PIR guidance: Quality assurance and risk management

Page last updated: 12 July 2022
Categories
Organisations we regulate

Infection prevention and control

How do you minimise the risk of infection at your service?

This is about all types of infection. Include things that you have learnt from the coronavirus (COVID-19) pandemic.

Quality assurance

This section is for Shared Lives services only.

There should be regular health and safety risk assessments of premises (including grounds) and equipment. The findings of these assessments must be acted on without delay if improvements are required. As part of monitoring, it is essential that there are assurances that premises and equipment are assessed as fit for purpose in between inspections.

Shared Lives Scheme Panel

We will not ask you these questions if you do not operate a Shared Lives Scheme Panel.

Panels have an important role in quality assuring the assessment process - monitoring and reviewing the work of assessors; providing and feeding back on the quality and consistency of assessments and Shared Lives processes. If you Shared Lives Scheme has a panel, provide details of how this is being done.

Does your scheme have a panel?

This is a yes or no answer.

Schemes with a Shared Lives Scheme Panel only
How many panel meetings have been held in the past 12 months?

Count all meetings that have been held in the 12 months up to the date of this return.

Schemes with a Shared Lives Scheme Panel only
How many Shared Lives carers have been approved by panel in the past 12 months?

Count all approvals granted in the 12 months up to the date of this return.

Schemes with a Shared Lives Scheme Panel only
How many Shared Lives carers have been de-approved by panel in the past 12 months?

For de-approvals, state the number of Shared Lives carers that the panel have removed carer approval from.

Schemes with a Shared Lives Scheme Panel only
Describe how carers are assessed and approved.

There is no further guidance.

Schemes with a Shared Lives Scheme Panel only
What reasons have there been for the panel to remove carers' approval status?

Give reasons for carers whose approval status was removed in the 12 months up to the date of this return.

How do you quality assure your scheme?

If a panel is not in place, provide details of how these functions are currently being managed.

Duty of candour

How many notifiable safety incidents have you had in the past 12 months that have triggered the harm thresholds of the duty of candour regulation?

Medicines and controlled drugs

Specialist staff support inspection teams to ensure that services are providing medicines in a safe and effective manner. The following questions help to provide context with what requirements are made of the service’s staff when administering medication.

Remember: All questions on this form relate to the service you provider for people receiving regulated activities, such as personal care, and to staff and other people delivering regulated activities. Do not include any information about people and staff who do not receive or deliver regulated activities.

Do you administer medicines?
Shared Lives: Do any Shared Lives carers in the scheme support people to take their medicines?

Answer 'yes' if you administer drugs to people receiving regulated activities.
(If your service does not administer medicines, medicine-related questions will not appear.)

Have you administered controlled drugs in the past 12 months?
Shared Lives: Have any Shared Lives carers in the scheme supported people to take controlled drugs in the past 12 months?

A ‘controlled drug’ is any medicine listed under the schedules defined by the Misuse of Drugs Act 1971. By ‘administer controlled drugs’ we mean that you hold, store or give these to people receiving regulated activities at your service.

This is a yes or no answer.

Have you administered medicines covertly in the past 12 months?
Shared Lives: Have any Shared Lives carers in the scheme administered medicines covertly in the past 12 months?

A person has the right to refuse treatment including medicine. If medicines are being administered covertly they are given disguised in food or drink and it can only be authorised if the person lacks capacity to understand the consequences of not taking the medicine.

This is a yes or no answer.

How many people have been given medicine as a form of restraint or to control behaviour in the past 12 months?

Chemical restraint is the use of a medicine which is prescribed and administered for the purpose of controlling or subduing disturbed/violent behaviour, where it is not prescribed for the treatment of a formally identified physical or mental illness. Chemical restraint is unlawful unless justified for purposes set out within the legal framework. Chemical restraint should only be used as part of an agreed support plan and should be delivered in accordance with evidence-based best practice guidelines and by staff with the relevant qualifications, skills and experience to administer it.

Psychoactive medicines, or psychotropic substances are often used as a chemical restraint. These are chemical substances that alter brain function, resulting in temporary changes in perception, mood, consciousness and behaviour. These include groups of medicines such as antidepressants, antipsychotics, antiepileptics, mood stabilisers (including sodium valproate and carbamazepine), anxiolytics (benzodiazepines), and central nervous system stimulants.

How many of the people who take prescribed medicine have not had a medication review with a GP or other suitable healthcare professional in the past 12 months?

For Shared Lives schemes, this question is about people in the scheme who have support with their medicines.

A medication review:

  • is a structured, critical examination of a person’s medicines by a healthcare professional
  • includes the persons’ views and understanding about their medicines
  • where appropriate, includes family members or carers
  • answers concerns, questions or problems with the medicines, including side effects or reactions
  • should occur at least once a year but more often if the health and care needs of the person dictate.

Have you used enteral tube feeding to administer medicines in the past 12 months?
Shared Lives: Have any Shared Lives carers in the scheme used enteral tube feeding to administer medicines in the past 12 months?

Enteral feeding tubes provide access to the stomach or jejunum (small intestine).

They are used in cases where there is an obstruction or difficulty in swallowing. Medicines administered via enteral feeding tubes are often done so 'off licence' and have not been designed to be administered this way. Responsibility for giving off license medicine lies with the prescriber, consulting pharmacist and the person/service administering the medicine.

This is a yes or no answer.

How many medicine related errors have there been in the past 12 months?

Providers should have robust processes for identifying, reporting, reviewing and learning from medicines-related problems. Research has shown that where rates of incident reporting are high there is more likely to be a better culture of safety and risk management.

We would like you to include the number of medicine errors that have occurred in the 12 months up to the date of this return. The following are examples of errors (non-exhaustive list):

  • not recording when you have administered medicines, for example not signing MAR charts
  • not recording why doses have been missed
  • using the wrong key code for non-administration
  • signing for medicines you have not administered
  • inaccurate or unclear records
  • not enough information to administer medicines safely, for example instructions about taking medicines with or after food
  • a dose has been missed
  • too much or too little of the medicine was given
  • the wrong medicine was given
  • it was given to the wrong person
  • it was administered in a manner that did not follow your medicines procedure or prescribing requirements.

Count every single incident.

How many of these involved controlled drugs?

A ‘controlled drug’ is any medicine listed under the schedules defined by the Misuse of Drugs Act 1971. We would like you to include the number of medicine errors that have occurred in the 12 months up to the date of this return. Errors could be in relation to ordering, storing, recording, prescribing, administering and destructing controlled drugs.

We will only ask you this question if you have administered controlled drugs in the past 12 months.

Count every single incident.

Complaints

These questions help us to review how effectively complaints are handled and to evidence to what extent concerns and complaints are used as an opportunity to learn and drive continuous improvement.

We recognise that high numbers of complaints may not indicate a poor service, but instead that people feel safe to give their feedback.

All complaints included should be recorded and you should be able to show us these records and any received in writing.

In the past 12 months, how many complaints were made about your service that were managed under your complaints procedure?

Count all complaints made in the 12 months up to the date of this return.

What are the main complaints you have received in the past 12 months and what have you changed as a result to improve your service?

Give specific examples of action you have taken which has resulted in making a difference for the people involved.

Records

How are you assured that those you employ and deploy within your service have had their required vaccinations?

This question is for residential services only.

Since 11 November 2021, registered persons of all CQC registered care homes have been required to ensure that they only deploy people, and allow entry to visiting professionals, within the premises who have been fully vaccinated against COVID-19 (unless exempt). This applies to services registered with CQC for the regulated activity of providing accommodation together with nursing or personal care and is subject to certain exemptions. This question is asking how you assure yourself that this requirement is met. The requirement forms part of the fundamental standards and is monitored and enforced in appropriate cases by the Care Quality Commission. The requirement is part of the Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) Regulations 2021 (‘the Regulations’). Further information is available in the DHSC operational guidance.

Do you currently use a digital social care record system (DSCR) at your location?

A DSCR allows the digital recording of care plans and care received by an individual.

We would like to know if you operate a digital social care record system (DSCR) at this location; you might know this better as an electronic care plan. This question helps us to understand the level of adoption of DSCRs in the social care sector. These systems will also allow you to send information and generate reports more easily helping you to demonstrate quality assurance and risk management where requested by a CQC inspector. (Yes/No)


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