National Health Service (Independent Review Body)(Amendment) Regulatio

Summary

A request was made for consultation responses and documentation regarding the 2021 amendments to NHS Independent Review Body regulations, specifically questioning the exclusion of public consultation and the handling of 2006 recommendations. The authority provided a partial response containing a letter from the NHS IRB dated November 2020, which raised concerns about the consultation process and the complexity of the proposed complaint layers, while other requested documents were withheld.

Key Facts

• The request targeted the Cabinet Office regarding the National Health Service (Independent Review Body)(Amendment) Regulations 2021.
• The outcome was classified as 'Some information sent but part exempt'.
• A letter from the NHS Independent Review Body dated 10 November 2020 was disclosed as part of the response.
• The NHS IRB noted that the Social Services IRB was not included in the consultation process.
• The NHS IRB identified five potential layers for complaint resolution: Commissioned Service Provider, Manx Care, DHSC, IRB, and Tynwald Commissioner.

Data Disclosed

• 10 November 2020
• 2021
• 2004
• 2006
• 33/2006
• 2019
• 15 years
• five possible layers
• 3.1.1.8
• 3.1.1.14
• 4.1.1.7

Original Request

National Health Service (Independent Review Body)(Amendment) Regulations 2021, National Health Service (Complaints) (Amendments) Regulations 2021, Social Services Independent Review Body (Amendment) Regulations 2021 1. Please provide a copy of the consultation responses provided by the following on the above proposed Independent Review Body healthcare complaint regulations: Health IRB, the Health Services Consultative Committee, Isle of Man Medical Society, Isle of Man Dental Association, Isle of Man Pharmacy Contractors Association, Isle of Man Association of Optometrists and Registered Opticians, Chief Social Worker, DHSC. 2. Please provide a copy of the documentation / minutes/ telephone calls/ reports etc which relate to the approach agreed by both the Department of Health and Social Care and the Health and Care Transformation Board (Cabinet Office) not to follow the recommendations to update the National Health Service (Independent Review Body) Regulations 2004 and National Health Service (Complaints) Regulations 2004 as voted for by Tynwald in 2006 (reference 33/2006), some 15 years ago. 3. Please confirm if any of the IRB recommendations designed to improve healthcare complaints procedure and protect patients in 33/2006 will be included in the 2021 regulations. Please provide a list of 2006 recommendations to be included and those not to be included. 4. Please advise on what date DHSC and the Cabinet Office resolved not to include the recommendations to update the IRB as outlined in 33/2006. 5. Please advise why a decision was made by DHSC and the Cabinet Office not to consult the public or patient representative body in relation to the proposed healthcare complaint regulations, particularly when it was established in 2019 by the Sir Jonathan Michael report that the healthcare complaint regulations would need to be amended in 2021. 6. It appears that proposed healthcare complaint regulations which directly affect patients and the public will not be made available to the public prior to being laid before Tynwald. Please clarify and provide a copy of the correspondence relating to this decision. 7. Following consultation, please advise if the amended Duty of Candour Regulations will be made available to the public prior to being laid before Tynwald. 8. Commonly a full consultation report is issued after public consultation. This does not appear to have happened in relation to the Duty of Candour, only a summary has been produced. Please can advise why in relation to Duty of Candour a full report has not been issued for the public.

Data Tables (1)

Full Response Text

INDEPENDENT REVIEW BODY (Investigating Complaints of NHS Treatment) (Bing Aavriwnyssyn Neuchroghagh) P.O. Box 281 DOUGLAS Isle of Man, IM99 2SH nhsirb@manx.net

10 November 2020

Health and Care Transformation Programme Management Office 2nd Floor Heywood House Ridgeway Street DOUGLAS IM1 EW1

Dear

Consultation on Complaints Regulations

Thank you for forwarding the consultation documents for consideration by the NHS Independent Review Body (IRB).

It could be argued that the consultation process is to some extent flawed in as much as there has not been the opportunity for the NHS IRB, as a key interested party, to meet with the Manx Care Transformation personnel to discuss in depth the processes, review how e within the new arrangement. It is also noted that it has not been possible for one of the key stake holders, i.e. the Social Services IRB, to be included in the consultation and therefore comments on its behalf are being sought via the Department of Health & Social Care (DHSC).

The IRB has had to rely on the paperwork to assess the nature and impact of the draft plans in order to provide responses. In thus considering, it is apparent that the Regulations have been based on existing legislation, and e resultant strategy is understood to operate whilst the DHSC is drafting an overarching policy to deal with all manner of complaints. However this will not affect the fact that, as it appears, there are five possible layers which could be encountered by a Complainant in attempting to resolve issues of concern. Referral to the Commissioned Service Provider > Manx Care > DHSC > IRB > Tynwald Commissioner. The IRB would query the place of the Tynwald Commissioner for Administration as the last tier, having been advised previously by the DHSC that the IRB is exempt from the requirements of the relevant legislation.

Explanations would be helpful as to: -

How a complaint that is not consid administered by Manx Care, reference the Chart and 3.1.1.8?

 INDEPENDENT REVIEW BODY 
  (Investigating Complaints of NHS Treatment)

What mechanism would be used to resolve complaints other than the IRBs, reference 3.1.1.14 and 4.1.1.7?

In investigating a complaint where the IRB concludes that further local resolution should take place, would this involve action by the DHSC, by Manx Care and then to the Service Provider?

Notwithstanding, whilst it is appreciated the documents have had to be prepared within a limited timeframe to meet Manx Care deadlines, the IRB does have reservations and concerns regarding the proposals contained therein. Both the consultation file and in - (albeit the latter is in the very early stages) does not deliver a succinct overview of how it is envisaged the procedures will operate. As it stands, this is a somewhat unwieldy arrangement which the Service User, being central to the delivery of services as emphasized in the Manx Care Bill, could well find a formidable process when making a complaint and would require detailed direction.
Similarly, all involved in whatever capacity in the provision of healthcare would need a comprehensive guide. Another factor is the length of time a complaint might take to be completed from start to finish.

One final comment with regard to the earlier mention of the Social Services IRB: as noted the strategy for the handling of complaints is under review by the DHSC, with the possibility of an integrated review body being established to cover the two IRBs and the MHC.

and

had talks with Ms Magson when it was mooted that for an interim period the NHS IRB would be requested to undertake the Social Services IRB complaints. This is subject to discussion as to whether members would be prepared to accept the additional workload and whether they have the required background to do so. The membership of the Social Services IRB includes professional Members whereas the constitution for the NHS IRB consists of lay members. However, should it be possible to reach some agreement, would not the revision of the Social Care IRB regulations be inconsequential?

Yours sincerely

Government Office Douglas Isle of Man IM1 3PN Telephone: (+44) 01624 686244 Website: www.gov.im/co

Our ref: 1692477 1 April 2021

Dear ###,

We write further to your request which was received on 4 March 2021 and which states:

"National Health Service (Independent Review Body)(Amendment) Regulations 2021, National Health Service (Complaints) (Amendments) Regulations 2021, Social Services Independent Review Body (Amendment) Regulations 2021 1. Please provide a copy of the consultation responses provided by the following on the above proposed Independent Review Body healthcare complaint regulations: Health IRB, the Health Services Consultative Committee, Isle of Man Medical Society, Isle of Man Dental Association, Isle of Man Pharmacy Contractors Association, Isle of Man Association of Optometrists and Registered Opticians, Chief Social Worker, DHSC. 2. Please provide a copy of the documentation / minutes/ telephone calls/ reports etc which relate to the approach agreed by both the Department of Health and Social Care and the Health and Care Transformation Board (Cabinet Office) not to follow the recommendations to update the National Health Service (Independent Review Body) Regulations 2004 and National Health Service (Complaints) Regulations 2004 as voted for by Tynwald in 2006 (reference 33/2006), some 15 years ago. 3. Please confirm if any of the IRB recommendations designed to improve healthcare complaints procedure and protect patients in 33/2006 will be included in the 2021 regulations. Please provide a list of 2006 recommendations to be included and those not to be included. 4. Please advise on what date DHSC and the Cabinet Office resolved not to include the recommendations to update the IRB as outlined in 33/2006. 5. Please advise why a decision was made by DHSC and the Cabinet Office not to consult the public or patient representative body in relation to the proposed healthcare complaint regulations, particularly when it was established in 2019 by the Sir Jonathan Michael report that the healthcare complaint regulations would need to be amended in 2021. 6. It appears that proposed healthcare complaint regulations which directly affect patients and the public will not be made available to the public prior to being laid before Tynwald. Please clarify and provide a copy of the correspondence relating to

this decision. 7. Following consultation, please advise if the amended Duty of Candour Regulations will be made available to the public prior to being laid before Tynwald. 8. Commonly a full consultation report is issued after public consultation. This does not appear to have happened in relation to the Duty of Candour, only a summary has been produced. Please can advise why in relation to Duty of Candour a full report has not been issued for the public."

Our response to your request is as follows: I have detailed below the information.

s25(b)(i)&(ii) While our aim is to provide information whenever possible, in this instance we are unable to provide some of the information you have requested because it is absolutely exempt under section 25 of the Act (absolutely exempt personal information). The reasons why that exemption applies are that: • The Cabinet Office is satisfied that the information amounts to personal data of which you are not the data subject; and • The Cabinet Office is satisfied that disclosure of the information would contravene one of the data protection principles as set out at Article 5 of the General Data Protection Regulation as it applies in the Isle of Man pursuant to the Data Protection (Application of GDPR) Order 2018, namely that the Cabinet Office can only disclose the information where it would be fair, lawful and meet one of the conditions for lawful processing in Article 6 and in this case, none of those conditions have been met.

1. Please provide a copy of the consultation responses provided by the following on the above proposed Independent Review Body healthcare complaint regulations: Health IRB, the Health Services Consultative Committee, Isle of Man Medical Society, Isle of Man Dental Association, Isle of Man Pharmacy Contractors Association, Isle of Man Association of Optometrists and Registered Opticians, Chief Social Worker, DHSC. The Health and Care Transformation Programme in the Cabinet Office confirms that it carried out a key stakeholder consultation on the proposed changes to the above named Regulations. The consultation was carried out in conjunction with the Department of Health and Social Care. The key stakeholders consulted were those listed above by the requestor. Of those consulted, the Health IRB, the Health Services Consultative Committee and the Isle of Man Dental Association provided responses and copies of these responses are enclosed with this freedom of information response.
2. Please provide a copy of the documentation / minutes/ telephone calls/ reports etc which relate to the approach agreed by both the Department of Health and Social Care and the Health and Care Transformation Board (Cabinet Office) not to follow the recommendations to update the National Health Service (Independent Review Body) Regulations 2004 and National Health Service (Complaints) Regulations 2004 as voted for by Tynwald in 2006 (reference 33/2006), some 15 years ago.

There has not been a decision made by the Health and Care Transformation Programme to not follow the recommendations contained in item 33/2006 referenced above. The current changes to the Regulations being brought to Tynwald are administrative in nature and their purpose is to allow the newly established Manx Care to have a statutory footing on which to handle complaints when it goes live on 1st April 2021. More substantive changes to the legislation relating to complaints are planned to be made as part of the National Health and Social Care Services Bill. Policy work for this Bill has started and will include a comprehensive review of complaints processes. The public will have an opportunity to contribute as part of the consultation on that Bill. 3. Please confirm if any of the IRB recommendations designed to improve healthcare complaints procedure and protect patients in 33/2006 will be included in the 2021 regulations. Please provide a list of 2006 recommendations to be included and those not to be included. No changes from 33/2006 are being included in the Regulations at this stage. The changes included in the 2021 Regulations are only administrative to allow Manx Care to handle complaints when it is established under the Manx Care Act 2021. 4. Please advise on what date DHSC and the Cabinet Office resolved not to include the recommendations to update the IRB as outlined in 33/2006. No decision has been made to exclude the recommendations outlined in 33/2006. The changes being made as part of the 2021 Regulations are as a result of the establishment of Manx Care; however, the legislation relating to complaints will be subject to a further substantive review later this year as part of the National Health and Social Care Services Bill. 5. Please advise why a decision was made by DHSC and the Cabinet Office not to consult the public or patient representative body in relation to the proposed healthcare complaint regulations, particularly when it was established in 2019 by the Sir Jonathan Michael report that the healthcare complaint regulations would need to be amended in 2021. It is worth noting that, whilst the updates to the Regulations have come about due to the establishment of Manx Care, it was not established as part of Sir Jonathan Michael’s report that the health or social care complaints regulations would need to be amended. This became apparent as part of drafting the Manx Care Bill 2020. There is no requirement for the Department of Health and Social Care to consult the public in relation to the proposed amendments. However, the Transformation Programme has adopted the principle that patients and service users are fully engaged in, and at the centre of, all aspects of planning and delivery of health and social care as recommended by Sir Jonathan Michael in his final report. The Department of Health and Social Care is being supported by the Health and Care Transformation Programme to implement this principle more fully going forward. However, the Transformation Programme did make a

decision to only consult as required (with key stakeholders) in this instance to ensure that the changes were made in time for Manx Care going live on 1st April 2021. Another consideration in the decision making was that these changes are administrative in nature and only allow for Manx Care to be able to fit within the existing complaints processes. The general intention for the amendments being made to the Regulations at this stage is to allow complaints about services to be dealt with by Manx Care in the same way that they are currently dealt with by the DHSC and to allow them to continue to be referred to the relevant IRB. They do not change any pre- existing complaints process in any significant manner. More substantive changes to the legislation relating to complaints are planned to be made as part of the National Health and Social Care Services Bill. Policy work for this Bill has started and will include a comprehensive review of complaints processes. The public will have an opportunity to contribute as part of the consultation on that Bill. As part of the key stakeholder consultation, the Health Services Consultative Committee were consulted about these changes. Their role is to provide independent scrutiny and advice on the performance, effectiveness and operation of the Island’s health services. Their response is included in answer to the first question asked in this Freedom of Information request. 6. It appears that proposed healthcare complaint regulations which directly affect patients and the public will not be made available to the public prior to being laid before Tynwald. Please clarify and provide a copy of the correspondence relating to this decision. The complaints regulations are secondary legislation which could not be formally made until the Manx Care Bill 2020 received Royal Assent. As such, they could not be made available on the Tynwald Order paper ahead of the Tynwald sitting in the usual way. However, the National Health Service (Independent Review Body)(Amendment) Regulations 2021, National Health Service (Complaints) (Amendments) Regulations 2021 and Social Services Independent Review Body (Amendment) Regulations 2021 can now be viewed on the Supplementary Order Paper for the

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