Information Governance Department

North Wing
St. Pancras Hospital
4. St. Pancras Way
London NW1 0PE
Tel: 020 3317 3115
Fax: 020 3317 3130
Information.Request@candi.nhs.uk

GUIDANCE IF PATIENTS WISHES TO OPT-OUT OF RIO ELECTRONIC CLINICAL RECORDS

These days most clinical records are now being held electronically and the Camden and Islington NHS
Foundation Trust has decided to use the Rio system to ensure that service user’s information is
immediately available online and the data can be transferred quickly and efficiently without the need for
manual records.

However under the Data Protection Act 1998 a service user has the right not to have their information
stored electronically. The minimum legal requirement is that the Trust keeps a paper clinical record in a
safe environment. However, the healthcare professional (HCP) can justify their decision to hold an
electronic record against the wishes of the patient if the patient poses a risk to themselves or the public.

To address these conflicting requirements, the Trust has developed this guidance to assist the process
that allows it to comply, wherever possible, with the wishes of the patient whilst enabling staff to access
information to provide care.

Process for healthcare professionals (HCPs)

The patient will usually initiate the process by discussing with their HCP they do not wish their clinical
information to be held electronically and their reasons. The HCP should try to resolve the issue by
discussing it with the patient providing the following reassurances in relation to the security of the system
and processes which are in place to ensure confidentiality.

HCP should inform the patient that only authorised members of staff can access the system, and only after
they have been trained and assessed. There are also access controls to ensure that staff has the
minimum required access in order to perform their duties.

That all staff is bound by a strict Confidentiality Code of Conduct which forms part of their terms of
employment. If staff is found not to have conformed to the Trust’s Confidentially Code of Conduct, they will
be subject to disciplinary action by their line manager.

An HCP should try as much as possible to allay the patient’s fears of everyone wanting to look at their
records. The electronic record ensures that clinical information is available 24 hours a day which greatly
reduces risk to the patient and is far more efficient than paper records. The patient should be made fully
aware of the risk that in an emergency their paper record may not be as readily available as would an
electronic record.
 If the patient refuses to allow any clinical information to be held electronically then the following steps
should be taken.

1. The HCP should confirm whether the patient has the capacity to make such a decision regarding
their clinical records. If the HCP is unsure a qualified consultant psychiatrist should be asked to
assess mental capacity of the patient.

2. The HCP should ascertain whether there are any particular factors of the patient’s information that
need to be held electronically e.g. where a patient poses a risk to the public or themselves and the
lack of readily available information would increase that risk. .

If the patient does have capacity and there are no compelling reasons why their wishes should be
disregarded then patient’s information can be held in a paper clinical record only. However, it will be
necessary to record the patient’s demographic information in RiO in order to track the whereabouts of their
paper record to ensure efficient retrieval and a note saying that the patient has a paper record only.

THE HCP should write to the patient attaching the Opt Out Form which the patient will need to sign. The
Opt Out Form should confirm that the patient accepts the risks and the reasonable delays in obtaining their
records.

The HCP must complete and carry out the steps described in the ‘Opt-out Form’ (see attached) and
forward to the Information Governance Manager, North Wing, St Pancras Hospital, 4 St Pancras Way,
London NW1 0PE together with a copy of the discussions and form (see attached) in order to complete the
process. If the HCP feels that the patient should have their records electronically, they have state this fully
so that the Information Governance Manager and the Caldicott Guardian are aware of the HCP’s decision

The minimum requirements for a patient who does not wish to have an electronic clinical record are as
follows:

1. A note on Rio stating that their record is held in a paper clinical record
2. That only their demographic information is held on RiO under a new RiO ID.
3. The location of the paper record is tracked on RiO to ensure efficient retrieval
4. The original RiO will be deleted by the back office.
5. To ensure that staff do not record clinical information electronically the following statement –

‘DO NOT ENTER CLINICAL INFORMATION FOR THIS PATIENT –

TO BE RECORDED IN THEIR CLINICAL PAPER RECORD ONLY ’
- must be sign-posted in the following RiO documents:

o Risk Assessment
o Progress notes (marked as a significant event)
o Care Plan
o Core Assessment (Part 2)
o Document Upload

The request to ‘opt out’ will also prevent the clinical paper record from being and teams are responsible for
managing the paper record locally until the record is no longer needed when it should be forwarded to the
Information Governance Office for filing offsite.
 APPENDIX A

OPT-OUT’ PROCESS

A patient requests to opt-out of having an

electronic clinical record

HCP* to assess whether the patient has – mental

capacity – or pose a risk of serious harm to
themselves or to others

HCP to discuss with the patient and provide

reassurances around security and confidentiality
controls in RiO and to explain the risks of not
having a readily available electronic record

If HCP approves the patient’s request to opt- If the HCP does NOT approve the
out patient’s request to opt-out

HCP to discuss the reasons with the patient

HCP to write to the patient about their findings and record in their RiO Care Plan (with
and enclosing an opt-out form (Appendix B) review date if any)

The patient must confirm agreement in writing

that they have noted and accepted the risks.
This must be filed in the patient’s paper record. HCP to complete the opt-out form (See
Appendix C) and forward this to the
Information Governance Manager to file.

HCP to follow and complete all sections of the

opt-out form (Appendix C) and return to the
Information Governance Manager for review with
all documentation of discussion and findings.

Information Governance Manager to forward HCP* = (Healthcare Professional)

Appendices B & C to the Caldicott Guardian for a
decision as to whether the request to opt-out is
accepted or declined based on clinical risk.
 Appendix B

Information Governance Department, North Wing, St. Pancras Hospital,

4. St. Pancras Way, London NW1 0PE
Tel: 020 3317 3115 Fax: 020 3317 3130
Email: byron.charlton@candi.nhs.uk

OPT-OUT OF CLINICAL DATA

Please return this form to your Healthcare Professional

Title: Surname/Family Name

_____________________ _____________________________________________________________

Forname(s):

_________________________________________________________________________

Address:

______________________________________________________________________________________

______________________________________________________________________________________

Postcode: Telephone No: Date of Birth (dd/mm/yy)

___________________ ______________________ ____________________

NHS number (if known)

What does it mean if my clinical record is not electronically based?

• Healthcare staff treating you may not be aware of your current medications in order to treat you safely and effectively.

• Healthcare staff treating you may not be made aware of current conditions and/or diagnoses leading to a delay or missed
opportunity for correct treatment

• Healthcare staff may not be aware of any allergies/adverse reactions to medications and may prescribe or administer a
drug/treatment with adverse consequences.

• I confirm that I wish my clinical information to be held in paper format only and I understand that only my demographic
information will be held electronically in order to track my paper record to ensure efficient retrieval.

Signature_____________________________________ Date:___________________
 APPENDIX C

OPT-OUT of electronic clinical records

This form is to be completed by the responsible Healthcare Professional:

Please
Name of Patient: ____________________________ DOB: ______________ circle
answers
RiO no: _________________

1 A discussion has taken place with the patient to reassure them of confidentiality, Y N
security measures and mechanisms in RiO
2 The risks of not having a readily available electronic clinical record have been Y N
explained to them.
3 The patient has the mental capacity to make this decision Y N

4 There are compelling reasons why this patient’s information must be held Y N
electronically. (If the answer to this is ‘yes’, complete the reasons for your
decision below – do not complete numbers 5 – 10, but sign and date below and
return to the Information Governance Manager/Caldicott Guardian).

5 The patient has confirmed in writing that they do not want their clinical information
held electronically and has noted accepted the risks (a copy of this is held in their Y N
paper record).
6 All existing clinical information on RiO has been printed off and is now held in the
patient’s paper and the original Y N

7 I have re-registered the patient on RiO entering their demographic information only Y N

Their new RiO no. is: ________________________

8 A statement has been entered in the patient’s new RiO record which states:
‘DO NOT ENTER CLINICAL INFORMATION IN RIO FOR THIS PATIENT – TO
BE RECORDED IN THEIR PAPER CLINICAL RECORD ONLY ’
This is now signposted in the following sections in RiO:-
- Risk Assessment Y N
- Progress Note (marked as a significant event)
- Care Plan

9 The paper clinical record has been tracked in RiO in the comments box – Y N
demographics page, RiO, to ensure efficient location and retrieval

10 It has been locally agreed that the paper clinical record must not be electronically Y N
scanned when due for archive and must remain on site and managed by the
responsible clinical team until the end of its retention period when it must be
forwarded to the Information Governance Manager for secure filing offsite.

Name of healthcare professional (print): Signature:

Role: Date:

In order for the opt-out process to be completed by ICT Dept, please send a copy of this form to:
The Information Governance Office, North Wing, St Pancras Hospital (marking it Confidential)
or via email byron.charlton@nhs.net

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