Download Medical Directorate ACCESS TO ELECTRONIC CARE RECORDS

Medical Directorate
ACCESS TO ELECTRONIC CARE
RECORDS (eCR) FOR NON TRUST
RESEARCHERS
WHEN A PATIENT HAS CONSENTED TO A
RESEARCH PROJECT
STANDARD OPERATING PROCEDURE NO
SOP 14
DATE RATIFIED
31st July 2015
NEXT REVIEW DATE
31st July 2017
POLICY STATEMENT/KEY OBJECTIVES:
This document outlines the procedure for a non-Trust researcher when they
need access to electronic patient notes
POLICY AUTHOR: Andrew Pennington, Associate Director or Research and
Development, Charlotte Bee; Research Operations Manager and Beverley
Lowe; Research Senior Officer
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BACKGROUND
Health records are important in modern healthcare. They have two main
functions:
Primary function
The primary function of healthcare records is to record important clinical
information, which may need to be accessed by the healthcare professionals
involved in a person’s care.
Information contained in health records includes:
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the treatments that person has received,
whether that person has any allergies,
whether the person is currently taking medication,
whether the person has previously had any adverse reactions to certain
medications,
whether the person has any chronic (long-lasting) health conditions,
such as diabetes or asthma,
the results of any health tests the person may have had, such as blood
pressure tests,
any lifestyle information that may be clinically relevant, such as whether
a person smokes, and
personal information, such as age and address
Secondary function of health records
Health records can be used to improve public health and the services
provided by the NHS, such as treatments for cancer or diabetes. Health
records can also be used:
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to determine how well a particular hospital or specialist unit is
performing,
to track the spread of, or risk factors for, a particular disease
(epidemiology), and
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in clinical research, to determine whether certain treatments are more
effective than others.
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Types of health record
Health records take many forms and can be on paper or electronic. Different
types of health record include:
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consultation notes, which the GP takes during an appointment,
hospital admission records, including the reason why a person was
admitted to hospital,
the treatment a person will receive and any other relevant clinical and
personal information,
hospital discharge records, which will include the results of treatment
and whether any follow-up appointments or care are required,
test results,
X-rays,
photographs, and
image slides, such as those produced by a magnetic resonance
imaging (MRI) or computerised tomography (CT) scanner
Confidentiality of health records
There are strict laws and regulations to ensure that health records are kept
confidential and can only be accessed by health professionals directly
involved in your care.
There are a number of different laws that relate to health records. The two
most important laws are:
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Data Protection Act (1998)
Human Rights Act (1998)
Computer Misuse Act (1990)
Under the terms of the Data Protection Act (1998), organisations such as the
NHS must ensure that any personal information it gathers in the course of its
work includes:
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only used for the stated purpose of gathering the information (which in
this case would be to ensure that you receive a good standard of
healthcare), and
kept secure
It is an offence to breach the Data Protection Act (1998) and doing so can
result in a monetary penalty.
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The Human Rights Act (1998) also states that everyone has the right to have
their private life respected. This includes the right to keep your health records
confidential.
The Computer Misuse Act covers breaches where personal information is
recorded electronically, and can result in criminal proceedings.
Important changes to health records
The NHS is currently making some important changes to how it will store and
use health records over the next few years.
In July 2013, the Strategic Systems and Technology Directorate
published “Safer Hospitals, Safer Wards: Achieving an integrated digital care
record” which sets out the pathway for NHS providers to move from paperbased record-keeping through “paper-light” to paperless systems. It covers all
areas of systems development including data standards, product sourcing,
skills development for staff and integration across care settings.
http://www.nhs.uk/NHSEngland/thenhs/records/healthrecords/Pages/overview
.aspx
http://www.england.nhs.uk/wp-content/uploads/2013/07/safer-hosp-saferwards.pdf
Lancashire Care NHS Foundation Trust has a system named eCR (electronic
care record) formally eCPA (electronic care plan approach) which has all the
Trusts patient notes. Access to eCR is only for relevant Trust staff, i.e.
clinicians who need to access their patients notes as well as some members
of the research department who may need to add to notes where a patient is
taking part in a research project. This access is not granted to every member
of staff and it is prohibited to review patient notes unless part of the direct
clinical team for that patient or appropriate authorisation is granted.
PURPOSE
This SOP is designed to describe procedures for non-Lancashire Care NHS
Foundation Trust staff researchers when they need to access patient’s
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medical notes, where a patient has consented for them to do so for a research
project, and this is outlined within the ethics application.
PROCEDURE
Who?
This SOP applies to a researcher who is not employed by the Trust, who
requires access to eCR.
When?
A researcher can only access patient notes if the patient has consented for
them to do so. There would be a consent form, which had received NHS
Ethical Approval and a copy of this consent form would be located in the
patients notes, with a blank copy of the consent form stored in the study
folder.
How?
A researcher must request permission to access the electronic patient notes
via the Research Department. This must be put in writing, with the following
details:
a) name of the research project
b) reason for requiring access to patient notes and which patient
groups
c) consent form version number that the patient consented with
d) name of the researcher(s) who would like to access the patient
notes
e) confirmation that the said researcher(s) have a letter of access
in place with the Trust
f) Number of patients notes they need to review
g) Timescale required to review the notes
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Following this request, the Research department would do the following
checks:
a) confirm that the research project has Trust permission and
Ethics approval in place
b) confirm that the consent form version number has received
Ethics approval
c) confirm that the researcher(s) are listed as being part of the
research team
a. either on the SSI application form
or, there CVs are stored in the study folder
d) confirm that the researcher(s) have letters of access in place
for the study and that these are in date
Once the above checks are in place, the Research Department will:
1. Email a letter to the researcher(s) for them to sign to confirm that they
will adhere to the conditions listed on the letter, whilst accessing
Lancashire Care eCR (see appendix 1)
2. Complete the IT New User Form (located on the Trust Internet page) to
set up a temporary IT account for the researcher(s)
3. Once the IT accounts have been set up, contact the researcher(s) and
ask them to complete the following:
a. Contact the IT Helpdesk on 01772 695316
b. Give them their name
c. Ask for a password reset
d. Give them a line manager name (Mike Fitzsimmons)
e. They will then be given details for the password reset
f. They are then able to login LCFT computers and eCR and
access the system, using the username:
[email protected] and password
4. Ask the researcher(s) to evidence they have completed Information
Governance (IG) training (as part of mandatory training if an NHS
employee of another Trust, or they have completed IG training with
their University employer) by sending a copy of the training certificate
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a. If the researcher cannot evidence they have completed IG
training, contact the IG Department
([email protected]) in order to set up
Information Governance Training and make the researcher(s)
aware exactly what they need to do and once completed to send
a copy of the training certificates to the Research department.
LCFT IT training will be completed through their LCFT IT
account
5. Following receipt of the signed letter (appendix 1), the Research
department needs to liaise with the researchers regarding booking
them onto eCR Blue training
http://lcftintranet/sites/IMTtraining/SitePages/Coursebooking.aspx
6. Once the researcher has completed eCR training the researcher is
then to contact the Research department to book a time/date to review
the notes or they can liaise with the clinical service where they
recruited their participants from to book time/date to review the notes
(under supervision)
o If taking place in the Research department, the desktop PC will
be booked for them and there must be a member of the
Research staff available to assist/supervise
7. Once the researcher does not require access to eCR anymore,
Research to contact the IT Helpdesk and request the account is
deactivated
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OTHER RELATED PROCEDURES, POLICIES, LEGISLATION OR
GUIDANCE
Information Governance Policy
APPENDICES
Appendix 1 – Letter template - Access to Lancashire Care Foundation
Trust (LCFT) electronic care records for non-LCFT researchers
A
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Appendix 1
Lancashire Care NHS Foundation Trust
Lantern Centre
Vicarage Lane
Fulwood
Preston
PR2 8DW
Tel: 01772 773498
[email protected]
Insert date
Access to Lancashire Care Foundation Trust (LCFT) electronic care records for nonLCFT researchers
Non-Trust staff requiring access to LCFT electronic care records for research purposes will be
granted access subject to being able to evidence:
1. Which LCFT patient group(s) are relevant to the study
2. That patients whose records will be accessed have
a. consented to the study
b. consented to their records being used by the researchers
3. That the researchers
a. Have completed Information Governance training (with their current
NHS/University employer or LCFT)
b. Have completed LCFT training in using the electronic care records system
c. Comply with all relevant Trust policies and procedures including the Information
Governance policy
d. Comply with the Department of Health Research Governance Framework and
ICH Good Clinical Practice Guidelines as appropriate
e. Inform Trust Research Department ([email protected]) when the
research data has been collected so that access can be deactivated
f. Understand that a breach of any of these assurances, Trust policies or SOP for
Access to Electronic Patient Notes will result in immediate withdrawal of access
and disciplinary and/or legal action may be taken against you
Signed by the researcher:
………………………………………………………………..
Print Name:
……………………………………………………………….
Date: ………………………………………………………
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