Challenging the Regulators - Nant Ltd

Challenging the Regulators During the NASHiCS Learning and Development Forum 2015, a masterclass was delivered on how to prepare and challenge a CQC inspection within a care home. The session walked through a number of key areas that the CQC judge and inspect, the relevant regulations and most importantly – how to prepare for the inspection and how to challenge the outcome. The session was delivered by Sue Sheath, Director of Regulation at Barchester Healthcare and Andrew Peel, Partner at Browne Jacobson LLP. The Scenario A scenario was given in which a nursing home had experienced reasonable success and smooth sailing for its first 4 years of operation, but following the departure of the original manager, had taken a turn for the worst and received a lower grade following a CQC inspection, leading to the local authority placing an embargo until sufficient improvements had been made. The home suffered damages to its reputation and private residents sought care elsewhere. Additionally, ten statutory notifications were made to the CQC, staff morale is low, a string of complaints were made by relatives and both the manager and 6 members of staff left the home, but the previous manager has agreed to assist in an unofficial capacity until a new manager is found. As things appear to go from bad to worse, the company is able to recruit some staff to cover those that left, including a friend of one of the current nurses, 2 agency nurses and a work experience care assistant. Unknown to the company, the new work experience staff is a relative of one of the residents who felt their complaints weren’t handled properly and is keeping a diary of activity within the home to help build evidence for solicitors. During a visit to a resident, the family member found them in a worrying state and requested to see the records and check that the home was aware of the cause of this predicament and suitable changes had been made. After 3 weeks of work experience the care assistant left and handed the diary to the solicitors, who have written to the home detailing the relatives’ concerns and advising that the matters will be disclosed to the CQC. The diary covered incidents including nursing staff mistreating residents in order to save time or reduce workload, several residents being involved in falls and accidents because they weren’t getting the assistance they needed, instances of serious injury without proper handling and it was discovered that one of the nurses at the home hasn’t been registered in years. The company thinks the complaint is unfair and is terrified of receiving a visit from the CQC.

Key regulatory framework •

Care Quality Commission (Registration) Regulations 2009

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Health and Social Care Act 2008

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The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (especially the fundamental standards)

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The Health and Social Care Act 2008 (Regulated Activities) Regulations (Amendment) Regulations 2015

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Guidance for providers on meeting the regulations: Health and Social Care Act 2008 (Regulated Activities) Regulations 2015 (Part 3, as amended) and Care Quality Commission (Registration) Regulations 2009 (Part 4, as amended) published by CQC, March 2015

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How the CQC regulates community adult and social services care (CQC provider handbook, March 2015)

Other regulatory provisions •

Data Protection Act 1998 (living) / Access to Health Records 1990 (deceased)

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The Health and Safety at Work etc Act 1974

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Management of Health and Safety at Work Regulations 1999

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Reporting of Injuries, Diseases and Dangerous Occurrences Regulations (RIDDOR) 2013

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Safeguarding Vulnerable Groups Act 2006

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Corporate Manslaughter and Corporate Homicide Act 2007

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Coroners and Justice Act 2009

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Coroners (Investigation) Rules 2013 & Coroners (Inquest) Rules 2013

CQC’s five key domains •

Safe? –

Are people protected from abuse, ill treatment and avoidable harm? 

Includes emotional, physical, psychological and emotional harm, abuse, discrimination and neglect

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Effective? –

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Caring? –

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Do staff involve and treat residents with compassion, kindness, dignity and respect?

Responsive to people’s needs? –

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Does the care, treatment and support provided achieve good outcomes, promote a good quality of life and is based on best available evidence?

Do residents get the care they need, are listened to and have their rights and diverse circumstances respected?

Well led? –

How do leadership, management and governance assure the delivery of highquality, person centred care, delivered in an open, fair, transparent, supportive and challenging culture?

IS IT SAFE? Safety: regulatory framework Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 •

Regulation 12 – safe care and treatment –

Care and treatment must be provided in safe way

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Assess H&S and welfare risks and mitigate so far as is reasonably practicable 

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Do not provide care at a risk of harm that could be avoided

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Suitably qualified / competent staff

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Premises and equipment are safe and used in intended way

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Proper and safe management of medicines

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Infection – risk assessment, prevention, detection, controlling spread

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Timely care planning and appropriate sharing of information

Regulation 13 – safeguarding users from abuse and improper treatment –

Systems and processes established to prevent and immediately investigate and take action against actual or suspected abuse (this includes neglect and degrading treatment)

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Care or treatment must not be degrading or significantly disregards needs of the service user

Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 •

Regulation 15 – premises and equipment –

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Clean, secure, suitable, properly used and maintained and appropriately located 

NB 1: layout of premises must be suitable for its purposes

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NB 2: any alterations to premises and equipment used to delivery care must be in line with current legislation and guidance

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NB 3: Any changes to premises must be informed by risk assessment, with appropriate contingency plans in place where this is not possible

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NB 4: Regular health and safety risk assessments of premises, including equipment – findings must be acted upon

Maintain standards of hygiene appropriate for purposes of premises


Regulation 18 – staffing –

Sufficient numbers of suitably qualified, competent, skilled and experienced persons

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Appropriate training and support, professional development, supervision and appraisal as necessary to carry out duties. This includes statutory and mandatory training as well as other training identified as necessary to carry out role.

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Obtain further qualifications appropriate to role

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Evidence of continuing training, development and take appropriate action where requirements are not being met


Regulation 19 – fit and proper persons employed –

Requirements of employees 

Good character

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Relevant and requisite qualifications, skills, experience and competence necessary for role

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Healthy (after reasonable adjustments) to perform role

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NB 1: if the provider considers the candidate is suitable, despite not meeting certain characteristics, reasons must be recorded

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NB 3: systems must be in place to assess competence before working unsupervised in role

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NB 3: person can undergo training whilst in the role is suitable qualifications, skills and experience

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NB 4: Selection and interview processes must be designed to check the accuracy of applications

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Recruitment procedures to ensure fit and proper persons are employed

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Registration with relevant professional body

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Where person does not meet requirements – take necessary and proportionate action to ensure compliance, and inform the regulator 

NB 1: Provider must respond immediately concerns about a person’s fitness or ability to carry out duties, including responding immediately if there is an imminent risk to others. This response must be fair to the person and follow the correct procedures

CQC (Registration) Regulations 2009: Regulation 18: Notification of other incidents •

Immediate notification of certain events if they occur during carrying on of regulated activity or as a consequence of the regulated activity, including… –

s2(a) Injury to service user which, in reasonable opinion of health care professional, resulted in impairment of sensory, motor or intellectual functions of service user that are unlikely to be temporary; changes to structure of body of service user; service user experiences prolonged psychological harm or prolonged pain; shortening of life expectancy of service user.

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s2(b) injury to service user, which in reasonably opinion of health care professional, requires treatment in order to prevent death of service user; injury that – if left untreated – would lead to outcomes in ss2(a)

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s2(e) any abuse or allegation of abuse in relation to service user (where abuse includes neglect and physical ill treatment)

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s2(f) any incident reported to, or investigated by, the police

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s2(g) any event which prevents/ threatens provider’s ability to continue regulated activity safely as per registration requirements, including 

Insufficient no. of suitability qualified, skilled, experienced and competent staff

Family and residents – is it safe? •

Residents left in soiled bedding – this creates a risk of infection

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Numerous unwitnessed falls

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Pressure ulcer does not appear to have been treated

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Inadequate staffing

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Do residents receive the appropriate care from external healthcare agencies e.g. tissue viability nurse, being taken to hospital?

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Ill treatment of residents – handled roughly and seem to be neglected

The residential home management: immediate issues to address – safe? •

How are residents kept safe? –

Check whether the falls / lifting training delivered to staff is up to date 

Identify evidence of training

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Identify non-compliance with training (refresher courses; supervision until competent)

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Check the hoist equipment and replace as required

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Confirm suitability of arrangements for purchase, service, maintenance and renewal and replacement of equipment (and premises)

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Confirm there is sufficient / suitable equipment and support facilities (e.g. bathrooms) to provide services

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Ensure staff are using equipment as intended – if not, why not?

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Ensure premises are easy for residents to navigate, access and egress

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Safeguarding residents from improper treatment

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Identify staff – disciplinary action - notify police and professional organisations

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Take steps to redress abuse and minimise risk of this happening again

Have the correct notifications been made? 

Statutory notifications to the CQC – death of resident / falls

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RIDDOR – scalding / falls

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Risk management –

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Have we reviewed the untoward events and shared this information / acted upon it?

Staffing (departures and competence) –

Recruitment to minimise impact of staff departures on service being provided

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Undertake remedial steps in relation to Nurse Grubb’s employment at the home (dismissal), including compliance with obligation to report to CQC

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Concerns regarding fitness to practise - consider whether to refer any other staff to professional organisations

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Ensure those responsible for recruitment understand and follow recruitment policy

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Review procedures for recruitment of suitably qualified staff and skills mix required

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Ensure awareness that all checks are to be undertaken in advance of employment

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Check qualifications and registration of all recently recruited staff

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Remind of need to ensure new staff undergo induction programme

Protection from infection and medicines management –

Initiate review to ensure residents are medically reviewed when required and receiving prescribed medication as required

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Confirm staff are aware of their responsibilities and they follow the home’s policies

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Are the premises clean and free from odours? Check cleaning schedule is appropriate and ensure its implementation

CQC inspection: is it safe? •

How are the residents kept safe - general? •

Is there an appropriate level of scrutiny and oversight (overall responsibility at board level)?

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Does the home consult and adhere to the regulations and national guidelines in delivering care ?

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Are the premises fit for purpose in accordance with legislation and national best practice?

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Is there a culture of vigilance and reporting / raising concerns by staff and residents (supported by appropriate processes)?

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•

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Does the home deliver care based on individual risk assessments / plans and make reasonable adjustments when required?

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Can the home demonstrate it has done everything reasonably practicable to provide safe care and treatment?

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Is there clear documentary evidence of reporting incidents internally and relevant external organisations?

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How does the home monitor the implementation of improvements?

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Are there procedures in place to deal with emergencies?

How are the residents kept safe - safeguarding? •

Does the home review incidents and complaints to identify potential abuse and take preventative action, including escalation where appropriate?

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Can staff demonstrate knowledge of local safeguarding policies and procedures?

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Have the relevant safeguarding referrals been made to and has CQC been notified?

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Is safeguarding training provided to all staff, including on induction?

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Are staff aware of their individual responsibilities in relation to safeguarding?

How are residents kept safe – premises? •

Is all equipment stored, maintained, and used in line with the manufacturer’s instructions?

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Is the equipment accessible at all times to meet needs of persons using the service or obtained in reasonable period of time (including moving and handling equipment)?

How are residents kept safe – financial considerations? •

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Are there in place operational policies and maintenance budgets to ensure equipment, building, electrical systems etc are operationally sound and safe

Risk management •

Sharing information regarding risks

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Assessment of risks to residents and staff

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Responding to untoward events and review of safeguarding and accidents

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Staffing •

Safe recruitment – steps taken to ensure ‘Nurse Grubb’ situation does not occur again?

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What processes are in place to ensure ‘fit and proper persons are employed’, in particular registration and whether they are of ‘good character’?

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Is there a systematic approach to determining the appropriate number of staff and skills mix required – how does this system permit the timely adaptation to residents’ needs?

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What provisions are in place to ensure sufficient and suitable persons are deployed to cover emergency and routine work?

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Does the recruitment and the staff deployment processes comply with current legislation and guidance – are they suitable and effective?

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Is recruitment supported by an induction and training programme (including regular and documented audits and refresher training for persons identified as requiring it; the supervision of persons not meeting the standard)?

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Are processes in place to ensure new staff are supervised until they can demonstrate acceptable level of competence allowing them to work unsupervised?

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Are there adequate disciplinary and staff accountability procedures in place?

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Are there robust systems in place to respond to concerns to staff member’s fitness once appointed to role

Protection from infection and medicines management •

Do the home’s policies follow relevant up to date guidance?

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Are these policies available to staff?

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How does the home monitor adherence to these policies?

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Are the staff applying the policies in practise

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Are the premises and equipment cleaned and decontaminated in line with current legislation and guidance – does the home have policies to support this requirement?

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Is the home disposing of domestic and clinical waste as per legislation and guidance – what provisions are in place?

IS IT EFFECTIVE? Effective: regulatory framework Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 •

Regulation 14 – meeting nutritional and hydration needs

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Provision of nutrition and hydration that will sustain life and good health

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Supporting user to eat / drink –

NB 1: Ensure appropriate assessments are undertaken by suitably qualified staff and these are reviewed / updated on regular basis

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NB 2: Assessments must follow nationally recognized guidance

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NB 3: Regular review and changes responded to in good time

CQC (Registration) Regulations 2009 •

Regulation 13 – financial position

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Service provider must take all reasonable steps to carry on regulated activity in manner to ensure financial viability to achieve aims / objectives set out in ‘statement of purpose’ (aims, objectives and services provided for purposes of carrying on regulated activity)

Family and residents – is it effective? •

Residents are not supported in drinking

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Residents do not appear to be receiving the appropriate care •

The standard of care is unacceptable

The residential home management: immediate issues to address – effective? •

Effective care provided by staff qualified to deliver it to residents? –

Check - are the right staff appropriately assessing residents’ needs?

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Is staff training – especially mandatory training - up to date (including volunteer staff)?

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Meeting eating and drinking needs? Review and issues reminders that staff must ensure:

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Water is be available and accessible to people at all times (other drinks should be available periodically during the day and night)

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People are encouraged and supported to drink

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Food and drink is placed within easy reach

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Persons requiring support are given enough time to take on adequate nutrition and hydration

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They meet these needs and encourage independence in residents

Access to healthcare –

Have the correct referrals to hospital and tissue viability nurses been made?

CQC inspection: is it effective? •

Effective care provided to residents by staff qualified to deliver it? •

Do management and staff understand what are the key achievements and challenges faced by the home?

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How comprehensive is the induction programme given the residentpopulation’s needs?

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Does the home match staff to residents?

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Is there a clear process and timetable for the auditing of staff training , performance, appraisals and PDPs (this includes mandatory training and training for volunteers)?

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Is there a comprehensive system in place to review and implement needs assessments?

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Is the regulated activity being undertaken in a manner to ensure the financial viability to achieve aims / objectives set out in ‘statement of purpose’?

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Meeting eating and drinking needs

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How does the home ensure staff meet these needs and encourage independence in residents?

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Do staff understand their responsibilities in this area?

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Access to healthcare •

Do all residents have a personal plan and is there a robust procedure in place to ensure its review?

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Are relevant referrals made in a timely manner and are staff aware of their responsibilities in this regard?

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Are there clear up to date policies in place regarding referrals?

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Are there suitable joint local policies in place with external agencies?

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Are staff aware of these policies?

IS IT CARING? Caring: regulatory framework Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 •

Regulation 10 – Dignity and Respect

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Ensure privacy, dignity and respect of service user –

NB 1: Identify and maintain dignity and privacy at all times (including during treatment, care and discussions)

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NB 2: Any surveillance by home must be in best interests of residents and safety of staff and in line with guidance.

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Support autonomy

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Protect human rights / absence of discrimination –

cf Equality Act 2010 for list of protected characteristics


Regulation 20 – Duty of Candour –

Must act in open and transparent way with relevant persons in relation to care and treatment provided

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Where notifiable safety incident has occurred then notify relevant person as soon as is practicable

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Provide support, account, apology, advise of further enquiries and keep written records 

NB 1: Provide step by step account of relevant facts known about incident – should be jargon free and explain any difficult terms

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NB 2: Provide reasonable support to relevant person to help overcome the impact of the incident

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Notifiable safety incident 

Death of service user – where death relates directly to incident rather than natural cause

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Severe harm (permanent lessening of bodily, sensory, motor, physiological or intellectual functions)

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Moderate harm – moderate increase in treatment and significant (but not permanent) harm

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Prolonged psychological harm (>28 days)

Family and residents – is it caring? •

Residents are treated without dignity

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Staff do not seem to care

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Management does not seem to care

The residential home management: immediate issues to address – caring? •

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Privacy and dignity –

Ensure staff are aware of their duties under the Data Protection Act 1998 - can we show the residents’ records to the family members?

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Reminder to staff that they must treat residents in caring and compassionate way

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Reminder to staff that they must not leave residents in neglected or undignified circumstances

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Remind staff that residents must not unnecessarily isolated e.g. they should not be left in their rooms (unless they wish to stay there)

Being open and honest with residents and families –

Have we complied with the duty of candour?

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Do the staff understand what the duty is and their obligations under this?

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Ensure the home has a policy on the duty of candour, that it is up to date and staff have received the appropriate training

CQC inspection: is it caring? •

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Staff kindness and knowledge of residents who feel that they matter and their needs are understood •

How is this encouraged by the home and by employees?

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What practical steps are taken to relieve distress and discomfort?

Privacy and dignity •

Is this promoted within the team / how does management ensure staff understand this?

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Is storage and access to residents’ medical records appropriate?

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Is the care provided with the involvement of residents and, where appropriate, their families?

Being open and honest with residents and families •

Is there a culture of openness, honesty and candour at all levels (including board)?

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How is this culture promoted and how is compliance monitored (including by the Board)

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Are there policies to encourage candour and what are the processes in place to ensure staff follow these?

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How does the home deal with breaches of duty of candour?

IS IT RESPONSIVE? Responsive: regulatory framework Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 •

Regulation 9 – person-centered care –

Is it appropriate, meets needs and reflects preferences? 

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NB 1: Do all that is reasonably practicable to deliver person-centered care – if this is not possible, then explain to the resident and allow them to consider their options in informed manner

Assessment of needs and design appropriate care package 

NB 1: Care and treatment needs and preferences must be assessed by persons with the appropriate skills, qualifications and knowledge

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NB 2: Take in to account residents’ wishes, health, personal care, social, cultural, religious and spiritual needs

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NB 3: Comply with requirements of Mental Capacity Act 2005 where resident lacks capacity (best interests decisions)

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NB 4: Take into account issues common across certain groups e.g. dementia in older persons


Regulation 16 - receiving and acting on complaints –

Investigation and necessary and proportionate action being taken

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Accessible system for identifying, receiving, recording, handling and responding to complaints by residents and other persons related to the carrying on of regulated activity 

NB 1: complaints can be made verbally or in writing

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NB 2: information must be available to complainant about how to complain and escalation of complaints – provide support to complainant throughout process

Family and residents: is it responsive? •

You’re not providing personalised care - residents’ needs do not appear to be assessed properly or reviewed

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Nobody takes our complaints seriously – things are going from bad to worse

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What have you been doing about this – this has been going on for a long time?

The residential home management: immediate issues to address – responsive? •

Personalised care adapted to individual’s needs –

Ensure all personal plans up to date

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Ensure care plans are regularly reviewed (with family / residents) and document / implement response to outcome of review

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Can we evidence regular auditing of care plans?

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Address reasons why staff do not appear to be following the plans

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Ensure care plans are available to all relevant staff at all times

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Responding to complaints –

Ensure complaints policy is in place

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Ensure staff know how to respond upon receipt of complaint and acknowledge complaints

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Establish appropriate level of investigation required in response to families’ complaints and ensure the appropriate investigations are now undertaken

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Ensure staff address respond immediately and appropriately to failures identified in their complaints

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Ensure staff respond to families without delay and advise of the status of the complaint (and of any changes to its status)

CQC inspection: is it responsive to residents’ needs? •

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Personalised care adapted to meet needs of vulnerable persons •

Can the home evidence its policy in relation to care plans and needs assessments?

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Does the policy reflect latest legislative requirements and national guidance?

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Can the home evidence up to date care plans and regular needs assessments?

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Can the home demonstrate that it implements nationally recognised evidence –based guidance in designing, delivering and reviewing care?

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Are the care plans accessible to all relevant staff?

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To what extent are residents involved in the development / delivery of care plans? Are they provided with all the requisite information to permit fully informed choices?

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Can the home demonstrate compliance with the ‘best interests’ provisions of the Mental Capacity Act 2005 where they are engaged?

Does the culture of the home encourage feedback from residents, families and staff? •

Can staff demonstrate knowledge of feedback processes?

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How are concerns recorded by management and fed back to staff?

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Is feedback treated as an opportunity to learn and improve?

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Are staff aware of and adhere to their professional and regulatory duty to be honest and open?

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Does the home maintain a register of complaints and is this reviewed regularly to improve services?

IS IT WELL-LED? Well-led: regulatory framework Registered manager provisions CQC (Registration) Regulations 2009 •

Regulation 5 – registered manager condition –

Requirement to have a registered manager in place where service provider is a body corporate / incorporate


Regulation 7 - Registered Managers –

Good character (Schedule 4, Pt 2) – conviction or struck of professional register

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Sufficient health to undertake regulated activity

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Necessary qualifications, competence, skills and experience of Partners to undertake the regulated activity; and

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Can satisfy criteria of Schedule 3 – documentation re: employment history and criminal record checks


Regulation 14 – notice of absence -

Where registered manager is absent from managing the regulated activity for 28 days or more, the CQC must be informed (usually 28 days before this occurs) in writing with details re: duration, reasons, provisions in place for ongoing management, name, address and qualifications of person responsible for managing regulated activity and arrangements to be made for appointing another person to manage the regulated activities.

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If absence is due to an emergency, then within 5 days of the absence occurring.

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Regulation 5: - notice of changes

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Give notice in writing to CQC as soon as is reasonably practicable of the following:

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Registered manager ceases to manage regulated activity

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Person other than registered manager is managing regulated activity

Governance by service provider Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 •

Regulation 4 – Fitness of Partnership and Partners –

Fitness of individual Partners - good character, sufficient health to undertake regulated activity and can satisfy criteria of Schedule 3

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Fitness of Partnership – combined qualifications, competence, skills and experience of Partners to undertake the regulated activity

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NB: these provisions apply to 

Providers who are not individuals or partnership

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Board members, senior managers, governors sitting on foundation trust board

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For NHS bodies, to executive and non-executive, permanent, interim and associated positions.

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Equivalent director posts in other providers e.g. trustees of charitable bodies


Regulation 6 – Provider is not Partnership –

Similar provisions to Regulation 4


Regulation 5 – Fit and proper persons (directors / equivalent function) –

Of good character (honest, trustworthy, reliability and respectful)

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Has necessary qualifications, competence, skills, experience necessary for the role 

NB: where specific qualification is required, only appoint persons with that qualification

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Healthy enough to perform the role after reasonable adjustments are made

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Has not been responsible for, privy to, contributed or facilitated serious misconduct or mismanagement (unlawful or not) in providing regulated activity (or something that would be a regulated activity if performed in the UK)

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NB: no time limit in relation to serious misconduct / responsibility for failure in previous role

Is not ‘unfit’ as per Schedule 4, Part 1 (bankruptcy / barred list maintained under s2 Safeguarding Vulnerable Adults Act 2006 / barred from holding the relevant office or conducting regulated activity) 

NB: Bankruptcy and convictions may be considered spent after appropriate period of time


Regulation 17 – good governance –

Systems and processes established to effectively monitor and ensure compliance with the HSCAR 2014 regulations, enabling the registered person to: 

Assess, monitor and improve quality and safety of services

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Assess, monitor and mitigate risks of health and safety / welfare

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Maintain accurate, complete an contemporaneous record for each service user (including record of care and treatment provisions and decisions taken)

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Maintain records re employees and management of regulated activity

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Record and act on feedback – evaluation and improve services and feed back to staff and service users

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Evaluate and improve services based on assessment and monitoring processes –

NB 1: Recruit expert advice where necessary and appropriate.

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NB 2: All information must be up to date and accurate


Regulation 16 – notification of death of service user –

Immediate notification of CQC of death of service user whilst services are provided in the course of regulated activity

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Notification must include description of circumstances of the death

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Where death occurred, and where the death was not attributed to resident’s illness or medical condition (unless reported as part of NPSA alert)

Family and residents: is it well-led? •

“Do you know what’s going on here?”

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“Who’s in charge?”

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“Do the staff know what they’re supposed to be doing?”

The residential home management: immediate issues to address - well-led? •

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Good management and leadership – has the home been suitably managed? –

Have we notified the CQC that Mr Minton has left?

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Do we need a registered manager?

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Is Mr Troop a suitable ‘stand in’ (what has he been doing in the last two years)?

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Has head office sufficiently attended the home in the meantime?

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What checks have been undertaken by head office?

Delivery of high quality care –

Family complaints - have we been told about these issues in the past and what have we done to address these concerns and respond to the families?

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Ensure staff are aware of their responsibilities to deliver high quality care and what we expect of them – take remedial action where required

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Ensure the relevant information has been shared with other organisations (including the coroner, safeguarding boards and the CQC)

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Ensure staff are aware of processes in place and obligations to share information

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DO NOT FORGET – EVIDENCE ACROSS FIVE DOMAINS IS VITAL!

CQC inspection: is it well-led? •

Good management and leadership - general points •

Is there evidence of sufficient visibility of leadership inspiring staff to deliver quality service?

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Who is the registered manager and do they understand the challenges faced by the home? Can they explain how these challenges will be tackled immediately and in the long-term?

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What is the registered provider doing to ensure the home is being run appropriately and assure themselves of the quality and safety?

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Is there a shared understanding (of staff) with the management team of challenges faced by the home what is expected of them?

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Can the home evidence its programme and policies addressing staff support and development?

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Are there clear accountability processes for staff?

Good management and leadership – fitness to practise of Directors Can the service provider demonstrate: •

The directors are of good character / deemed suitable for their role – can this be evidenced? If not, confirm action to be taken to investigate and rectify?

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Suitable processes for assessing and checking the suitability of candidates including leadership skills, caring and compassionate nature?

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Its awareness of various guidelines that cover value based recruitment, appraisal, development and disciplinary action including dismissal of directors?

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Processes in place to assure themselves person has not been responsible for, privy to, contributed to or facilitated in any way serious misconduct or mismanagement of carrying on of regulated activity?

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Processes that are in place to determine whether director is implicated in breach of health and safety requirement (as a result of structure of organization and manner in which activities are organized)

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It will take appropriate and timely action to investigate and rectify findings of unfitness or other breaches?

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The regular review and assess fitness of directors (frequency of reviews is determined by the service provider)?

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Robust processes in place to respond to concerns regarding fitness, and investigate in a timely and appropriate manner?

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Where concerns are substantiated, proportionate and timely action are taken?

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Delivery of high quality care •

Governance processes that monitor compliance with regulatory processes is there adequate scrutiny and responsibility at the Board level?

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Can the home evidence quality assurance processes that demonstrate the regular review of policies to ensure ongoing compliance with regulatory

requirements (including registration requirements) and evidence the implementation of nationally recognised and current guidance?

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Do the assessment systems adequately involve and take into account residents’ experiences?

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Can the home demonstrate how the analysis of assessments is translated into effective actions?

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Is there evidence of staff awareness of risks compromising quality?

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Can the home evidence robust records and data management systems?

Effective working with external agencies (e.g. safeguarding teams) •

Are there effective processes in place that ensure the timely referral to external organisations?

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Are there local policies in place to this effect?

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Are staff aware of their obligations to work effectively with external organisations and how they are expected to do this?

CHALLENGING THE CQC REPORT Tactics during the inspection •

Confirm expertise of inspectors!

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Discrete observation of inspector and note taking (says / does) –

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‘Sit in’ during interviews – ask permission of ‘interviewee’ first

List documents reviewed and any refusals to consider by the inspector –

Send documents to inspector and area manager within 24 hours of inspection with explanation of failure to consider

•

In only the most extreme circumstances – stop inspection but be prepared to defend potential allegation of obstruction (make a strong and detailed note of the visit, issues of concern, and why the inspection could not continue)

•

Request confirmation of issues considered under each regulated activity – ensure compliance request relates to that regulated activity (and is not spread across several activities)

•

Is inspector asking you to do something not specified by the regulations?

•

Confirm if an indicated expectation is unrealistic

•

Ensure the CQC inspector provides you with a written note of feedback

•

Take your own notes during the feedback session

•

Ensure you provide all relevant documentation to the inspector on the day or afterwards if you think of things you should have given them.

Reviewing the report •

Review line by line - preferably in a small team (different perspectives and input)

•

Difficult to challenge any enforcement action taken by CQC if report is not challenged

•

Ensure comments can be supported e.g. documentary evidence

•

What sort of inaccuracies in a report can be challenged? –

Factual inaccuracies only? No.

–

Judgment and factual inaccuracy are inextricably linked

–

Misleading information - context is everything!

–

Negative working / connotations

–

Imprecise wording

•

Press CQC to clarify matters

•

Has CQC acted beyond its powers? –

E.g. attempts to make guidance into legally binding compliance actions

•

Ensure factual accuracy report is submitted by the deadline

•

What types of factual inaccuracies can you challenge?

•

Some examples of clarifications that should be made in reports… –

Confirm whether observations are in line with expected practise

–

Confirm whether facilities / equipment are available but not used by the staff

–

Confirm whether ‘allegations’ have been corroborated by investigations or references to records, minutes of meetings

–

Set numbers / statistics cited by CQC into their correct context

–

Ensure the report includes remedial actions that have either been taken or are effectively being put in place

–

Is the evidence provided within the report sufficiently triangulated i.e. robust?

Next steps •

•

Action plans –

Consider fully in light of your review of the report

–

Submit as soon as possible for those aspects of the report that are unchallenged

–

May otherwise be seen as an admission of breach of regulations

Issues with the inspectors? –

Take ‘witness statements’ from persons subjected to rude, intimidating or inappropriate behaviour by inspector

–

Complain as early as possible and before publication of draft report

–

Errors of judgment?

–

Irrational behaviour?

–

Refusal to look at key documentation and the deliberation misinterpretation of comments?

–

Disrespectful language and intimidating demeanour?

–

How to complain? Stage 1 of CQC complaints procedure

–

Otherwise, challenge report within 10 working days of receipt (with supporting documentation)

OTHER REGULATORY CONSIDERATIONS •

Reporting of Injuries Diseases and Dangerous Occurrence Regulations 2013 (RIDDOR) –

Regulation 6: Work-related fatalities

–

(1) Where any person dies as a result of a work-related accident, the responsible person must follow the reporting procedure (with the exception of suicide).

–

NB: Includes deaths arising as the result of an act of violence to worker or nonworker

–

Regulation 5: Non-fatal injuries to non-workers

–

Where any person not at work, as a result of a work-related accident, suffers—

–

(a) an injury, and that person is taken from the site of the accident to a hospital for treatment in respect of that injury

•

RIDDOR and inquests: Coroners and Justice Act 2009 –

Section 7: Whether jury required

–

Ss1: An inquest must be held without a jury unless…

–

Ss2(c): that the death was caused by a notifiable accident, poisoning or disease

–

Ss4:… an accident, poisoning or disease is “notifiable” if notice of it is required under any Act to be given—

–

(a)to a government department, .

–

(b)to an inspector or other officer of a government department, or .

–

(c)to an inspector appointed under section 19 of the Health and Safety at Work etc. Act 1974 (c. 37).

Information governance: Data Protection Act 1998 [for living persons only] •

S2: Sensitive personal data…(e) physical or mental health or condition

•

Schedule 1 – The Data Protection Principles

•

•

•

•

1. Fair and lawful processing of sensitive personal data requires at least condition from Schedule 2 and at least one condition from Schedule 3.

•

3. Personal data shall be adequate, relevant…

•

4. Personal data shall be accurate and, where necessary, kept up to date

•

6. Personal data shall be processed in accordance with rights of person

Schedule 2 – •

1. Person has consented to data being disclosed

•

4. Necessary to protect the vital interests of the person

Schedule 3 •

1. Explicit consent has been provided by person

•

3. The processing is necessary to protect the vital interests of person where a) consent cannot be given by them or on their behalf, or b) the data controller cannot reasonably be expected to obtain the consent of the data subject.

Common law provision •

•

Public interest – protect person from risk of serious harm

Access to Health Records 1990 [for deceased’s persons only]

•

•

•

•

S3: Right of access to health records…By personal representative and any person who may have a claim arising out of the patient’s death

Health and Safety at Work etc. Act 1974 –

Section 2. General duties of employers to their employees

–

(1) It shall be the duty of every employer to ensure, so far as is reasonably practicable, the health, safety and welfare at work of all his employees.

–

Section 7. General duties of employees at work

–

It shall be the duty of every employee while at work—

–

(a)to take reasonable care for the health and safety of himself and of other persons who may be affected by his acts or omissions at work; and

–

(b) as regards any duty or requirement imposed on his employer or any other person by or under any of the relevant statutory provisions, to co-operate with him so far as is necessary to enable that duty or requirement to be performed or complied with.

Management of Health and Safety at Work Regulations 1999 –

Expands upon the general duties as per the HSW Act 1974

–

Duties to undertake risk assessments

–

The effective planning, organisation, control, monitoring and review of health and safety

–

Health surveillance (where there is an identifiable disease or adverse health condition related to the work)

–

Appointment of competent persons to meet legal requirements

–

Provision to employees of comprehensible and relevant information in relation to the risks to their health and safety and preventative/ protective measures to be taken

–

Taking into account abilities of employees to perform certain roles

–

Responsibility of employees to report hazards to employers

Corporate Manslaughter and Corporate Homicide Act 2007 –

Section 1: Organisation is guilty of an offence if the way in which its activities are managed or organised [by its senior management] causes a person’s death and amounts to a gross breach of a relevant duty of care owed by the organisation to the deceased.

–

Includes corporations and partnerships

•

•

–

Senior management includes persons involved in making decisions about how the whole / substantial part of how activities are organised / managed, or their actual management or organisation

–

Management / organisation is a substantial element of breach of duty

–

A “gross” breach occurs where the conduct alleged to amount to a breach of that duty falls far below what can reasonably be expected of the organisation in the circumstances

Gross negligence manslaughter (common law provision) –

Main case: R v Adomako (1994) 3 All ER 79

–

A duty of care to the deceased exists; and

–

That duty is breach (by an otherwise lawful act or omission); and

–

The breach causes (or significantly contributes) to the death of the victim; and

–

The breach should be characterised as gross negligence, and therefore a crime.

Occupiers Liability Act 1957 –

•

Section 2: an occupier of premises owes a “common duty of care”, to all his visitors… take such care as in all the circumstances of the case is reasonable to see that the visitor will be reasonably safe in using the premises for the purposes for which he is invited or permitted by the occupier to be there.

Doctrine of vicarious liability of employers for actions of staff conducted during the course of their employment –

Claims by residents

–

Claims by family and estate (if resident is deceased)

–

By staff as a result of deficient working processes or actions of colleagues

PENALTIES Registration and CQC regulations Section 33: Health and Social Care Act 2008 •

Failure of registered person to comply with condition of license for regulated activity

•

Without reasonable excuse

•

Offence – maximum fine £50,000

•

FPN – provider £4,000 / registered manager £2,000

Regulation 25: The Care Quality Commission (Registration) Regulations 2009 •

Failure to comply with regulations 12, and 14 – 20 – criminal offence

•

Summary conviction – fine £2,500 (level 4)

•

FPN - £1,250 (service provider)

Provision of false information Sections 92 and 94: Care Act 2014 For example, during registration or during inspection by CQC •

S.92 offence: for a care provider to supply or produce false or misleading information where it is required under statute or any other legal obligation –

Must false / misleading in material respect

•

S.92 defence: all reasonable steps taken and all due diligence exercised to prevent the provision of false or misleading information

•

S.94 where s.92 offence committed by body corporate and offence is committed by, or with the consent or connivance of, or is attributable to neglect on the part of director (or some similar such post / capacity)

•

S.93 – penalties upon conviction

•

–

summary conviction – fine

–

indictment - imprisonment for not more than two years or a fine (or both)

Court may also (as well as or instead of imposing a fine) make a remedial order or publicity order

Contractual duties •

Check your contract carefully

•

Rights of commissioners of services under terms of contract

•

Financial penalties

•

Adverse publicity – requirement to notify public of breaches

•

Notify CQC of failure under terms of contract

Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Criminal offences •

Some regulatory breaches are criminal offences –

Beyond all reasonable doubt

– •

Privilege to avoid self-incrimination

CQC can prosecute directly – sanctions on conviction: –

Potential fines up to £50,000

•

Adverse media interest

•

CQC must use powers proportionately

•

Criminal sanctions in most serious cases only –

Serious and willful non-compliance

–

Fixed penalty notices instead (“FPNs”)

•

All regulations will be subject to other forms of CQC enforcement

•

Issue warning notice / notice of proposal to impose conditions

•

Impose a condition on registration

•

Nature of failure of registration requirement / steps required to achieve compliance

•

Suspend / remove registration

•

Impact upon rating by the CQC

Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Breach no harm required •

Direct prosecution without prior service of Warning Notice

•

CQC can take other regulatory action may be taken (besides prosecution)

•

CQC must refuse registration if unable to satisfy ongoing compliance

•

Which regulations does this apply to?

•

Regulation 11- need for consent

•

•

–

Max fine - £50,000

–


Regulation 16(3) – receiving and acting on complaints –

Max fine - £2,500 (level 4)

–

FPN - £300

Regulation 17(3) – good governance

•

•

–

Written report within 28 days of CQC request

–

Assess, monitor and improve the quality of safety and services

–

Max fine - £2,500 (level 4); FPN - £300

Regulation 20(2)(a) & (3)– duty of candour –

Failure to notify /comply with requirements)

–

Max fine - £2,500 (level 4); FPN - £1,250

–

Defence - to show took all reasonable steps and exercised all due diligence to prevent the breach

Regulation 20A – requirement to display performance assessments –

Breach of any part of this regulation

–

Max fine - £500 (level 2)

Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Breach with avoidable harm Breach with avoidable harm •

Breach must result in people who use services being exposed to

•

avoidable harm; or

•

significant risk of such harm occurring; or

•

suffering a loss of money or property as a result of theft, misuse or misappropriation

•

Other regulatory action may be taken (besides prosecution)

•

CQC must refuse registration if unable to satisfy ongoing compliance

•

Which regulations does this apply to?

•

Regulation 12 – safe care and treatment (any part of regulation)

•

–

Max fine - £50,000

–


Regulation 13 – Safeguarding from abuse and improper treatment –

Breach of 13(1) – 13(4)

–

Max fine of £50,000

–


•

Regulation 14 – meeting nutritional and hydration needs (any part of regulation) –

Max fine of £50,000

–


Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Standards without prosecution •

Regulation 9: Person centered care

•

Regulation 10: Dignity and respect

•

Regulation 15: Premises and equipment

•

Regulation 18: Staffing

•

Regulation 19: Fit and proper employees

•

Regulation 5: Fit and proper director

•

CQC can take regulatory action under its enforcement policy.

•

CQC must refuse registration if providers cannot satisfy CQC that they can and will continue to comply with this regulation.

Health and Social Care Act 2008 (Regulated Activities) Regulations 2014: Directors – fit and proper persons? •

Breach of Regulation 5 – not an offence under the 2014 Regulations

•

S91 Health and Social Care Act 2008 –

•

•

Where an offence is committed with the consent, connivance or attributable to the neglect of a director, manager or secretary of the body corporate (or someone purporting to be acting in that position) then they will be guilty of an offence and “prosecuted / punished accordingly”

Some breaches of FPPT regulation may become offences if caught under other regulations –

E.g. Reg 17 - offence not to provide CQC with information requests in relation to governance processes

–

E.g. Reg 16 - offence not to provide CQC with information it requests in relation to a complaint

Civil steps –

Impose conditions to ensure removal of director who is not ‘fit and proper’

–

Impact upon rating by the CQC (e.g. whether a provider is ‘well led’)