standards for clinical governance & risk management

Standards for Clinical Governance & Risk Management: Achieving safe and effective, patient-focused care and services Feedback on consultation

October 2005

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Contents 1 Introduction 3 2 Process 4 3 Summary of consultation responses 6 4 Main themes 8 5 Feedback from pilot visit 10 6 Outcomes/actions 12 7 Conclusion 13 8 Acknowledgements 14

List of tables/figures Table 1 Details of consultation events 4 Figure 1 Comments received by NHS Board area 6 Figure 2 Comments by category 7 Figure 3 Action by category 12

Appendices Appendix 1 Distribution list 15 Appendix 2 Comments and associated actions 16

Although we set high standards for our work, we accept that there will be improvements that we can make to the organisation and our publications. It is important that we know about any comments, or feedback you may have, as we can learn from them and improve future publications. If you have comments, or feedback about this report, you should send these to :

Clinical Governance & Risk Management Project Team NHS Quality Improvement Scotland Elliott House 8-10 Hillside Crescent Edinburgh EH7 5EA

e-mail : [email protected]

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1. Introduction Background The Standards for Clinical Governance & Risk Management were published in October 2005 following a 2½ year period of development. The Project Group which undertook this task was established in September 2003 and initially began work on revising the NHS Quality Improvement Scotland (NHS QIS) Generic Standards. The Draft Standards for Healthcare Governance: Working towards safe and effective, patient-focused care were issued for consultation in January 2004. The key message from this initial consultation exercise was that the standards had lost their clinical and patient focus and therefore the Project Group continued to revise the standards in an attempt to address these issues. Around this time HDL(2003) 29 was issued by the Scottish Executive Health Department (SEHD) which set out the decision to integrate the Generic Clinical Governance Standards with the Healthcare Risk Management Standards developed by the Clinical Negligence and Other Risks Indemnity Scheme (CNORIS). The resulting Draft Standards for Clinical Governance & Risk Management were issued for consultation in April 2005. Approach The consultation on the Draft Standards for Clinical Governance & Risk Management took place during April to June 2005. During this time a number of events were undertaken to obtain the widest possible range of views. These events included: 10 individual consultation meetings; a targeted mail out requesting comments on the document; a PDF version of the draft standards available on the NHS QIS website, with the facility to comment on line; and a pilot visit to NHS Grampian. Feedback A wealth of feedback on the draft standards and the assessment process was received from across Scotland, ranging from individual comments to comments representing particular organisations. All comments received were categorised and collated for presentation to the Clinical Governance and Risk Management Project Group which developed the standards. Each comment was considered by the Project Group until a consensus was reached as to the action to be taken. Changes were made to the draft standards based on the agreed actions and the resulting final standards were issued to the Project Group for final sign-off in August 2005. Outcome The Standards for Clinical Governance & Risk Management, published in October 2005, reflect many of the wide ranging comments received during the consultation period and we believe this valuable input has resulted in a more comprehensive, robust and objective set of standards. The standards are available on the NHS QIS website at: www.nhshealthquality.org

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2. Process Approximately 1000 copies of the draft standards were initially distributed to a targeted mailing list of NHS staff, members of the public and numerous voluntary and charitable organisations (see appendix 1). A further 1000 copies of the draft standards were distributed on request. An electronic version of the draft standards was available to download from the NHS QIS website and the facility to comment by completing an online comments form was also provided. Each copy of the draft standards was sent out with an accompanying comments form and detailed guidance on how to participate in the consultation process. In addition, individual consultation events were held in order to gain specific feedback from key groups on the draft standards. Further details of these consultation events are provided in table 1. Table 1 – Details of consultation events Title of meeting Chief Executives and Chairs of NHS Boards Chief Executives of Special Health Boards Directors of Nursing and Academic Heads Directors of Planning Directors of Public Health NHSScotland Clinical Governance Leads * Public Focus Groups Risk Managers Network Scottish Association of Medical Directors Scottish Executive Health Department Representatives * NHS QIS commissioned the Scottish Consumer Council to undertake focus groups to ascertain public views on the content of the Draft Standards for Clinical Governance & Risk Management. Four focus groups were held in Peebles, Edinburgh, Perth and Glasgow. A total of 30 members of the public who had no previous experience of clinical governance and risk management participated in the focus groups. The full report on the focus groups can be accessed at: www.nhshealthquality.org. Participants at each consultation event were issued with a copy of the Draft Standards for Clinical Governance & Risk Management prior to each meeting. Each meeting commenced with a general introductory presentation on the background to the development of the draft standards and the consultation process. Participants were then invited to discuss the draft standards document and in particular to focus on:

• the content, format, structure and general readability of the document;

• the standard statements – clarity/omissions?

• the rationales – do they support the standard statements?

• the criteria – relevance/clarity/omissions?

• any other general comments. During each meeting, comments were recorded and collated for presentation to the Project Group following the consultation period.

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In addition to these consultation events a pilot review visit was also conducted to:

• assess the measurability, achievability and applicability of the draft standards;

• test the peer review methodology and performance assessment scale;

• receive feedback from the pilot site on any issues and difficulties with the process including: evidence gathering; self-assessment questions; and the peer review programme.

The pilot visit to NHS Grampian was held on the 16 June 2005. Representatives of NHS Grampian completed a self-assessment framework prior to the pilot visit which comprised of the presentation of core evidence and written responses to a series of questions designed to evidence performance against the criteria which underpin the standards. The completed self-assessment submission was then analysed by NHS QIS. The analysis, completed self-assessment framework and supporting evidence were then distributed to the review team members prior to the review. This information was used by team members to focus discussion on specific issues during the pilot visit. During the pilot visit, a number of interviews were held with representatives from NHS Grampian in order to validate the information provided in the self-assessment framework. Following the pilot visit, a short report was produced to demonstrate the performance of NHS Grampian in relation to the Draft Standards for Clinical Governance & Risk Management. The report also included a section on learning points for NHS QIS gained during the pilot visit. These learning points are detailed in chapter 6 of this report. Following the end of all consultation the comments/feedback were collated into the following broad categories:

• General strengths or challenges about the document;

• General comments on introductory chapters preceding the standards;

• Comments on specific standards/rationale/criteria. The collated comments were presented to, and considered by the Project Group, at its meeting on 29 June 2005.

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3. Summary of consultation responses A total of 56 responses were received during the consultation period, ranging from individual responses to joint responses representing a particular organisation. A total of 440 specific comments were received from 25 different organisations throughout Scotland. 33% of comments related to the introductory paragraphs which precede the standards; 7% of comments were generally supportive of the document; 3% of comments related to the general challenges of the document; 21% of comments related directly to standard 1 and its associated rationale and criteria; 18% of comments related directly to standard 2 and its associated rationale and criteria; and 18% of comment related directly to standard 3 and its associated rational and criteria. Figure 1 provides a breakdown of the comments received, categorised by NHS Board area, and illustrates the geographical spread of comments received from across Scotland. Figure 1- Comments received by NHS Board area

Comments Received by NHS Board Area

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2 21 1

0 01

6

2

19

10

3 32

02468

10

1214161820

Greater G

lasgo

w

Argyll a

nd Clyd

e

Forth V

alley

Western

Isles

Highland

Orkney

Shetla

nd

Grampian

Taysid

eFife

Lothi

an

Borders

Dumfries a

nd G

allow

ay

Lana

rkshire

Ayrshir

e and Arra

nOthe

r

Figure 2 (overleaf) demonstrates the number of responses in each of the comments categories.

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Figure 2 – Comments by category

Comments by category

32

14

145

93

77 79

0

20

40

60

80

100

120

140

160

Generalstrengths

Generalchallenges

Comments onintro chapters

Comments onStandard 1

Comments onstandard 2

Comments onstandard 3

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4. Main themes The following sections detail the main themes of the feedback that was received during the consultation period. General feedback on the draft standards Strengths Challenges

• Clarity of purpose • Inconsistent terminology • Comprehensiveness • Vague and open to interpretation • Avoidance of duplication • Not fully contextualised • Clarity of language • Irregular layout/ordering • Multi-clausal standards/criteria

• Use of jargon/technical language Standard 1 General comments • A number of criteria are vague and open to interpretation. • A high proportion of criteria are not robustly measurable. • Criteria alternate between stating basic principles and setting essential requirements. • Create a separate sub-heading within the essential criteria for emergency/continuity

planning. • Significant scope to further mainstream Patient Focus and Public Involvement (PFPI)

principles and issues more strongly. • Language and terms employed need to be defined more tightly to avoid confusion or

ambiguity. Specific comments • Criteria 1a.3 / 1a.5 – These two criteria should be combined as they are essentially

asking for the same thing. • Criteria 1a.8 / 1a.9 - Requirements on health boards made within the Civil Contingencies

Act need to be incorporated within the emergency and continuity planning subsection. • Criteria 1a.8 / 1a.9 – Could these two criteria be streamlined and combined? • Criteria 1a.11 – Need to be more specific about when risk assessment systems are

reviewed rather than “periodically”. • Criteria 1b.3 – How are Boards to evidence and measure “on going improvement in the

health of the population” within the terms of these standards and any follow-up peer review process?

Standard 2 General comments • Sets out a significant suite of rights and entitlements for patients and the public. • The standard and criteria are often too aspirational in their scope and pitch. • A number of criteria suffer from being too vague and open to interpretation. • A high proportion of criteria are not robustly measurable. • Criteria alternate between stating basic principles and setting essential requirements. • Due to the operational, clinical focus of this standard, it may be a challenge to robustly

assess at Board level.

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• There may be cross-over and conflict between a number of the criteria and Performance Assessment Frameworks for each Board.

Specific comments • Criteria 2a.4 / 2a.6 – How are Special Health Boards going to evidence compliance with

these criteria? • Criteria 2b.1 to 2b.2 – Needs to be redrafted to respond and align to latest Scottish

Executive guidance. • Criteria 2b.1 – How are NHS Boards able to ensure “fair and equal access to …..

associated services” which are out with the umbrella of NHS provision? • Criteria 2c.1 – Need to add in internal staff communication. Standard 3 General comments • Should this standard be moved forward as the introductory standard? • A number of criteria suffer from being too vague and open to interpretation. • A high proportion of criteria are not robustly measurable. • Criteria alternate between stating basic principles and setting essential requirements. • Is a specific research governance sub-heading required? Specific comments • Standard Statement – Concern about the use of the word “confident” in the current media

environment surrounding NHSScotland. The word needs to be replaced with something like “assured” for example.

• Criteria 3a.4 – Need to specify what “other agencies” NHS Boards have to work with to deliver this requirement.

• Criteria 3a.5 – Could this criteria be incorporated into Criteria 3a.2? • Criteria 3b.1 – Needs to align to current public sector disclosure requirements. • Criteria 3c.1 – Need to add in internal communication and PFPI requirements. • Criteria 3e – Need to ensure all standards are compliant with Freedom of Information and

Data Protection legislation.

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5. Feedback from pilot visit A number of issues were identified during the pilot visit to NHS Grampian by members of the visiting review team and representatives of NHS Grampian who participated in the pilot review. These issues are detailed in the following sub-sections: Self-assessment issues • It would be useful to receive demographic profiles from NHS Boards prior to the review

visits. • There is a lack of public health focus throughout the self-assessment. • It would be useful to request examples of outcomes in core evidence requirements. • There was duplication of self-assessment questions, particularly in relation to PFPI. • There was a need to make linkages between PFPI and clinical governance. • The core evidence requirements need to be more focused. • It would be useful to provide a scenario within the self-assessment and ask NHS Boards

to track this through their system, eg response to NHS alerts/most recent NHS QIS reports, eg diabetes.

Evidence • Core documentation should be submitted separately from supplementary evidence. • If core evidence is not submitted an explanation of why this is not available should be

provided. • NHS Boards need to justify why any supplementary evidence has been included,

particularly where this is in place of core documentation. • Core evidence only should be disseminated to peer review teams. • It would be useful to target evidence to specific review team members based on their

individual area of expertise/interest. Analysis documentation • Analyst should consider provisionally allocating a performance assessment statement to

the analysis document – peer review teams will then validate this assessment during the peer review visit.

• Reviewers wish to receive analysis document at least 2 weeks prior to the review visit. • NHS Boards to receive analysis documentation prior to review (2 weeks). Boards could

be asked to submit any further documentation prior to team briefing meeting. Timelines • The project plan needs to be refined to suit this topic – evidence may require to be

submitted earlier to allow time to complete analysis. Peer review process • Substantial volume of evidence - difficult for review team members to digest all the

evidence in a short period of time. • Peer review team members to be allocated specific areas to review prior to the visit. This

will enable individuals to look at specific areas in more depth based on their area of expertise.

• NHS QIS needs to be more prescriptive re who attends meetings, eg Chair of Clinical Governance Committee/non-executives.

• Realign the visit programme.

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Performance assessment statements • NHS Boards could be asked to assess themselves against the performance assessment

statements prior to the peer review visit. Standards • Some vague criteria/open to interpretation • Some criteria not robustly measurable • Ensure consistency of terminology/definitions • Glossary needs to be refined eg. definition of a strategy. • Risk management definitions to be aligned with Australian/New Zealand risk

management standard definitions.

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6. Outcomes/actions All comments received on the Draft Standards for Clinical Governance & Risk Management, and feedback from the pilot visit were considered by members of the Clinical Governance and Risk Management Project Group during its meeting on 29 June 2005. The Project Group acknowledged the wide ranging comments received from a broad cross section of individuals and organisations with an interest and/or expertise in clinical governance and risk management. Each individual comment was considered by members of the Project Group until a consensus was reached as to the action to be taken. The following categories of actions were applied to each individual comment: • No action required; • Actioned – change made as suggested/described; • Noted – no action taken/comment redirected to appropriate level. Figure 3 indicates the percentage of actions within each of the category groups. Figure 3 – Action by category

Action by Category

10%

28%

62%

Not requiring actionTotal actioned

Total noted

A complete list of all comments received and the actions applied to each of these comments is provided in appendix 2. Following the project group meeting, the agreed changes were made to the Draft Standards for Clinical Governance & Risk Management and this revised document was sent out to members of the Project Group for official sign-off.

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7. Conclusion The valuable feedback on the Draft Standards for Clinical Governance & Risk Management and the assessment process received during the consultation period have helped to:

• inform the further development of the final standards; • refine the performance assessment methodology; • inform the project plan for clinical governance and risk management; • identify a comprehensive list of core evidence; • streamline the self-assessment framework; • identify the development of the peer review visit programme; • identify key individuals to participate in reviews; • and define a methodology that can be used by providers of direct and non-direct

clinical services. The resulting Standards for Clinical Governance & Risk Management: Achieving safe and effective, patient-focused care and services reflect many of the important issues raised by respondents during the consultation period.

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8. Acknowledgements Obtaining the views from a wide range of sources with an interest and expertise in clinical governance and risk management is considered to be a vital step in the process of standards development and has helped to ensure that these standards are comprehensive, robust and objective. This process would not have been possible without the participation of respondents during the consultation period and their input to this process is greatly appreciated. Particular thanks also goes to representatives of NHS Grampian who participated in the pilot visit.

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Appendix 1: Distribution list

Draft Standards for Clinical Governance and Risk Management

DISTRIBUTION LIST

NHS QIS Board Members NHS QIS Clinical Governance and Risk Management Project Group Members NHS QIS Primary Care Reference Group Members NHS QIS Liaison Co-ordinators Audit Scotland Directors of Social Work Disability Rights Commission Diversity Forums Health & Safety Executive Healthcare Commission Health Promotion contacts CHP/LHCC General Managers Local Health Councils Mental Welfare Commission NHS, Academic and Public Libraries NHS Board & Division Chairmen, Chief Executives, Medical Directors, Directors of Public

Health, Directors of Nursing, Directors of Planning, Chairs of Clinical Governance Committees, Directors of Finance and Directors of Human Resources (including Special Health Boards)

NHS NSS contacts (including Central Legal Office) Occupational Health Services Office of the Public Guardian Risk Managers’ Network Royal Colleges Scottish Commission for the Regulation of Care Scottish Consumer Council Scottish Executive Health Department Scottish Health Council Scottish Partnership Forum Scottish Public Services Ombudsman Voluntary Organisations

Appendix 2 – Comments and associated actions General Supportive Comments

• The draft allows improvement through learning. • There are many advantages of a comprehensive system of Clinical Governance and Risk

Management. • We commend you all on the content of the document, we are aware of how much work will have

gone into the creation of such a concise document, and the complexities of creating something that is required to span so many varying settings.

• The draft standards explain various levels of responsibilities very well. • The standards are welcomed in principal as a very necessary component of the Clinical

Governance agenda. • The purpose and scope of the draft standards is much clearer, being more defined and focused in

comparison to the previous Draft Standards. There has obviously been a considerable amount of work by the steering group and project team in reviewing these, resulting in an enhanced set of standards that more readily reflect the needs of the service.

• It is encouraging that these draft standards do not seek to duplicate standards and guidance from other organisations and that this is explicit within the document.

• The draft standards are clear, concise and potential links between this and other work of NHS QIS are apparent. The Standards Development Team is keen to work with colleagues to ensure the relationship between these, the topic specific standards and the quality assurance frameworks (QAF) developed by Managed Clinical Networks (MCNs) is clearly defined.

• The working party of NHS QIS who set up these standards are to be congratulated on achieving a clear set of standards. These standards should be widely consulted on and regularly reviewed and revised.

• On the whole I felt that this document is a clear statement for the standards expected of organisations dealing with clinical governance and risk management.

• As a whole the standards are easily transferable to the senior staff nurse considering her area of practice to the Chief Executive considering a Board area.

• The draft standards are a comprehensive, easily read document. • This document is more patient and carer friendly, more comprehensive and focused on the patient

experience. Also the document is very succinct and takes a positive approach to monitoring; being proactive rather than reactive.

• The overarching principals are significantly improved and much more relevant to the delivery of clinical services.

• Very user-friendly, easier to use with a comprehensive evidence base. • These standards are an improvement however still a little wordy. • The standards are straightforward and transparent in their aims. • NES welcomes the draft standards and applauds their presentation, which appears clear and

useable. • Overall the standards are clear. • The standards are comprehensive and accessible with clear criteria and evidence base. • Well written and systematic, providing a concise overview of CG and RM. • These standards are a vast improvement on the Healthcare Governance Standards issued last

year. • These standards look very comprehensive. • The document is much shorter than previous drafts which is an improvement. • The 46 criteria are wide ranging and will represent a challenge in terms of completing the self

assessment. • These are much better than the previous ones and can be interpreted at a local level to support

improved patient care. • Clear and concise with pleasant informal style. • Feedback to patients, public and staff from findings will encourage increased participation, overall

the standards will improve services. • Overall the 3 standards are clear, focused on determinants of safe, effective delivery and

maintenance of care. Easy to read, understandable and measurable. • Well written and comprehensive and bring clarity to complex areas. • It is much clearer what is required by NHS Boards and the volume of the standards is far more

realistic.

General Unsupportive Comments

• There is scepticism that this is merely another NHS paper exercise. • It is felt that NHS QIS must tackle time required for audit and inspection amongst and by staff, there is real

risk of inspection fatigue. • Even though there has been considerable effort put into audit and governance processes, this is often met

with sensationalist headlines in newspapers and elsewhere e.g. when the Scottish Audit of Surgical mortality

published infant mortality figures in Greenock. • In each case, (referring to each standard) the statements have more than one objective contained within

them, this means it becomes difficult to audit practice against the standard, as part of the standard statement may be being achieved and part may not. This will result in subjectivity in the results rather than being able to maintain objectivity.

• In order to support your statement within ‘Basic Principles’ that the standards are written in ‘simple language…’, throughout the essential criteria there is use of a considerable amount of ‘jargon’. This then appears to contradict your principle.

• Referring to all the standards, each point will be very difficult to audit because there are several points within each essential criteria point.

• In order to support your statement within ‘Basic Principles’ that the standards are written in ‘simple language…’ throughout the essential criteria there is use of a considerable amount of ‘jargon’. This then appears to contradict your principle.

• The primary area for concern is the lack of clarity and definition on how these standards relate to topic specific standards and the quality assurance frameworks developed by managed clinical networks. Clear strategic direction on this issue is necessary to ensure a cohesive approach to clinical governance is undertaken by NHS QIS, reducing confusion and duplication of effort within the service. The lack of defined approach is impacting on the progression of current work, such as the Asthma Services for Children, Blood Products and managed clinical networks projects.

• There are only 3 standards and we find this ‘broad brush’ approach concerning as CNORIS had 10 clinical and 10 non-clinical standards.

• Concerned that too much has been squeezed into too few standards. • The standards appear to have lost public health, and it is not apparent that it is intended that public health

activity should also meet the standards set out. • There is too much technical or managerial language through the document. • Standards lack patient perspective. • Concern that the delivery of health functions is not clearly identified in the detailed criteria.

General Comments on Text

General Comments Action • The issues of ‘CNORIS’ and ‘non-negligent harm’ both require a mention. Actioned - CNORIS

mentioned. • Appendix 2, Evidence Base (page 23 – 27): Should be amended to include

reference to EQIA, IEC and ‘Can I help you?’ guidance issued by SEHD since January this year.

Actioned - references added to appendix.

• Assessment of performance against the standards (Page 4): Should we not consider adding a fourth point in the Framework along the following lines, namely “This External Peer Review Process is ongoing and Interim Reviews may be undertaken if considered necessary.” This additional point may allay any fears in the eyes of the public that there is only ONE review carried out of the standards.

Actioned - added to final standards pg 7.

• Most of the background could go into an appendix. Actioned – background info revised and moved to appendix.

• Although it is recognised the Scottish Health Council (SHC) is newly established and evolving, it would be helpful to understand the role of the SHC in relation to these standards. This point has been raised due to the strong PFPI emphasis in Standard 2.

Actioned -reference to SHC included in final standards pg 11.

• The term ‘clinical governance’ and also ‘risk management’ both have a different definition in the introduction versus the glossary.

Actioned -definitions revised.

• Need to define terms more tightly. Actioned -definitions revised.

• Page 18 – standard statement deemed too stretching. Actioned – standard statement reworded.

• Need to ensure the same definition of risk management is consistently employed throughout the document.

Actioned -definitions revised.

• Page 18 – the use of the word ‘confidence’ in the Standard Statement is unhelpful and problematic. This is too open to interpretation and sways in public opinion.

Actioned – standard statement reworded.

• Useful to explicitly state on Page 9 which clinical governance themes are addressed in each standard.

Actioned – change made as suggested.

• The document is readable, however on page 9 the language used is difficult to understand and it needs to be clearer where different issues sit.

Actioned -wording revised.

• Using terms such as ‘good’ and ‘bad’ governance (see p.8) is inappropriate and not keeping with NHS QIS traditional house style.

Actioned -wording removed.

• Page 5 – Last sentence should read ‘these themes are under pinned by the need for effective systems …..’.


• Page 6 – The box with principals of good governance could be moved to the start of Section 3. Also delete the description of Risk Management as it is defined in the first paragraph and the glossary.

Actioned -changed as suggested.

• Page 8 – Second sentence replace ‘bad’ and replace ‘adversarial’ with ‘difficult’ thus allowing the addition of ‘adverse’ to events on the last line.


• Concern for NES that many of the Standards don’t apply due to not providing direct patient care.

Actioned -separate non-clinical self- assessment developed.

• Would be helpful if the standards were accompanied by good practice examples, which might assist in evidence collection and give the process an enhancement focus.

Actioned - good practice examples requested in self- assessment.

• No mention of review intervals – accreditation annual or 2-3 years? Actioned – see final standards pg 7.

• How are ‘peer reviews’ undertaken? Actioned - see final standards pg 7.

• Are users/carers to be involved in assessing quality? Actioned - lay representatives included in all review teams.

• Page 8 – The process that will be used to assess performance has not been clearly defined.

Actioned - see final standards pg 7.

• Page 9 – No mention has been made about the research governance framework.

Actioned -research governance included in standard 3.

• Page 11 – Could consideration be given to undertaking a pilot review visit in a large Health Board area?

Actioned - pilot visit undertaken in NHS Grampian.

• Perhaps not all the publications listed in Appendix 2 fall within the strict Actioned -title of

definition of evidence. Maybe create two sub-headings Reference and Evidence.

appendix changed.

• The definition of ‘information’ needs to be explicit and fully inclusive, ensuring that the term is not inappropriately restricted to ‘management data’. Perhaps provide footnote, or alternatively add ‘and knowledge support’ to the term ‘information’.

Actioned - definition revised.

• The national strategic and policy frameworks for NHS Scotland Knowledge Services should be referenced in Appendix 2 (evidence base). The relevant documents are: a.) Exploiting the Power of Knowledge in NHS Scotland: a national strategy. NHS Education for Scotland, 2004. b) From Knowing to Doing: transforming knowledge into practice in NHS Scotland. Draft for consultation. NHS Education for Scotland, 2005.

Actioned – reference to Knowledge Services Framework included in self-assessment.

• Page 6 (text box) – Definition relates more to RM process that RM itself. Perhaps start with AU/NZS 4360 definition of RM, followed by AU/NZS 4360 definition of RM process. Ensures consistency with AU/NZS Standard.

Actioned - text box removed, wording revised.

• Accuracy of AU/NZS 4360 needs checked as in document referred to as ‘standards’ but appears to be a ‘standard’.

Actioned – changed as suggested.

• Page 7 - Definition of ‘treatment plan’ different than the definition given on page 32.

Actioned - definitions revised.

• Glossary Page 32 – The definitions provided for ‘risk’, ‘risk assessment’ and ‘risk management’ are not the same as those provided by the AU/NZS 4360 Standard.


• Page 6 – Risk management statement could read ‘Patients, families, staff and the organisation’.


• Page 12 - The ‘D’ in Draft Standards….. should be in italics. The ‘challenge discrimination’ and ‘respect human rights’ bullets are expected regardless.


• Page 23-28 This evidence list could be more accurately termed the Reference list.

Actioned - title of appendix revised.

• Section 3- Title suggests two parts but there is a third heading. There is also confusion in the text as to the whole structure of governance. Elements of governance which are QIS remit and identify which organisation/s are responsible for the remaining elements.

Actioned - heading and structure revised in final standards.

• Page 5 – not clear from this section how Healthcare governance and Clinical governance fit together. For consistency, continuity and clarity suggest it might

Actioned -chapter revised.

be useful to use the definition of Clinical Governance from the NHS QIS website.

• Page 7 – The last two paragraphs and diagram could do with being under a different heading.

Actioned -chapter revised, RM diagram moved to appendix.

• Appendix 2 – Reference 28 – might be appropriate to reference this in Section 3. As with the others it might be useful to have the references grouped into the areas/issue they refer to.

Actioned – referencing revised in final standards.

• Appendix 4 – the definition of Clinical Governance is different to that in the text and different to other NHS QIS documents. Need consistency.


• Glossary – ‘informed consent’ is not in the text. Actioned –glossary item removed.

• It would be helpful to provide an index of policies/protocols/guidelines etc that may be required.

Actioned – list of evidence requirements included in self-assessment.

• Standards concentrate on negatives aspects of care i.e. threats and weaknesses. Should also be opportunity to comments on positive aspects e.g. strength and opportunities.


• Page 8 - Are the Faculty of Public Health Standards taken into account in regard to the public health function reference in this document?

Actioned - public health reference revised – see final standards pg 8.

• Page 9 - Why are HAI and food & nutrition singled out as governance issues? Actioned - reference to HAI & FFN removed.

• Page 8 –We (NHS QIS) emphasize that the clinical outcome indicators are produced to prompt further investigation at service level and should not be used externally, yet ‘outcome indicators…will be used to assess performance’ goes ahead and does this.

Actioned - reference to outcome indicators removed.

• Introductory section uses buzz words making it more difficult to read. Actioned – plain English check performed on final standards.

• Page 12 is clearest and has the most effective description of what the standards are therefore should come at the start of the introduction to CG.

Actioned – chapter order revised in final standards.

• Has the Scottish Health Council (SHC) got any responsibility/role within NHS QIS for the CG standards and review of practice against these standards?

Actioned - reference to SHC included in final

standards pg 11. • Page 5 – Themes are not helpful and don’t relate to anything else in document. Actioned - themes

removed. • Move Section 3 to start and have a more focused explanation of the CG and RM

concepts. Then follow this with concise description of how the standards were developed.

Actioned - order of introductory sections revised.

• There is repetition of some of the Overarching Principals in document, are they all needed.

Actioned – overarching principles and wrap around text revised.

• Page 7 – diagram not helpful. Actioned - RM diagram moved to appendix.

• May not be easily understood by lay people and includes jargon.

Actioned – plain English check performed on final standards.

• Page 4 – Useful to mention the involvement of the lay members. Actioned - changed as suggested.

• Mention needs to be made of the Scottish Health Council and our role in setting national standards for patient focus and public involvement and monitoring their implementation.

Actioned - reference to SHC included in final standards pg 11.

• ‘The Purpose of the Draft Standards’ (Page 8): This is an essential paragraph, however consider the wording of the line ‘…good clinical governance encourages public trust…….services to improve.’ This suggests that it is the public trust that ultimately improves the service, and not the adoption of governance.

Actioned - wording removed/revised.

• Page 5, section 3: 4th paragraph and 2nd sentence – why is this being stated here?

Actioned - wording removed see final standards pg 8.

• ‘The Purpose of the Draft Standards’ (Page 8): with reference to ‘bad governance’, this is a statement that may lead to confusion and concern, as it suggests that some areas may be receiving ‘bad governance’ input (and what exactly is that?) compared to other areas. If it is felt that a comparison should be made between successes of governance e.g. compliance and non-compliance, it would be a far more acceptable option to avoid use of terms such as ‘good’ and ‘bad’, as use of these terms could be considered judgmental.

Actioned - wording removed/revised.

• Generally, this paragraph should be shortened to state that adoption of Actioned - wording

governance will lead to the successes in patient care that are alluded to within the document.

revised & shortened.

• Page 9: 1st paragraph 2nd sentence – is this necessary? Actioned -wording removed.

• Page 9: 2nd paragraph 1st sentence – suggest that other stand alone standards are introduced and content of such added into an appendix.

Actioned - wording removed.

• Overreaching Principles (Page 12): -At points 2 and 3 in the "Box” should we not include and their ‘relatives/representatives’ after patients as some patients may be handicapped in some way.

-At point 4 do we actually need the word "appropriately” as it appears to me to be too vague. It would seem preferable for the item to read," support the provision of services to meet individual needs, preferences, and choices”.

Actioned - carers added – see final standards pg 12. Noted – no action taken.

• Risk Management (Page 7): I would prefer to see the last line read ‘control and minimise’.

Noted - RM diagram moved to appendix.

• ‘The health and care experience’ standard is focused on patients and carers. What about the implications for staff?

Noted- staff issues covered by staff governance standard.

• Page 7: The Note wording states ‘…. equally be defined as ‘control’. Reader acceptance may be greater if this statement suggested ‘manage’ rather than ‘control’. Also, in order to ensure clarity at this point reference should be made to the HSG 65 ‘POPIMAR’ model, to demonstrate the intrinsic links between the two models and approaches.

Noted - RM diagram moved to appendix.

• Will the issues of privacy and dignity be included in care experience category also the issues of mixed sex accommodation.

Noted - privacy & dignity issues mentioned on pg 10 also included in self- assessment.

• The ‘Assurance and Accountability’ standard is very wide ranging. Will the self-assessment framework define the range of clinical governance ‘arrangements’ which should be in place?

Noted - self-assessment will include evidence requirements.

• The purpose is not clearly stated on the front of it – could do with an initial objective statement plus brief explanation of what the reader is about to get to help orientation and guide the reader through better.

Noted - changes to introductory text made.

• The criteria laid out are clear, however in some instances it would be beneficial Noted - evidence

for some statement on how they should be evidenced. requirements included in self-assessment.

• By having several points within each essential criteria statement, the results cannot be valid when it comes to comparison across areas using results, as one area may have scored successfully based upon the achievements of different parts contained within each of the essential criteria points. For the same reason, the results are difficult to use within an organisation, as they cannot be sure then which of the points contained within the essential criteria statements they achieved in previous audits/reviews.

Noted – some changes to criteria made.

• There is no reference to Managed Clinical Networks (MCNs) within the document and the role of these should be considered. The current requirements of a quality assurance framework appear to duplicate some aspects of the draft standards whilst not including others such as risk management. It may be a more effective and efficient approach for MCNs to be included within the review of governance arrangements at an operational level and not include these issues within the QAF. The resulting QAF’s could then have a more clinical focus, which anecdotal feedback from the service has indicated would be preferable.

Noted – comment redirected.

• A significant proportion of the criteria are multi-clausal. If the grading system of Met, Not Met and Not Met – Insufficient Evidence is used, as is usual practice within NHS QIS, the multi-clausal nature of the criteria would make it difficult to make judgments on whether a criterion had been met or not. This may be less of an issue if a different grading system is planned in this case.

Noted - different system of assessment is to be used.

• The standards and criteria appear relevant, although many are not specific in terms of their quality of the standard i.e. criteria state ‘systems are in place’ however it is not clear how the effectiveness of these systems will be measured.

Noted - effectiveness of systems measured through review process.

• Within this section it is noted that governance arrangements at an operational level will be assessed using the NHS QIS condition and service specific standards. Although it is recognised the specific operational aspects of this have yet to be decided, there is no mention of how the operational governance arrangements will be quality assured for services that do not have topic specific standards. As all of NHS QIS topic specific work is in line with the national priorities, there is an argument that there is a higher risk of potential governance issues being missed in areas with these priorities if not included within any review process.


• The status of the Healthcare Associated Infection standards and the Food, Fluid and Nutritional Care in Hospitals standards in relation to the Draft Standards for Clinical Governance and Risk Management is clear. Further clarification on the relationship between other topic-specific standards and these draft standards is required to avoid confusion, primarily within the service. This raises 2 issues: -The relationship with existing topic-specific standards, the majority of which have some “governance” standards included within them. Therefore there is likely to be some duplication for the service, until the existing standards are reviewed and revised. -The relationship with new topic-specific standards. It remains unclear specifically how these will link and is appreciated that as a result, this cannot be detailed within the draft standards. It is an important organisational issue to be clarified to enable this to be included within the final standards and inform progress of current topic-specific standards that are currently under development.


• How will this strategy link in with the work of the new Social work and Inspection agency? How will the standards be applied in terms of Joint Services agenda?


• There is no mention of MCNs. Perhaps link the works of these with the standards?


• Several of the essential criteria are vague – what kind of evidence is required and how will it be evaluated?

Noted – evidence requirement included in self-assessment.

• Need to ensure that confusion around the term ‘healthcare governance ‘is disposed of as soon as possible.

Noted – definition of healthcare governance revised.

• Needs to be an emphasis on partnership with Local authority/voluntary bodies. Noted – reference to working with other agencies throughout final standards.

• Why Clinical Governance when everyone is now using Healthcare Governance. Noted - explained in chapter 3.

• No mention of links to training – these should be made explicit and linked to staff appraisal and development.

Noted – links to training included in staff governance standard.

• Will performance be reviewed against the draft standards, or only in relation to Noted – wording of

the finalised standards? Page 8 suggests the former while page 9 suggests later.

introductory sections revised.

• Should there be more about assessing against AU/NZS standard? His would be a good way of evidencing how well service is going.

Noted – assessment against AU/NZS standards covered in self-assessment.

• Page 8 – No patient or carer input in Project group.

Noted – there was lay representation on Project Group.

• Perhaps, by generalising the standard statements has led to a difficulty in defining what the achievements would be in order to support achievement of the essential criteria. This generalisation has an obvious impact upon the difficulty then in defining clear essential criteria. It is, in our opinion that in some situations standards need to reflect the complexity of the evidence required in order to then have the relevant merit associated with the achievement of the standard. This will obviously result in more standards, but will be a far more comprehensive tool that will support successful and objective self-assessment and peer review episodes and create results that can be used as accurate baselines in order to plot successes within organisations.

Noted – no action taken.

• Page 3, section 2 (Development of Clinical Standards). Why just clinical standards? Clinical Services cannot function without Non-Clinical Services.


• Page 4, section 2 (Development of Clinical Standards). Assessment of performance against the standards – should we have a time frame added.


• It would be useful to clarify if the term ‘evidence base’ refers to clinical and cost-effectiveness evidence.


• Page 8, section 4: a diagram may help in showing staff/public how the standards are developed.


• The Overarching Principles – bullet point 1, 2, 7 and 8 overlap. These could be drawn into two statements.


• Not sure how some of the criteria can be measured without qualitative research e.g. response to carers needs.


• Page 18, Rationale - Should also recognise in the rationale that Boards also have financial disciplines to comply with so public confidence in service levels includes provision of services within a cash limit.


• (Comments as of Standard 3) Difficultly with the references – these are to all SE Noted – no action taken.

or SEHD documents – unsure that the sources qualify as evidence. Rather looks like we are developing standards to require Boards to comply with SEHD/SE policy statements.

• It would be helpful to mention the non-clinical aspects, such as Knowledge/Library Services, of the work of NHS Boards. It is useful to have the public health function of NHS Boards noted in this section. Clinical governance encompasses such services within NHS Boards, but these can be overlooked.


• We appreciate that public consultation is beginning to take place but more publicity needs to be given to the various forums available for the public to participate in.


• The statements and criteria appear simple, but are actually complex when you look more closely at them.


• More needs to be said about the link / relationship between CG and RM. Currently this is not spelt out, merely assumed. A diagram / schematic could be used to best illustrate the connection in the document.


• More patient focused in its approach, emphasis and wording. Noted – no action taken. • Some of the statements and criteria are not specific. Noted – no action taken. • The emphasis on the development of contingency plans is welcomed as the

same standard of service is expected irrespective of difficulties faced by providers. The contingency plans should be built in to the governance procedures.


• It would be useful to include a paragraph stating who will be responsible for covering the other elements of governance not included in the standards.


• Mention of adverse events but not near misses. Noted – no action taken. • Page 14 – The governance around clinical decision making is unclear. It would

be reasonable to ask for evidence of audit of clinical decision making e.g. Suicide Reviews and Peer Discussion cases. Needs to be made more transparent and open to question.


• Welcome that RM and CG are combined. Need to link with other requirements to ensure that they are completely joined up e.g. PAF, Local Health Planning.


• The standards are very patient focused and will be challenging e.g. 2a.3. Noted – no action taken. • Whilst patient outcomes are core, the staff and organisational perspectives need

to be considered. Noted – no action taken.

• Do these standards have an evaluation date or are they always open to Noted – no action taken.

change? • Page 5 – Need more emphasis on ensuring organisations include RM and CG

into their learning plans. Noted – no action taken.

• Consideration needs to be given to those with speech, language and communication needs. Sufficient time may be required to communicate and respond depending on clients needs.


• Top-down approach unfortunate, could lead to the exclusion of aspects of clinical effectiveness, such as sharing base practice.


• What constitutes fair and equal access and do we know how to make it happen. Noted – no action taken. • Page 3 - Beneficial to highlight that standards are applicable to both the public

and private sector. Noted – no action taken.

• Page 14 – Standard 1 still very broad possibly written more from a top-down approach.


• Section 2 – The section on Access etc refers to strategy and systems; the section on Equality to systems only, and the section on Communication to strategy only. Could be perceived as an inconsistency in approach to the Standards.


• Appendix 1 – 3 representing the public out of 27 seems a bit low especially in view of the Patient Focus aspect of CG.


• Some language is ambiguous and terminology is not consistent throughout the document. Words that are subjective and open to interpretation include - periodically, robust, strategic, resilience, prioritise, dignity, and as necessary.

Noted –no action taken.

• It would be helpful to have guidance on who/how etc when talking about approving/coordinating/prioritizing.


• Page 12 Overarching Principals - Need reference to empowering staff to manage own information and learning needs rather than being solely passive recipients.


• Page 12 Bullet 3 What say do patients have, are they executive partners in their own care? Does the fourth bullet require ‘within current resource constraints? Does the last bullet mean ‘equity’ rather than ‘equality’ as equality of health even if achievable would lead to unequal allocation.


• If the standards are to have meaningful impact then there needs to be a much clearer explanation of how they should be used.


• The CG standards are set at a strategic level and the topic specific standards at Noted – no action taken.

an operational level (Page 8) – what does this mean in terms of the way they are set and reviews carried out?

• Page 5 – definition of CG to state what the patients and public are ‘involved’ in. Mention the interest of the patient should be at the centre and come first.


• Research governance and Information governance are specifically covered later in the document but it would be helpful to mention them earlier, perhaps page 9 where the links are made with other standards.


• These standards subsume PAF processes for PFPI, need to reinstate some elements i.e. ensuring the involvement of patients, carers and members of the public in options development and decision making processes; and that Boards can evidence involving partners, patients, carers and the public in developing objectives and strategies.


• Information is provided at a strategic level and it is not clear how the assessment process for the NHS Boards and service areas will be applied and how compliance will be measured at local level.


• Should be more emphasis on ensuring organisations include risk management and governance issues in their learning plans.


• It needs to be made clear who the standards are aimed at. It reads like a local not a national standards document.


• There is no mention of the timeliness of the data – real time data is now essential.


• The Overarching Principals seem to relate more to local rather than national level. Need to clarify this.


• Page 12 Suggested addition to overarching principals: ‘Are consistent with a value for money approach to financial resourcing and with considerations of workforce capacity’.


• In the introduction it is worth making reference to new ways of working to deliver new and improved services.


• The dimension of how the proposed solutions will impact on the workforce needs to be included. Workforce planning is not explicitly referenced.


• Need to ensure these standards measure local leadership, ownership and involvement which will support, encourage and assist staff to do their jobs well.


• The standards stray away from Communications strategy and performance management. Although these are dealt with through PAF there needs to be


clear demarcation of responsibilities. • Performance Management included within each standard (currently its only

included against Standard 3) and monitoring in itself is pointless unless the quality loop is closed, i.e. linked to remedial action when standards fall short of what they should be.


• In regards to commission care – need to make clear who is accountable and need to have means in place to measure the quality of this care.


• With jointly managed services how are the standards going to stop ‘passing the buck?’ with accountability and responsibility.


• Page 3 – what does ‘achievable and stretching’ mean in terms of the level at which the standards are set.


• There appears to be a focus on public involvement rather than patient focus.


• Main title may not be understood – perhaps make the subheading ‘Achieving safe… ‘ the main title.


• A suggested process to involve patients and the public in the standards could be as follows:

o patients and carers are involved in shaping and developing standards through focus groups, face to face and telephone interviews, questionnaires etc

o patients and carers are invited to comment on draft standards and this engagement process is supported by NHS QIS

o the views of patients and carers on their experience of the service under review are sought prior to the NHS QIS review visits through a range of formal and informal mechanisms

o the views of recent (within the last 2 years) patients and their carers / families contribute to the peer review visits

o training and support is provided to patients and carers to ensure they have the relevant information, skills and confidence to participate

o this process could be undertaken in partnership with local NHS staff in each area under review together with local and national voluntary organisations whose staff may be willing to consider development and capacity building in tandem with the work on developing the standards. This could result in lasting benefits for patients and carers such as patient and carer support groups, community transport


initiatives, information resources and training for volunteers. • Need more than four focus groups as not adequate given importance of

standards.


Comments on Specific Standards and Criteria

Comment Action Standard 1

Rationale

• The second sentence in the first paragraph refers to there needing to be, for members of the public, ‘an opportunity to contribute to this process’ (learning from experience). This does not adequately reflect the imperative attached to PFPI and the references cited in the appendix to the draft standards, as well as some of the more recent policy guidance issued.

It is recommended that in order to do this, the sentence be redrafted to read:

“… and patients and members of the public are permanent partners in contributing to this process.”

• Could benefit from rewording. Remove ‘all’ from first sentence and alter second paragraph to read ‘The review of clinical practice through e.g. audit and research…’.

• Possibly spilt into three sub-headings 1a Risk Management,

1b Emergency/Continuity Planning, 1c Clinical Effectiveness.

• The criterion is not clear on whether the ‘strategic objectives’

are the organisations overall strategic objectives or the organisations strategic risk management objectives.

• Criterion not clear as to whether action plans themselves

should be prioritised, or risks should be prioritised to ascertain whether action plans are required.

• Should include statement similar to Northern Ireland

Statements to bring in patient focus i.e. ‘avoiding injury and harm to service users, from the treatment and care that is intended to help them, is an integral part of high quality care’


Actioned – wording changed as suggested.

Actioned – wording changed as suggested.




Actioned - change made as suggested.

This shows how patients and public play a part in the detection and prevention of adverse events.

• Reword first statement to ‘views of patients, carers and

member of the public are actively elicited through a continuous process of involvement’.

• Suggest standard statement should read ‘…and based on

best available evidence’.



1a.1

• Maybe consider the sequence.

• More detail required on ‘open and responsive approach to

risk management’. • A definition of ‘unacceptable risk’ is required – could be

referenced to AU/NZ risk management standards risk matrix.

• Could read ‘demonstrable’ or ‘tangible’ open and responsive

approach to risk management.

• Could be part of rationale or combined with 1a.2.

• Change ‘responsive’ to ‘effective’.

• Need to mention about open culture within organisation.

Actioned - sequence changed. Actioned – more detail included in self-assessment.

Actioned – definition added.



Noted – no action taken. Noted – no action taken.

1a.2 • This statement could be open to interpretation.

• Add to rationale? • Clarify ‘operational framework’.



Noted – no action taken. 1a.3 • Two issues that should be split (strategic objectives and an Actioned – criterion

operational framework).

• In order that patient views and experiences are taken into account in the planning and delivery of services it will be essential for PFPI to be introduced at the earliest possible stage. In this particular criterion, the need for involvement of patients and the public should be made explicit.

It is therefore recommended that this criteria be redrafted to read: “potential threats and weaknesses in systems are identified at strategic and operational levels and an assessment of their impact undertaken, in partnership with patient/public fora.”

• Should include some form of action following assessment of impact.

• What is meant by ‘systems’. • As well as measuring strengths and weaknesses isn’t there

also need for robust and measurable evidence of the active safeguarding of services, patients and staff?

reworded.


Actioned – criterion reworded to reflect comment.



1a.4 • Two issues that should be split. Part of this is also contained within 1a.1.

• Should read ‘…to create a framework for reporting analysis,

review and feedback’.

• Not sure what ‘controls options’ are but it may seem more appropriate to evaluate all of these throughout the organisation.

• Wording could be shortened and simplified.




Noted – criterion reworded.

• What about complaints, claims and feedback.

Noted - included in self- assessment.

1a.4 & 1a.5

• One risk should be in place.

• Should not treat patient risk differently from other

organisational risks – all part of one standard.



1.a.3 & 1a.5

• These should be wrapped together.


1a.5 • This statement and wording ‘control options’ could be open to interpretation.

• Overlap with 1a.3.

• Slight repetition with 1a.11.

Actioned – criterion reworded.



1a.6 • Is this necessary? Very basic and would be included in any good risk management system.


1a.6 & 1a.8

• I would wish to see the phrase “and these are reviewed at regular intervals" added at the end of the sentence. I believe this is vitally important and presumably in evidence we would be seeking to view changes which it had been necessary to make as a result of Risk/ Emergency Incidents. Should we not also consider whether or not we require to see any Testing of Emergency Planning Arrangements whether through Live/Table Top Exercises?

Actioned –change made as suggested. Noted – testing of emergency plans included in self-assessment.

1a.7 • This criteria should be redrafted to read: “the effectiveness of the risk management system is

reviewed and modifications made as necessary, in partnership with patient/public fora.”

• Need to define who should review system and how it should

be assessed.



1a.8 • Rather vague – it would be better to state: ‘Emergency Plans developed, implemented and tested to deal with major

Noted – emergency planning criteria

incidents’.

• There needs to be a definition of Emergency Planning (as given for service continuity plans)

• Could be combined with 1a.9.

• Further definition of ‘major adverse events’ is needed.

reworded.

Actioned – definition added Actioned – criterion reworded. Actioned – definition added.

1a.9 • Need to place emergency planning in separate section all together to emphasize its particular importance.

• Service continuity plans needs to be developed for any

significant service failure and not just adverse events. • The measurability of this criterion has been questioned,

particularly the phrase ‘…to promote resilience to significant adverse events.’ It is envisaged that it would be difficult to measure how the service continuity plans promote such resilience. The self-assessment may clarify this.

• The issue of civil contingency planning needs to be added as

part of the continuity planning process. • Need to reword – possibly ‘services continuity plans are in

place to ensure organisations are able to respond to significant adverse events’.

• Need to clarify ‘resilience to significant adverse events’.

• Amend to include ‘Service and business continuity plans…’

Actioned – separate section for emergency/continuity planning.





Actioned – wording revised. Actioned – criterion reworded.

1a8 & 1a.9 • Plans not just ‘in place’ but must be robust, versatile and well tested.

• How will Boards assess and mitigate against ‘vacancy factors’

that pose risks to services let alone during major incidents.

Noted – part of review and self-assessment.


1a.10 • How will this be measured – very open. • Define ‘information’ , ‘intelligence’ or ‘lessons’ would be better

words.

Noted – measured through review and self-assessment. Actioned – definition added.

1a.11 • This duplicates 1a.7 and 1a.5. • The term ‘periodically’ could be interpreted in different ways.

To improve measurability of this criterion, it is suggested that a timescale is specified here.

• I would prefer to see periodically replaced by "reviewed at

regular intervals". • This criteria should be redrafted to read:

“The adequacy of risk assessments, together with existing control measures, is periodically reviewed, in partnership with patient/public fora.”

• Assessment by whom?

Actioned - criterion deleted. Noted – no action taken.




1a.12 • An alternative approach to achieve the objective of the overarching principles would be to add a new criteria along the following lines : “formal and informal methods are used to capture the views, ideas, and experiences of patients, public and staff to inform adequacy of and improvements in risk management practice”.


1b • The criterion encapsulates core, service-wide activity. • Should possibly be a clear complaints process in place with


a system for investigating these complaints. Also a whistle blowing policy encouraging staff to highlight areas of concern.

1b.1 • Does ‘approved’ mean approved by the Board or by a Boards CG sub-committee. Need further clarification.

• The requirement for Board approval would serve to push CG

& RM up the agenda

• Not clear what the reference to ‘approved’ means.

• Define who should approve – could include partners outside

NHS.

• How will prioritisation be achieved?

Noted – no action taken. Noted – Board level review therefore Board approval implicit. Noted – no action taken. Noted – no action taken. Noted – no action taken.

1b.2 • After ‘guidance’, it should say “and best practice statement”.

• Could be strengthened to go beyond requiring systems to ‘prioritise, implement and review national and local standards to guidance’ to a requirement to adopt an evidence based, decision making culture, to include one that prioritises…?

• Suggest add ‘inform’ to prioritise, implement and review.

• Reword ‘A system is in place to review, prioritise and

implement national and local clinical standards and guidance’.

• Possibly too vague.

Noted – no action taken. Noted – no action taken. Noted – no action taken. Noted – no action taken. Noted – no action taken.

1b.3 • The first part is O.K. but how is a board going to measure ongoing improvement in the health of the population. That


can only be measured over a considerable time.

• Decisions on what constitutes ‘evidence’ of improved patient care is another area where the implementation of PFPI is critical. It is recommended that this criteria be redrafted to read: “there is evidence of improved patient care and ongoing improvement in the health of the population, and that this is compiled in partnership with patient/public fora.”

• Reword. • Additional detail required as not clear.

• Suggest adding ‘ongoing’ to improvement in patient care, as

it implies that patient care is not acceptable at present.

• It will take time to demonstrate improved patient care and health. May not be able to meet this on a short term basis.

• Requires a better approach that links local to the Public

Health and Board functions.

• Factors are changing the character of clinical effectiveness away from improving services towards proving that services are popular/necessary. Need to develop assessment questions that tease out this distinction.

Noted – no action taken. Noted – criterion reworded. Noted – detail required included in self-assessment. Actioned - changed as suggested. Noted – no action taken. Noted – no action taken. Noted – no action taken.

1b.4 • Given the reasoning for the proposed new 1a.12 above, it is recommended that this criteria be redrafted to read:

o “formal and informal methods are used to capture the views, ideas, and experiences of patients, public and staff to inform adequacy of and improvements in clinical effectiveness.”

Noted – criterion reworded to reflect comment.

• How does one measure ‘informal’?

• Criterion unclear, possibly reword.



Overall comments on Standard 1

• Standards 1a.4, 1b.2, 1b.3, 1b.4 and 2c. (relating to risk management, clinical effectiveness and communication) would benefit from being linked across to the Staff Governance Standards as they would provide useful information to supplement the evaluation of the impact of workforce development.

• Criteria 1a3.4.5 & 6 seem to overlap and deal with the same

issues. Not clear on the difference between 1a.7 and 1a.11.

• A criterion should be included which specifically reflects the importance of access to the knowledge base as a core part of the infrastructure, which underpins clinical effectiveness activity.

• Should be three sections Risk Management,

Emergency/Continuity planning and Clinical Effectiveness.

• Overall prefer to see some closer linkages made between risk and performance management in the criteria.

• Reference 1 should be listed in the current references.

• Need to ensure contingency plan is there to avoid increasing

risk due to service failures.

• A criterion needs to be defined which reflects the contribution of knowledge services in enabling access to that evidence. Suggest wording as ‘A quality-assured knowledge service is provided by the NHS Board, offering knowledge



Noted – reference to Knowledge Services included in self-assessment. Actioned – changed as suggested.




Noted - reference to Knowledge Services included in self-assessment.

support that reflects the scope of services delivered by the Board, and the Board’s strategic plan’.

• No criteria seemed to require an evidence base to inform

clinical decisions.

• Perhaps need standard around the development of the corporate risk register that has clear links to an operationally based escalation process.

• Suggest a separation between RM and

emergency/continuity planning to replicate how clinical effectiveness is presentationally separated out from these two areas.

Noted – no action taken. Noted - included in Self-assessment


Standard 2

Title/ Standard Statement

• Prefer title ‘Accessible and Responsive care. • Why ‘The health and care experience’? • Remove ‘and the public’.

Noted – no action taken. Noted – no action taken. Noted – no action taken.

Rationale • Reword ‘fair and equal’, and ‘deciding’. • Remove ‘right’ from first sentence.

• Reword ‘As responsible partners in care, people are

expected to be involved in making decisions about their own healthcare’.

• While the need for advocacy services is noted in the

essential criteria there is no comment about Named Persons.

• Requested that ‘carers’ be added.

• Discuss ‘fair and equal’ access – geography being a key

consideration – should be in relation to need.

• Second paragraph – Reword ‘Patients are entitled, and encouraged, to be involved as partners in decisions about the treatment and care and this approach is associated with better outcomes for patients’.

Actioned – rationale reworded.







2a • I believe that we require to be consistent in our wording so that where applicable it relates to Patients, Relatives, Representatives, Carers and the Public e.g. 2a.6 and 2a.7.


2a.1 • There should be a system in place to ensure high quality information is available and in a range of formats.


• OK but the criteria should explain that several methods are used – leaflets/intranet/phone/etc.


2a.2 • National Priorities versus individual needs. • It seems naïve and totally inappropriate to set a criterion that

‘Services should meet the needs of the population’ without any regard for the requirement of Boards to manage within cash limits or the willingness to pay for incremental gains in healthcare benefits. Is it not for the SEHD to decide if a Board is meeting its statutory obligation in providing healthcare and thus a matter for the PAF?

• ‘Population needs’ may be hard to measure.

• Unclear what subject the waiting and response times and

location and availability refer to.

• Perceived to contradict the equality aspect in the standard statement High level – how can this be measured at individual level?

• How is this standard to be met as there is always unmet

need?

• Too broad, perhaps break down into a number of separate criteria.




Actioned – definitions added.

Noted – no action taken. Noted – criterion requires that systems are in place to meet needs – not that needs are met. Noted – no action taken.

2a.3 • Quality of referral is of significant benefit to the patient through improved care e.g. including information about relevant past history, history of allergies, etc. Hence 2a.3 needs to highlight the quality of referral and not just ‘appropriate referral’.

• Unclear how this can be met e.g. great need for referral protocols to tertiary centres but DGHs cannot determine these. Suggest be clear that onus is placed on admitting centre to develop and operate (in consultation with providing



hospitals) robust, transparent, evidence based referral protocols.

• Is this a primary care criteria or secondary care?

• What is meant by regular basis? Is it regularly as each

patient is transferred or is it at regular intervals throughout the patient’s journey of care including long-term care?

• Despite a multidisciplinary meeting to set a package of care,

it has been WICUSN members’ experience that a social worker or even a homecare organizer, a non- professional, can cut this package almost immediately after discharge even when there is no material change in the patient’s condition. – Will this monitoring pick up on these practices and prevent them happening?

• Need to take into account partnership involvement in

developing guidance as part of the assessment achievement.

• Feedback on referral should also be given to clients/carers

to keep them involved in the process.

• It is more ‘systems’ that need ‘audited’ rather than ‘guidelines’ needing ‘monitoring’.

Noted – standards cover all NHS Board services including primary and secondary care.

Noted – review teams will be briefed on what is deemed regularly to ensure consistency. Noted – there will be the opportunity to address such issues during self- assessment and review.

Noted – other agencies noted in criterion refers to partnership involvement.


2a.4 & 2a.6

• These criteria produce challenges to produce clear supporting evidence.

• It will be near impossible to demonstrate 100% compliance,

particularly for Special Health Boards.



2a.4 • Why is a multidisciplinary assessment process needed for Actioned – criterion

diagnosis if one discipline can do it with certainty? Should it not be a ‘robust’ process? Is it referral protocols that are the concern?

• On a general note such meetings are not conducive to

meeting other objectives.

• A robust assessment should be added to stress the assessment required to address patient’s level of need.

• Is ‘considers’ the right word, what about those that are

unable to understand information given to them.

reworded to reflect comment.




2a.5 • Has QIS identified that the Boards have the resources to meet the additional demands placed on them in this criterion? Has the increase in demand be quantified?

• The practice of social work cutting care packages has a

direct impact on carers as they are forced to increase their commitment. Is there any safeguard here or elsewhere to prevent your partners in care from treating carers in this way?

• Need to emphasize carers preferences and views

particularly at discharge.




2a.6 • Do minors have this right or do parents have right to guide information provided?

• Including availability of a second/other opinion.

• Phrase ‘a range of’ not required.

• Should be reference here to information provided by other

agencies and voluntary groups e.g. MS Society, Arthritis Associations.





2a.7 • Does relevant legislation include fiduciary duties? What are Noted – no action taken.

best practice guidelines (e.g. are the SISSG guidelines on MRSA best practice?) Is it ethical to require Boards to follow guidelines that are best clinical practice but unaffordable?

• What about service users lacking capacity to consent?

• Currently incorporates two different elements. These could

be separated i.e. 2a.7 - Patients are enabled… and 2a.8 - Staff are guided by consent policy.

• Reword ‘best’ to ‘good’ which allows commitment to

improvement.




2a.7 & 2a.9

• Incapacity Act?

• These essential criteria should be wrapped together.



2a.8 • Need to balance with need to prevent undue delay in discharge.

• Do these arrangements ensure need is met after discharge

from hospital?

• These criteria need some sort of feedback mechanism built in, as is the case for referral.

• The term ‘aids’ is a little outdated, perhaps read ‘the need

for equipment, adaptations, rehabilitation and support’.

• Suggest 2a.9 goes before 2a.8.

• Other health partners need to be included e.g. hospital staff,

community staff, and health staff in other areas when patients are being transferred back to an area at distance/or another Health Board area.





Noted – criterion 2a9 removed.


2b • It would appear the draft is somewhat disadvantaged by timing, in not having had access to the guidance issued by SEHD recently on impact assessing for equality and diversity (EQIA) and on informing, engaging and consulting the public (IEC). Both sets of guidance will have a profound effect on the practice and culture of governance in Health Boards. It is therefore recommended that the two criteria in this sub-section be redrafted to read :

New 2b.1 – ‘all new and existing activities are developed or redesigned using the impact assessment approach of the EQIA toolkit to ensure that every person has fair and equal access to healthcare and associated services’

New 2b.2 – ‘where activities are delivered in partnership with

other agencies, the impact assessment approach of the EQIA toolkit must be applied across the system partnership’

New 2b.3 – ‘systems are in place to identify, assess and

respond to the needs of groups and individuals within its population who have particular requirements or preferences, and that the principles of IEC are used to frame engagement with those groups and individuals’

Actioned – criteria reworded to reflect comments.


Noted - IEC document added to evidence base.

2b.1 • What can the NHS do to ensure equal access to associated services?

• What systems are referred to?

• Is it fair or equal?



Noted – no action taken. 2b.2 • Would this include the many people in ‘delayed discharge

beds’ who have a requirement for long term care but would choose not to, and have a right not to be forced to spend the last years of their lives in a hospital setting?

• Might be better standing on its own in this section.



• Too broad a statement, needs to be broken down into a number of separate criteria.


2c.1 • I feel that we should add ‘The Strategy should be reviewed at regular intervals to take account of changes which may have occurred’. In evidence it should be possible to see documentation e.g. Comments / Complaints/ Incidents / Changes etc which have affected the Communications Strategy.

• Helpful to expand to include people with sensory impairments and people for whom English is not the first language.

• Could this include issuing carers with general information on

and guidance in general terms on coping with their relative’s condition?

• Perhaps include in the standard the monitoring of developing a strategy for gaining (particularly mental health) patients’ consent to the inclusion of their carer in discussion with themselves and their therapist.

• Given the comments at 2b, it will be self-evident that the IEC

guidance will also have a profound impact in this area. Equally, the very recent issue of new guidance on NHS complaints procedure will require to be reflected in this particular criteria. It is recommended that the criteria be redrafted to read:

“there is a strategy in place which implements the principles and values of the guidance on IEC and on ‘Can I Help You ?’ and which guides, monitors and improves the way that NHS staff communicate with patients, carers and service users.” • Suggest add ‘public’. • What sort of ‘strategy’ is expected and on which issues





Noted – ‘IEC’ and ‘Can I help you?’ included in evidence base.


should it provide guidance. Noted – no action taken. Overall

comments on Standard 2

• The importance of staff communicating with each other is not recognised within this criterion.

• The glossary states that sometimes the phrase ‘service user’

is used instead of ‘patient’ - this sentence uses both. • Importance of ‘single point access’ for communication and

ensuring patients know who to contact and that a responsive service is provided to resolve ‘problems’.

• Critical that staff communicate with each other as well as

patients carers and services users.

• Overall there is no mention of spiritual care; the environment

in which care is provided and if it is fit for propose and appropriate; the role that volunteers play in supporting healthcare services.

• Specific mention of the mechanisms for sharing best

practice across organisation is needed.

• There must be reference to protecting healthcare staff in cases where patients wishes conflict with clinical advice; and cases where inadequacy of resources or design of the model of service delivery affects safe effective service.

• Lacks valuation of public experience.

• The health and care experience has a much more

operational, clinical focus than standards 1 and 3. There may be problems in obtaining meaningful information for this standard if reviewed purely at a NHS Board level and it envisaged that significant input from clinical services across

Actioned - criterion reworded to reflect comment. Actioned – criterion reworded.



Noted – spiritual care policy requested in core evidence.





the NHS Board would be required to ensure relevant, useful information is collected.

• We hope the development of multi-agency working involves

all relevant agencies so are agreed and owned by respective agencies and staff. Recommend standard including information sharing in integrated health and social care organisation.


Standard 3

Standard Statement/ Rationale

• Concern about the use of the word ‘confident’ – media influence.

• Use ‘assured’ or ‘reassured’.

• States what public is aiming for rather than Board.

• Reword ‘NHS Scotland provides assurance to the public

about safety and quality of NHS care’.

• The detailed criterion of 3a seems a mixture of health service planning and quality assurance issues. For clarity rename 3a ‘Organisational System – Quality Assurance’ and then 3d to ‘Organisational System – Performance Management’ to end confusion.

• Rationale – use ‘people working together’ rather than

‘collaborative working’.

• Needs to be more specific to better link the points made to the essential criteria.

• Reword ‘‘Public confidence and trust in the NHS is

enhanced through involving patients, carers and the public in the development and redesign of services’.

Noted – standard statement reworded. Noted – standard statement reworded.

Noted – standard statement reworded.

Noted – standard statement reworded.





3a.1 • Should read ‘statutory and mandatory’.

Noted - mandatory removed.

3a.2 • With what has already been observed in relation to the issue of guidance on IEC, it is recommended that this be redrafted to read:

“patients, carers and the public are consulted, within the principles, practice and values in the guidance of IEC, when an NHS Board is planning, monitoring and redesigning

Noted – IEC document included in evidence base.

services”. • Should this criterion be about the development of services

rather than planning, monitoring and improving services?

• Reword along the following lines: "Patients, their Relatives/ Representatives, Carers and the Public are informed, engaged, and consulted when the NHS Board is Planning, Changing, Monitoring and Improving Services. This process should always be initiated at the inception of the proposed action so that there is Patient Focus and Public Involvement ". Unfortunately this does not always seem to happen hence the reason for public discontent and in some cases anger.

• There is a greater focus on monitoring and managing of

staff and little consideration of their contribution and value to the service. Stronger reference to their contribution may lead to improved levels of staff buy-in to the standards.

• Suggest changing ‘engaged’ to ‘involved’ and add in ‘given

feedback’.

• Whilst it is essential to inform, engage and consult there is no indication here that assess the extent to which opinions and preferences are included.

• Could include ‘Improving the delivery of service’.

Noted – planning covers development.

Actioned – criterion reworded to reflect comments.


Actioned – reference to staff included in criterion.

Actioned – changed as suggested. Noted – no action taken.

Noted – no action taken. 3a.3 • The responsibility of individuals as well as teams such as

practice teams, to deliver the clinical governance agenda of NHSScotland, needs to be highlighted. This is in addition to the issues of Staff Governance and refers to the individuals’ clinical responsibility. My comments are made in view of the recent Inquiries such as Shipman, Ayling,


Neale and others.

• Remove ‘individual’.

• Requirement for evidence of action could be added to essential criterion.

• CHP not detailed in glossary.

• Need comma after individual, and need to be consistent in

terminology i.e. CHPs Divisions.

• Should be expectation that reporting is published internally and externally to organisations/divisions; and clients or carers should be involved here.


Noted – evidence requirements included in self-assessment.


Actioned – changed as suggested. Noted – no action taken.

3a.4 • Is it systems on quality standards? • Will your standard ensure meaningful quality training and

appropriate professional line management for untrained people employed by other agencies to deliver hands on care to frail and disabled people?

• What do ‘other agencies’ refer to? Need to further clarify.

• Priority should be given to systems of clinical quality

assurance, but concerned about the patchy implementation due to resource limitations and the slow progress of IT developments.

• Regional planning and joint futures should specifically be

mentioned in this essential criterion.

• Refers to services provided jointly with other agencies but there is no mention of links with equivalent quality assurance processes within partner agencies such as



Actioned - see glossary




Local Authority Social Work Departments. 3a.5 • Wrap into 3a.2.

• Redraft to read : ‘systems are in place to seek feedback on services and that this, within the principles, practice and values in the guidance of IEC, is used to inform the planning, monitoring and redesign of services’. • Helpful to specify the sources and types of evidence

required.

• Very broad.


Noted – IEC document included in evidence base.

Noted – evidence requirement included in self-assessment. Noted – no action taken.

3a.6 • Agree that research should be subject to ethical review, however ethical guidance can sometimes prevent/restrict research activity rather than support it.


3b.1 • The wording employment checks could be replaced with pre-employment checks as these should be carried out prior to appointment-especially in light of Children’s Act and Disclosure requirements.

• The system in place to record registration details of

professionals requiring registration to practice should also be capable of flagging up, in advance dates that registration is due for renewal.

• How can full clearance be given with different employment

statuses of many NHS staff?

• Add a standard to require Health Boards to establish systems to monitor the on-going competence of their professionally qualified staff through work place assessment, CPD support, appraisal and revalidation. Such a standard will emphasize the link between clinical competence, risk management and quality improvement.





• Would be strengthened by the insertion of pre-employment

checks. The core evidence required would benefit from the inclusion of:

- Disclosure Scotland Checks - Character/employment references - Any legislation (some yet to be defined) relating to

the protection of Vulnerable Adults and Protection of Children

- Registration checks for healthcare professionals, and other checks for those, who in future, may be listed on an ‘occupational’ register.

• There are no essential criteria identified for continuing

(professional) development other than clinical supervision. • These checks should be a regular intervals.

• Referring to professionally qualified staff – should also

reference other staff.

• How will it be ensured that those with responsibility have competency and training in their areas?





Noted - included in staff governance standard.

3b.2 • The criterion needs to more clearly link staff governance to clinical governance.

• Should use a different word to ‘managed’ – deemed

inappropriate.

• Reword.

• Could be clearer regarding what is expected of the links to ‘Staff Governance’ arrangements.





3b.3

• Add ‘where appropriate’ after ‘managed’. • The term ‘clinical supervision’ needs to be explained e.g.


Actioned - see glossary.

the intention and processes are different when applied to Trainees such as GP Trainees as compared to Psychotherapists.

• Could this be extended to ensure appropriate professional

line management for untrained people being asked to perform some clinical procedures?

• ‘Clinical supervision’ means different things to different

professional groups and it may be worth using the term ‘facilitating reflective practice’.

• Plus a staff development programme.

• We suggest that the criteria include a reference to

implementation.

• There is no definition of ‘clinical supervision’ in glossary.


Noted – definition of clinical supervision included in glossary.




3c.1 • It is suggested this criteria be redrafted to read : “there is an external communications strategy in place which is impact assessed using EQIA, has been subject of consultation using IEC, and which is systematically monitored and reviewed in partnership with patient/public fora”. • I believe that this requires expanding and clarifying as to

whom/what is actually covered by this. The wording is very vague.

• Why just external and not internal?

• Statement needs to be more explicit – is it about

communicating assurance to the public? Internal communication just as important so should be included.

Noted – EQIA and IEC included in evidence base.


Noted – internal communication covered in standard 2.

Noted – internal communication covered in standard 2.

• ‘External Communications Strategy’ needs simplified i.e.

plain words such as ’media’.


3d • How are these criteria operationalised?

• Need to more clearly explain the link between performance management and clinical governance. Currently too implicit.

• Why is this criteria needed?

• ‘Service Management’ has not been sufficiently defined

here.





3d.2 • Remove ‘ensuring prioritisation of decision making’ as this is confusing unless it is to do with PAF.

• Intent should be clarified and language simplified.


Noted – no action taken. 3d.3 • Focuses on information held pertaining to patients and

there is nothing about info held on staff and their rights to access to this.

• This would read better if stated as ‘Improvement is

achieved ….’.

Noted -criterion removed.

Noted – criterion removed.

3e • Is this both patient and staff information? This should be made clearer.

• The issue of staff confidentiality, particularly with in the context of Freedom of Information legislation, needs to be considered.

• Possible changes to staff confidentiality arrangement s

may serve to put off many staff from reporting incidents where this is voluntary.



3e.1 • Reword ‘A governance framework is in place which ensures the ethical…’


3e.2 • Does this go beyond requiring Boards to comply with Noted – no action taken.

legislation? Perhaps compliance with legislation is not a matter for QIS.

3e.3 • Can be written better. Noted – criterion reworded. 3e.5 • Define ‘Information’.


Overall comments on Standard 3

• In 3e it would be helpful to include more explicit reference to regulating information sharing in integrated health and social care organisations.

• Need to focus on workforce planning as workload is a

major issue in the application of quality standards and the provision of quality service.

• 3a, b and d – very over-simplified. There is no mention of

staff concerns, duty of care, training and development, competencies, fitness for work, recruitment and retention or staff morale which are all important!

• What does ‘collaboration’ mean? Is it an internal or

external concept or both? • The communication of public assurance is absent. There

should be something included specifying how Boards seek to assure the public.

• Add a reference to qualitative issues on relation to Staff

Governance.







standards for clinical governance & risk management

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