An Organisation-wide Document for the Management of Screening Procedures
NHS Trust
An Organisation-wide Document for the Management
of Screening Procedures
Version:
Ratified by:
Date ratified:
Name of originator/author:
Name of responsible committee/individual:
Name of executive lead:
Date issued:
Review date:
Target audience:
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An Organisation-wide Document for the Management of Screening Procedures
Contents
1
Introduction ............................................................................................................. 4
2
Purpose .................................................................................................................... 4
3
Explanation of Terms ............................................................................................... 5
4
Duties ....................................................................................................................... 5
4.1
4.2
4.3
Duties within the Organisation ............................................................................................... 5
Committees and Groups with Overarching Responsibilities .................................................. 6
Duties External to the Organisation........................................................................................ 6
5
Education and Training ............................................................................................ 6
6
Development and Content of Guidance for Specific Screening Procedures ........... 6
6.1
6.2
Screening Procedures Carried Out in the Organisation .......................................................... 7
Guidance for Specific Screening Procedures ......................................................................... 7
Minimum Content of Guidance for Specific Screening Procedures ........................ 7
7
7.1
7.2
7.3
7.4
7.5
7.6
7.7
Introduction and Purpose ....................................................................................................... 8
Explanation of Terms .............................................................................................................. 8
Duties ...................................................................................................................................... 8
Requesting the Screening Procedures .................................................................................... 8
Performing the Screening Procedure...................................................................................... 8
Communication of Screening Results ..................................................................................... 9
Taking Action on Screening Results ........................................................................................ 9
8
Equality Impact Assessment .................................................................................... 9
9
Monitoring Compliance with the Document ........................................................... 9
9.1
9.2
10
10.1
11
Process for Monitoring Compliance ....................................................................................... 9
Standards/Key Performance Indicators ................................................................................ 10
References .......................................................................................................... 10
Guidance from Other Organisations ..................................................................................... 10
Associated Documentation ................................................................................ 10
Appendix A - Template Document for the Management of Screening Procedures .... 11
Appendix B - Template Document for the Management of Specific Screening
Procedures .................................................................................................................... 16
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An Organisation-wide Document for the Management of Screening Procedures
Review and Amendment Log
Version No
Type of Change
Date
Description of change
V.2
Annual review
Mar 2012
Update to section 4 ‘Duties’
V.2
Amendment
Mar 2012
Update to document, especially sections 6 and
7, to match changes in reviewed standards –
focus on overarching and guidance for specific
screening procedures rather than local
processes
Update to format
contents page
including
automated
Please Note the Intention of this Document
This document has been developed with the aim of providing a model document template.
However, any documentation subsequently produced must follow its own rules and include details
of all the requirements set out in sections 1-10, where relevant. The organisation may use this
template and adapt it to reflect procedures within the organisation or alternatively use a document
already in existence. Whichever approach is used the organisation must ensure it is compliant with
the minimum requirements of the relevant National Health Service Litigation Authority (NHSLA) Risk
Management Standards.
a
To assist the organisation, areas have been identified in the margins where the section
within the template document relates to the minimum requirements for the criterion in the
relevant NHSLA Risk Management Standards.
It is important that the document should follow any pre-existing guidance within the organisation in
relation to style and format of documentation. Please note that a template document entitled An
Organisation-wide Document for the Development and Management of Procedural Documents can
be found on the NHSLA website which may provide the organisation with additional guidance.
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An Organisation-wide Document for the Management of Screening Procedures
1
Introduction
This section should outline the scope of the document in providing robust organisation-wide
guidance in relation to the development of local detailed protocols or standing operating
procedures to support the process of requesting, undertaking, verifying and communicating
the results of all screening procedures.
This strategic document will provide direction for the development of guidance for specific
screening procedures, which may be based on nationally agreed standards of measurement.
2
Purpose
Within this section an explanation should be given as to the intent of the document with
regard to enabling all staff to ensure that screening procedures undertaken within the
organisation are managed to minimise the risk to patients and to improve patient outcome
and quality of care.
This section should outline the objectives of the process/system being described and should
include direction as to the agreed processes for:
V.2

identifying and offering screening to all the eligible cohort;

identifying systems that are in place for the screening procedure;

identifying healthcare staff with the authority to authorise and proceed with the
screening procedure;

making sure that informed consent occurs, with the requirement for a verbal
discussion and the use of specific patient information, giving due consideration to
confidentiality and the specific needs of the patient;

having systems in place to make sure that the sample(s), where relevant, have been
taken, are correctly identified and labelled, prepared and transported to comply
with the agreed protocols/standing operating procedures (SOPs);

having a clear and agreed escalation policy with named leads to make sure that
samples/test results are followed up if there is insufficient information and a repeat
screen is required;

identifying when it is appropriate to request an acknowledgement from the
receiving laboratory for specific samples;

ensuring that screening results are received within agreed timeframes by the
appropriate individual or electronic system;

dissemination of the screening results, by telephone, paper or electronic means;

informing all patients who undergo a screening procedure of their results (including
screen negative or low risk results). Where the patient is pre-advised of the
expected timeframe for feedback of results they should be actively encouraged to
enquire when results are not received within agreed timeframes;

all patients who receive a screen positive result or high risk result to have access to
an appropriately trained healthcare professional to discuss options for further
management to make sure that action to be taken is timely;
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An Organisation-wide Document for the Management of Screening Procedures
3

recording the outcome and any subsequent follow up required; and

ensuring that all screening processes are the subject of effective systems of
monitoring, evaluation and review.
Explanation of Terms
This section should list and describe the meaning of the terms used within the context of the
document. For example:

Screening
Screening is a process of identifying apparently healthy people who may be at
increased risk of a disease or condition. They can then be offered information,
further tests and appropriate treatment to reduce their risk and/or any
complications arising from the disease or condition.

Standard operating procedures (SOPs)
A clear, step-by-step instruction of how to carry out agreed actions that promote
uniformity to help clarify and augment such processes. SOPs document the way
activities are to be performed to facilitate consistent conformance to requirements
and to support data quality. SOPs provide individuals with the information needed
to perform a job properly and consistently.
The following list is a guide only and is not exhaustive:
4

Media

Independent Contractors

Accredited Laboratories
Duties
Give a brief overview of the roles, responsibilities and accountabilities for the
implementation of the organisation’s process. This section should be a brief overview only
and the details of the process for managing this should be incorporated within later sections
of the document. The following list is a guide only and is not exhaustive:
4.1
Duties within the Organisation
Some example responsibilities have been identified below; however, these should
be considered within the context of the individual organisational structure.
Chief Executive
This section should state that the chief executive is ultimately accountable for the
implementation of this organisation-wide process.
Lead Clinician/Director
This section should describe the role of the lead clinician/director in the
development of organisation-wide and local procedural documents to manage the
risks associated with screening procedures. This may include ensuring that all
screening procedures are undertaken by authorised healthcare staff following
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An Organisation-wide Document for the Management of Screening Procedures
training where necessary; developing standard operating procedures or equivalent
protocols to an agreed organisational or national standard.
All Staff
This section should define the responsibilities of all staff. It should emphasise the
individual responsibilities of all staff in relation to complying with the objectives of
the organisation.
4.2
Committees and Groups with Overarching Responsibilities
Trust Board
For effective implementation of the Organisation-wide Document for the
Management of Screening Procedures there must be active support from the most
senior members of the organisation. Organisations should detail how the chief
executive and the nominated directors are to gain assurance that this document is
being implemented within the organisation. There must be effective cooperation at
all levels of the organisation in order for this process to be successful.
Reporting Committee
This section should describe the function of the committee or screening board in
relation to the overview of screening and the adherence to organisational and local
standards.
4.3
Duties External to the Organisation
The organisation should consider external bodies which have a role in the effective
management of the systems to provide and manage screening procedures.
Accredited Laboratories
External assurances required as part of contractual agreements.
Independent Contractors
External assurances required as part of contractual agreements.
5
Education and Training
This section should include the organisation’s requirements for the competency and ongoing
training and development of staff in relation to the screening procedures managed within
the organisation. This section could cross reference to the organisation’s training needs
analysis.
6
Development and Content of Guidance for Specific Screening Procedures
This section should provide an overview of the rationale and process for developing
guidance for specific diagnostic tests. The organisation is advised to carry out a baseline
assessment of the screening procedures undertaken within the service to determine the
focus of the specific guidance documents, this should be done in addition to the assessment
of risk of the screening procedures.
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An Organisation-wide Document for the Management of Screening Procedures
a
6.1
Screening Procedures Carried Out in the Organisation
This section should provide, or cross-reference to, a full list of all the screening
procedures carried out in the organisation.
b
6.2
Guidance for Specific Screening Procedures
This section should provide, or cross-reference to, a list of the guidance available for
different screening procedures. A list of screening procedure specific documents
available in the organisation could be included as an appendix to this overarching
document. The organisation should make sure that it prioritises the development of
guidance for those screening procedures assessed as high risk.
The organisation should ensure that it is not duplicating other work, either
nationally or locally (including checking against the local register/library of
procedural documents).
7
Minimum Content of Guidance for Specific Screening Procedures
This section will form the basis of the structure and content of the guidance for each specific
screening procedure. The headings and prompts could be provided as an appendix to the
overarching document to support the development of each specific piece of guidance. See
Appendix B.
This section should state what must be incorporated as a minimum in the documented
process for each specific screening procedure, for example:
V.2

adherence to standard operating procedures or equivalent protocols;

ensuring all eligible populations are identified and offered screening;

ensuring that all screening procedures are undertaken by authorised healthcare staff
following specified training where necessary;

where the use of a laboratory service is required that the information includes:

the recording of the correct patient details;

the request for the correct screening procedure;

the details of the appropriate healthcare staff member for return of the
screening result and subsequent action; and

failsafe procedures if a sample is incorrectly labelled or insufficient,
inappropriate or contaminated samples are received;

where a screening procedure does not require laboratory analysis that the
undertaking and outcome of this activity should be documented in the designated
media;

the process for recording the receipt of the screening result, the interpretation and
the subsequent management plan in the appropriate media;

how results are communicated to the patient and other appropriate healthcare staff
members;
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An Organisation-wide Document for the Management of Screening Procedures

ensuring that identified actions are taken and documented, and that the method of
communication is recorded, face to face contact, phone call, letter, email, fax, etc;

ensuring that robust systems are in place which involve the receipt and filing of
paper held records; and

the continuous performance management and monitoring of the screening
procedures ordered and the management of results.
7.1
Introduction and Purpose
For each screening procedure, give an overview of the rationale for the
development of specific guidance. This section may refer to the specific risks of that
screening procedure.
7.2
Explanation of Terms
This section should list and describe the meaning of the terms used within the
context of the screening procedure document.
7.3
Duties
This section should a brief overview of the roles and responsibilities of the
individuals who are involved in the process for the specific screening procedure.
The following list is a guide and is not exhaustive:
Healthcare Staff
This section should include the responsibilities of healthcare staff, by discipline/role,
that the organisation has identified are involved for all stages of the screening
procedure. This may include adherence to standing operating procedures or
equivalent protocols; requesting a screening procedure; and undertaking training as
required and agreed.
Administrative Staff
This section should include the role expected of administrative staff in the processes
surrounding screening procedures
c
g
7.4
Requesting the Screening Procedures
This section should state the process for requesting a specific screening procedure.
As a minimum this should include the levels of authority required to request the
procedure. This section should state how the request for a screening procedure is
recorded.
7.5
Performing the Screening Procedure
This section should outline the process for performing the screening procedure. This
section may cross-reference to Standard Operating Procedures. As a minimum this
should include levels of competency and authority required to undertake the
screening procedure.
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An Organisation-wide Document for the Management of Screening Procedures
d
7.6
This section should describe the processes in place to inform the patient and other
relevant healthcare staff of the results of the screening procedure, giving due
consideration to confidentiality, sensitivity of results and the specific needs of the
patient. This should also include the process for documenting this communication.
e
g
f
Communication of Screening Results
7.7

how the clinician treating the patient is informed of the result, including
timescales;

where the result is recorded;

how the interpretation of the result is recorded; and

how the patient is informed of the result, including timescales.
Taking Action on Screening Results
This section should state the actions to be taken by the clinician following the result
of the screening procedure. As a minimum this should include:
8

ensuring that identified actions, for example, referral and follow-up, are
documented;

if communication with other healthcare professionals is required; and

that the method of communication is recorded, face to face contact, phone
call, letter, email, fax, etc.
Equality Impact Assessment
The organisation should identify who will undertake the Equality Impact Assessment which is
required to consider the needs and assess the impact of this overarching document in
accordance with the Organisation-wide Document for the Development and Management of
Procedural Documents. The Equality Impact Assessment Tool found at Appendix E of the
Organisation-wide Document for the Development and Management of Procedural
Documents could be completed and form part of the body of the document, but as a
minimum a statement should be included within the document to demonstrate that an
Equality Impact Assessment has been carried out and that the document does not
discriminate, highlighting any areas of good practice or risk areas requiring attention.
h
9
Monitoring Compliance with the Document
9.1
Process for Monitoring Compliance
This section should identify how the organisation plans to monitor compliance with
the Organisation-wide Policy for the Management of Screening Procedures. As a
minimum it should include the review/monitoring of screening procedure-specific
documents against all the minimum requirements within the NHSLA Risk
Management Standards. The following list is a guide to issues which could be
considered within this section and should be added to where appropriate:
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
Who will perform the monitoring?

When will the monitoring be performed?
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An Organisation-wide Document for the Management of Screening Procedures
9.2

How are you going to monitor?

What will happen if any shortfalls are identified?

Where will the results of the monitoring be reported?

How will the resulting action plan be progressed and monitored?

How will learning take place?
Standards/Key Performance Indicators
This section could contain auditable standards and/or key performance indicators
(KPIs) which may assist the organisation in the process for monitoring compliance.
10
References
This section should contain the details of any reference materials reviewed in the
development of the procedural document.
Listed below are some useful sources of reference material:
11
10.1
Guidance from Other Organisations

Department of Health (2000) Second Report of the UK National Screening Committee

Department of Health (2007) Collaborative Commissioning of National Screening
Programmes

National Patient Safety Agency (NPSA) (2004) Right Patient Right Care

National Screening Programme Standards

UK National Screening Committee (2010) Managing Serious Incidents in the English
NHS National Screening Programmes
Associated Documentation
This section should provide a cross reference to any other related organisational procedural
document(s).
The following list is a guide only and is not exhaustive:
V.2

Patient identification

Consent

Patient information

Incident reporting
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An Organisation-wide Document for the Management of Screening Procedures
Appendix A - Template Document for the Management of Screening Procedures
NHS Trust
An Organisation-wide Document for the Management
of Screening Procedures
Version:
Ratified by:
Date ratified:
Name of originator/author:
Name of responsible committee/individual:
Name of executive lead:
Date issued:
Review date:
Target audience:
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An Organisation-wide Document for the Management of Screening Procedures
Contents
1
Introduction ........................................................................................................... 14
2
Purpose .................................................................................................................. 14
3
Explanation of Terms ............................................................................................. 14
4
Duties ..................................................................................................................... 14
4.1
4.2
4.3
Duties within the Organisation ............................................................................................. 14
Committees and Groups with Overarching Responsibilities ................................................ 14
Duties External to the Organisation...................................................................................... 14
5
Education and Training .......................................................................................... 14
6
Development and Content of Guidance for Specific Screening Procedures ......... 14
6.1
6.2
7
Screening Procedures Carried Out in the Organisation ........................................................ 14
Guidance for Specific Screening Procedures ........................................................................ 14
Minimum Content of Guidance for Specific Screening Procedures ...................... 14
7.1
7.2
7.3
7.4
7.5
7.6
7.7
Introduction and Purpose ..................................................................................................... 14
Explanation of Terms ............................................................................................................ 14
Duties .................................................................................................................................... 14
Requesting the Screening Procedures .................................................................................. 15
Performing the Screening Procedure.................................................................................... 15
Communication of Screening Results ................................................................................... 15
Taking Action on Screening Results ...................................................................................... 15
8
Equality Impact Assessment .................................................................................. 15
9
Monitoring Compliance with the Document ......................................................... 15
9.1
9.2
10
10.1
11
Process for Monitoring Compliance ..................................................................................... 15
Standards/Key Performance Indicators ................................................................................ 15
References .......................................................................................................... 15
Guidance from Other Organisations ..................................................................................... 15
Associated Documentation ................................................................................ 15
Appendix A
Procedures
Template Document for the Local Management of Screening
15
Appendix B
List of Applicable Screening Procedures............................................... 15
Appendix C
Checklist for the Review and Approval of Procedural Documents ...... 15
Appendix D
Version Control Sheet ........................................................................... 15
Appendix E
Plan for Dissemination .......................................................................... 15
Appendix F
Equality Impact Assessment Tool ......................................................... 15
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An Organisation-wide Document for the Management of Screening Procedures
Examples of the Checklist for the Review and Approval of Procedural Documents, Version Control
Sheet, Plan for Dissemination and the Equality Impact Assessment Tool can all be found within the
Organisation-wide Document for the Development and Management of Procedural Documents on
the NHSLA website.
Appendix B in the Organisation-wide Document for the Development and Management of Procedural
Documents contains a flowchart to assist with the process for the creation and implementation of
procedural documents.
Review and Amendment Log
Version No
V.2
Type of Change
Date
March 2012
Description of change
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An Organisation-wide Document for the Management of Screening Procedures
1
Introduction
2
Purpose
3
Explanation of Terms
4
Duties
4.1
Duties within the Organisation
4.2
Committees and Groups with Overarching Responsibilities
4.3
Duties External to the Organisation
5
Education and Training
6
Development and Content of Guidance for Specific Screening Procedures
7
V.2
6.1
Screening Procedures Carried Out in the Organisation
6.2
Guidance for Specific Screening Procedures
Minimum Content of Guidance for Specific Screening Procedures
7.1
Introduction and Purpose
7.2
Explanation of Terms
7.3
Duties
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An Organisation-wide Document for the Management of Screening Procedures
7.4
Requesting the Screening Procedures
7.5
Performing the Screening Procedure
7.6
Communication of Screening Results
7.7
Taking Action on Screening Results
8
Equality Impact Assessment
9
Monitoring Compliance with the Document
10
9.1
Process for Monitoring Compliance
9.2
Standards/Key Performance Indicators
References
10.1
11
V.2
Guidance from Other Organisations
Associated Documentation
Appendix A
Template Document for the Local Management of Screening Procedures
Appendix B
List of Applicable Screening Procedures
Appendix C
Checklist for the Review and Approval of Procedural Documents
Appendix D
Version Control Sheet
Appendix E
Plan for Dissemination
Appendix F
Equality Impact Assessment Tool
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An Organisation-wide Document for the Management of Screening Procedures
Appendix B - Template Document for the Management of Specific Screening
Procedures
NHS Trust
Document for the Management of
[insert name of specific screening procedure]
Version:
Ratified by:
Date ratified:
Name of originator/author:
Name of responsible committee/individual:
Date issued:
Review date:
Target audience:
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Contents
1
Introduction and Purpose ...................................................................................... 18
2
Explanation of Terms ............................................................................................. 18
3
Duties ..................................................................................................................... 18
4
Requesting the Screening Procedure .................................................................... 18
5
Performing the Screening Procedure .................................................................... 18
6
Communication of Screening Results .................................................................... 18
7
Taking Action on Screening Results ....................................................................... 18
Review and Amendment Log
Version No
V.2
Type of Change
Date
March 2012
Description of change
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An Organisation-wide Document for the Management of Screening Procedures
1
Introduction and Purpose
2
Explanation of Terms
3
Duties
4
Requesting the Screening Procedure
5
Performing the Screening Procedure
6
Communication of Screening Results
7
Taking Action on Screening Results
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