an NHS foundation trust;

(b)an NHS trust;

(c)NHS England;

(d)an integrated care board.

(3)30For the purposes of this section giving assistance includes—

(a)disseminating information about best practice,

(b)developing standards to be adopted, and

(c)giving advice, guidance or training.

(4)Subsection (1) does not apply if—

(a)35the assistance requested is giving advice, guidance or training, and

(b)the HSSIB determines that it is impracticable for it to give the
assistance.

(5)The HSSIB may give assistance to a person other than a relevant NHS body in
relation to any matter connected with the carrying out of investigations if the
40HSSIB has been requested to provide the assistance by the person to whom it
is to be given.

(6)But the HSSIB may give assistance under subsection (5) only to the extent that
the assistance does not to any significant extent interfere with the exercise by
the HSSIB of its investigation function.