The 28 Essential Guidance /Outcomes have now gone!

This section is here as a record of history. Scrapping this approach resulted in countless wasted hours with every provider having to scrap systems organised around the 28 Outcomes and start all over again.

From 1st October 2014, Providers are required to follow new KLOEs based inspection regime.

Archives

The 28 Essential standards guidance published by the CQC came under criticism not only from the Health Committee, but also from the House of Commons Public Accounts Committee and from within the CQC's own board.

In the report published on 09 January 2013 "The Committee concluded that the CQC's primary focus should be on ensuring that the essential standards it enforces can be interpreted by the public as a guarantee of acceptable standards in care. We do not believe that the CQC's essential standards in their current form succeed in this objective."

Commenting on the Health Select Committee report, Chief Executive David Behan has outlined CQC's "intentions to tailor the way we regulate different types of organisations based on what has the most impact on driving improvement." He continued that, "We have already begun to make some of these changes and will continue this process."

In fact, the actual Regulations are quite straightforward in that they specify what you should comply with and do not refer to the requirements in terms of outcomes.

The CQC is required to produce guidelines to help providers understand the regulations. What the CQC has attempted to do is produce a definitive document combining the Registration Act with the Regulations, and the result is the 278 page document titled "Care Quality Commission - Guidance about compliance".
The CQC believes that the process should be outcomes orientated and has reordered the various paragraphs of the regulations as outcomes 1 to 28.

Here are some problems with these guidelines:

• Most providers find it a very difficult read because of the bureaucratic language used
• It introduces the concept of "prompts" which have no legal basis, but will nevertheless be used to judge compliance
• The same prompts may appear under several Outcomes, so presenting evidence in the same sequence as the Outcomes becomes problematic
• Compliance with CQC does not mean you are compliant with everything. The guidelines have some glaring omissions and also state that they are not intended to cover everything.

 In these sections, we have tried to simplify the meaning of the Outcomes.

Why no one reads the Outcomes

CQC Regulations came into force from 1st April 2013, and CQC inspections are underway; however it is considered that up to 95% of practices may not have read the CQC Guidelines yet.

The registration process asked practices to certify that they meet the compliance standards set under the CQC regime, and practices are required to have made themselves familiar with the CQC Guidelines issued by the Care Quality Commission.

Although every practice has certified that they are compliant or that they have an action plan in place, alarmingly, anecdotal evidence suggests that up to 95% of Practice managers may not even have read the CQC guidance.

“We were the first independent organisation to hold CQC seminars for GP practices, and when we asked this question in 2011, hardly any hands went up” said Shabana Dehlavi, the editor of Everything CQC, the popular CQC resource site for GP Practices. “But what will be surprising to many is that the same applies, even today”.

If these straw polls were to be extrapolated to the general GP population, it would indicate that up to 95% of the practices have not read the Guidelines or gave up part of the way through, usually after reading just the first few pages. So if you too have not read the CQC Essential Guidance then it looks like you are in good company.  
Most providers find the Guideline a difficult read because of the ‘bureaucratic’ language used.  Trying to ‘decipher’ the meaning of a single sentence can sometimes take quite some time, and most just give up mentally exhausted.

An example of this language is Prompt 3E about Fees, to be found on page 59 of the Guideline.

Contrast what the Guideline says:

“People who use services who pay the provider in full for their care, treatment and support and people who use services who enter into a separate arrangement with a service provider because they choose to pay for care, treatment and support that is not contracted on their behalf by a third party purchaser…”

With what it means in plain English:

“If the patient pays for the entire treatment out of their own pocket, then …...”

The Guideline, is some 278 pages long, and it is not difficult to see why readers describe it as a cure for insomnia.

On a serious note, without a full understanding what the requirements are, practices are in danger of mis-declarations, and carrying on doing the wrong things for the rest of the year. This should be of great concern to GPs, especially Registered Managers, who may be held accountable.

The NAPC supports this resource, and members who are concerned should make a bee line for www.EverythingCQC.com as this plain English guide is designed to educate and inform, and explains once again in plain English, the easiest and most painless route to keeping the house in order.

The 16 core essential outcomes:

(To print a Quick Guide to the 28 outcomes CLICK HERE)

Contrary to popular belief, CQC is actually nothing new. Most of the regulations have been in force for some time. We have done a quick graphic below to stop you having palpitations.

As we explain further on, the biggest change is that the emphasis is moving towards proving that you are meeting compliance on a day to day basis, rather than just knowing what to do.

The Regulations and the CQC Guidelines are two completely separate things.

The guidelines are exactly what they say on the tin, they are "guidelines" only. These then try to suggest how you could meet the regulations by listing out a series of "Prompts" and again the clue is in the wording used.

Here is a quote from the Guidelines:

The legal status of our guidance for providers
"Although we must take it into account when making decisions about a provider’s compliance with the regulations and in tribunals and courts, the guidance is not enforceable in its own right."

A prompt is simply a suggested way you could meet the regulations and are not the definitive list of things you need to do. For example, the guidelines completely omit to mention the NHS Complaints regulations of 2009, but just because they have forgotten it does not mean you can ignore this as well.

Here are extracts from the Guidelines:

Other relevant legislation
".....we consider to be of particular importance, but we have not included all relevant legislation."

"As a provider of care, you are responsible for knowing what other legislation is relevant to your service and making sure that you comply with it. We may consider your compliance with such legislation as part of the way we monitor and check your services."

As a business, you have to meet the CQC regulations as well as any other legislation that applies to you

Contrary to popular belief, CQC is actually nothing new. Most of the regulations have been in force for some time. We have done a quick graphic below to stop you having palpitations.

As we explain further on, the biggest change is that the emphasis is moving towards proving that you are meeting compliance on a day to day basis, rather than just knowing what to do.

Summary

Patients understand the care and treatment choices available to them. They should be able to express their views and are involved in making decisions about their care. (Informed Consent)
You should respect their privacy, dignity and independence take their views and experiences into account when prescribing care.

Outcome in plain English

1A People who use services are involved in their care planning

• Explain and discuss the care and options available to a patient
• Respect a persons rights to make the choice of treatment
• Promote and respect all aspects of their human rights by:
• Putting the needs and preferences of the person at the core of all decisions of their treatment
• Ensure that privacy can be maintained during treatment
• ensure that staff understand the concepts of privacy, dignity, independence and human rights
• Maintain confidentiality
• Listen and involve patient or those acting on their behalf in the treatment  decisions
• Provide information to the patient or carer about their care/treatment and available support
• Ensure that staff understand diversity and human rights
• Make sure patients are aware of independent advocacy services
• Cooperates with independent advocacy services

1B Treatment and support needs of people who use the service is met because:

• They are listened to.
• They, or those acting on their behalf, are involved in the treatment  process
• The patient's preferences are taken into consideration
• Ensure that staff are respectful of the patient's decisions
• Manage risk through effective procedures

1C Follow clear procedures which ensure:

• Patient involvement in their own are and
• The patient's treatment preferences are taken into consideration
• The choices of people who use services are accommodated unless:
• it places other people at risk
• Unreasonable resources are needed to achieve the choice
• It is not a service that you provide
• the patient  does not have capacity to make that decision
• the person is subject to a legal restriction that prohibits them making a choice.
• Treatment and care plans are based on individual needs and choices
• If required arrangements for a carer should be in place
• Reasonable adjustments should be made to involve the person in decision about their treatment

1D Following Guidance

• All relevant guidance applicable to the service should be followed
• Promote rights and choices
• 1E Patient involvement in their own care is supported by
• Giving patients access to information
• Disuses the patients options with them
• understand individual needs
• know the aims and limitations of the service
• Know the choices available to the patient
• be aware of the consequences of the patient's choice
• Be able to advise the patient on the risks and benefits of their choice
• Take into account the urgency of the need for treatment
• Provide information to allow them to make informed lifestyle changes

1F Promote independence

• Involve patient in their own care
• respect patient choice
• Enable informed choice
• Inform them of the risks

1G Respect Human rights and diversity

• Discuss the patient choice
• Provide information
• Ensure that staff understand the concepts of privacy, dignity, independence and human rights

1H Provide details of the Aims and Objectives of your service

• The facilities available for the patient care
• How care plans are reviews
• Inform them of the cost of service
• How to raise a complaint or concern about the service
• Details of the local advocacy service

1I & J Encourage and support patients/careers choices

What the BMA says

Your practice is likely to be compliant if your practice does the following:

Involves patients in their care; for example, by establishing patients needs, preferences and decisions and providing information about the available care, treatment and support options so that patients can make informed decisions.  

1. Provides care with due regard for the patients’ age, sex, religious persuasion, sexual orientation, racial origin, cultural and linguistic background and any disability they may have.
2. If patients lack capacity to make their own decisions, it follows procedures based on the guidance in the BMA’s Mental Capacity Act Toolkit.
3. Knows when to arrange for a patient representative, with the representative being involved in assessment, planning and decisions about the patient’s care.
4. Maintains, respects and manages the privacy of all patients and their records.  

Your practice has the following:

• A chaperone policy.
• A confidentiality and consent policy
• Information from surveys suggesting that patients feel involved in their care
• A patient participation scheme.
• Records that explain when a patient’s preferred treatment cannot be followed (e.g. because their choice would place others at risk of harm, or because services are unavailable).
• A leaflet containing information about your practice’s services.

Summary

This outcome is about informed consent. Patients should give consent to their care and treatment, and understand and know how to change decisions about things that have been agreed previously.

Outcome in plain English

2A Manage risk through effective consent procedures

• If you don't know your patient well, how do you know they can make an informed decision
• Make information simple to understand
• If patient can't understand it, explain it to someone more capable
• Give them time to digest (unless it's an emergency)
• Respect a child's confidentiality if requested by child
• Identify adult/parent/guardian when child can't give consent
• Have a consent procedure for children
• Patients have the right to bring along an advisor
• Explain refused treatment and other options
• Patient can refuse consent or change their mind after consenting
• The Patient may have made a made decision before becoming mentally impaired/incapacitated
• Someone might have applied under the Mental Health Act that the patient is not capable of consent. Find out who does.
• Review consent regularly as patient needs any change from time to time
• Follow special consent procedures in clinical trials and research

2B Your staff should understand:

• When consent is needed
• How to document it
• When verbal consent is OK
• Respect and understand cultural differences
• Be able to provide further help
• Be sure that patients are capable of giving consent
• Give the patient sufficient information to make the decision
• Do what's best for the Patient in emergencies, when it is not possible to obtain consent
• Ensure previous consent has not changed or been withdrawn
• Staff should know what to do when:
• They have to respect decisions even if they disagree
• What to do when what the Patient wants is not in their best interests
• When Patient's decision conflicts with the person acting on their behalf
• How to deal with consent decisions made some time ago
• Dealing with children's consent

2C You need procedures for when a patient can't or won't give consent

• See if Mental Health Act or Children Act apply
• Know the circumstances when previous decisions be lawfully over-ruled
• What to do in an emergency

2D People who use services benefit from a service that:

• Takes into account all relevant guidance on consent

2E What does the Patient need to make the decision

• Patient should be fully informed of pros and cons

2F People who use services give valid consent because:

• Know that cosmetic surgery can't take place on the same day as the advice (impulse decisions)

2G When symptoms DO NOT indicate Imaging is required:

• Tell patient of all pros and cons, including:
• How risky the procedure is
• Risk if results turn out to be incorrect or are not clear

What the BMA says

Your practice is likely to be compliant if your practice does the following:

1. Understands and promotes good practice on consent for adults, children and young people.  

2. Provides information to patients on the care and treatment options available (including the risks and benefits of each option) before they make consent decisions

3. Understands how written consent should be recorded and when it should be taken, i.e. when:

   - a treatment or procedure is complex, or involves significant risks;
   - the procedure involves regional anaesthesia or sedation;
   - providing clinical care is not the primary purpose of the procedure;
   - there may be significant consequences for the patient’s employment, social or personal life;
   - the treatment is part of a project or programme of research.

4. Carries out a regular review of consent decisions to take into account the changing needs of patients.

5. Can identify when a patient lacks capacity to make their own consent decisions. In those circumstances we suggest that your staff follow the guidance in the BMA’s Mental Capacity Act Toolkit.

6. Identifies patients who are under 16 years old. In those circumstances we suggest that your staff follow the guidance in the BMA’s Children and Young People Toolkit.  

Your practice has the following:  

1. A consent policy. You could use the Department of Health’s Model policy for consent to examination or treatment and modify it for your practice. Your staff can also refer to the DH’s Reference guide to consent for examination or treatment.  

2. Information about your consent procedures on display/available (e.g. a practice notice/leaflet).

Summary

This outcome relates to fees charged to patients. There should be transparency in the way fees are charged and the patient must be assisted to make an informed decision about the costs and financial implications.

Outcome in plain English

Follow this good practice to cover everything in this section

Before they sign for treatment you need to inform them of the following:-

• If it's going to cost, tell them up front
• Give them time to think about it
• Don't pressure them

Provide full documents:-

• A proper agreement and time to think about it.
• Statements of account as needed
• Terms and conditions, cancellation terms and effect of non-payment
• A final copy signed by both parties
• Issue receipts for payment

Explain costs:-

• Describe the care ordered by patient/ what they are paying for
• Make sure they have full information on costs
• Make sure everyone knows who has to pay what
• Give estimates if you cannot give fixed price
• Don’t have hidden or unexpected costs
• If additional costs arise, tell them before the treatment
• Give advance notice of increases in prices in case they want to cancel
• Tell them when payments are due and remind them in good time
• How they can make payment

Be knowledgeable:-

• Always read/know relevant guidance and stuff about rights and choices
• Make sure you are well informed to answer all questions

Summary

This outcome is about delivery of care and making sure that the patient experience is that of effective, safe, and appropriate care, and treatment and support that meets their needs and protects their rights.

Outcome in plain English

4A Appropriate care

• Plan the care carefully right from the beginning
• Tailor the treatment to the patient's requirements
• Involve the patient in planning
• Make sure this is what they want
• Tell them what the risks are
• Follow practice on informed consent
• Need regular reviews of this plan in case things change or don't work
• Make sure it is good for the patient all round
• All providers should work as a team to provide the care
• Try not to disrupt their personal life too much
• Remember you are doing this to improve their health
• Try and spot potential health problems early on
• Help them to lead healthy lifestyles
• Make sure your system works

4B Your systems and procedures

• Review your performance and procedures regularly
• Learn from your mistakes
• Tell the patient and apologise if you've messed up
• Act on your alerts
• Try and anticipate emergencies and plan for them
• Who will deal with the emergency and how
• What will you do for backup help

4C Treatment and plans

• Tell the patient who will be treating them
• Help them plan out how to cope on their own after the treatment

4D Staff competency

• Show that you are competent to spot when patients are seriously ill, need treatment and you can respond
• That you will quickly transfer them elsewhere if they need to be

4E Follow practice on informed consent

• Help patients make decisions where help is needed
• Give them full information to make an informed choice

4H Diagnostics

• Diagnostic tests and assessment should be done by suitably qualified staff
• Same applies even in telemedicine

4I Children

• Follow practice on informed consent
• Involve children in the process as far as possible
• Ask if they would like parent or guardian involved

4J Pregnancies and termination

• Follow correct referral procedures
• Provide 24-hour helpline
• Ask their preference on disposal of foetal tissue
• Refer to a trained counsellor
• Where children or persons with learning disability are involved, make sure counsellor has this experience

What the BMA says

Your practice is likely to be compliant if your practice does the following:  

1. Establishes or reviews the individual health needs and risks of all patients when they have an appointment so that they can plan and/or deliver the appropriate treatment.
2. Offers newly registered patients a health check with a healthcare assistant, practice nurse or a GP within six months of registration and provides on request a consultation for any registered patients aged 16-75 that have not attended a consultation in three years.   
3. Has patient plans for care (or similar) that patients (or their representatives) are involved in planning as appropriate and reviewed on an appropriate timescale.
4. Provides lifestyle information to patients when appropriate (see Appendix B3 for a lifestyle information protocol).
5. Conducts regular significant event reviews and analyses and learn from incidents, errors and near misses. We suggest that if there is an adverse event or error during a patient’s treatment you offer an apology and give a full explanation of what happened in accordance with paragraph 30 of Good Medical Practice guidelines.
6. Observes its local incident reporting procedure
7. Arranges for patients to be transferred to the appropriate service when a patient becomes/is seriously ill at your practice.

Your practice has the following:  

1. A protocol for reviewing and acting on correspondence, reports and investigation results.
2. A procedure for disseminating the latest national/local clinical guidance, medical device alerts and safety alerts to staff.
3. A business continuity plan in place to ensure that the needs of patients are met during and after a non-medical emergency (e.g. a power cut). You may wish to refer to NHS Connecting for Health’s example business continuity plan.
4. Appropriate policies for training reception and other practice staff in respect of dealing with emergencies and seriously ill patients, including resuscitation and anaphylaxis training and procedures.

Summary

Patients should be encouraged and supported to have sufficient food and drink that is nutritional and balanced, and a choice of food and drink to meet their different needs.

Complying with this outcome

The CQC don’t expect this standard to apply to GPs and other primary medical services because they don't provide food and drink to patients as part of their service.

If this standard doesn't apply to you, when you fill in your registration application you should declare that you are compliant with this standard.

The 16  core Essential Outcomes are:

• Outcome 1: Respecting and involving patients
• Outcome 2: Consent to care and treatment
• Outcome 4: Care and welfare of patients
• Outcome 5: Meeting nutritional needs
• Outcome 6: Cooperating with other providers
• Outcome 7: Safeguarding users from abuse
• Outcome 8: Cleanliness and infection control
• Outcome 9: Management of medicines
• Outcome 10: Safety and suitability of premises
• Outcome 11: Safety, availability and suitability of equipment
• Outcome 12: Requirements relating to workers
• Outcome 13: Staffing
• Outcome 14: Supporting workers
• Outcome 16: Assessing and monitoring the quality of service provision
• Outcome 17: Complaints
• Outcome 21: Records

The other 12 outcomes relate more to the routine day-to-day management of a service. They are:

• Outcome 3: Fees
• Outcome 15: Statement of purpose
• Outcome 18: Notification of death of a person who uses services
• Outcome 19: Notification of death or unauthorised absence of a person who is detained or liable to be detained under the Mental Health Act
• Outcome 20: Notification of other incidents
• Outcome 22: Requirements where the service provider is an individual or partnership
• Outcome 23: Requirement where the service provider is a body other than a partnership
• Outcome 24: Requirements relating to registered managers
• Outcome 25: Registered person: training
• Outcome 26: Financial position
• Outcome 27: Notifications – notice of absence
• Outcome 28: Notifications – notice of changes

Whilst these standards are being referred to as "non-core", do remember that compliance with these standards is a legal requirement

(To print a Quick Guide to the 28 outcomes  click on the icon)

Save

Summary

This outcome is about ensuring that there is a delivery of safe and coordinated care when patients move between providers or receive care from more than one provider.

Outcome in plain English

6A Transfer between services

• There should be a main person responsible for overall coordination
• The patient should have the name and contact details of the lead
• The treatment plan should include details of transfer arrangements
• There must be an accountable person/agency for each of the needs

People involved in the care of the person should:

• Co-operate
• Have documented plans
• Have relevant medical and other notes
• Each person must properly record treatment provided
• Have all information readily available

6B Information passed to another provider

• Include all relevant information about the patient to treat the patient safely. The prompt lists items as a minimum requirement for information to be provided.
• Make sure information is transferred in a timely manner
• There should be no interruptions to continuity of care

6C Organise yourself so that:

• One service provider has the lead coordinating role
• The other providers should know who this is
• All the providers should be involved and kept up to date in the treatment planning
• Discuss the plan with the patient

6D Major incidents and emergencies

• There should be a coordinated plan for major incidents and emergencies between the providers
• Be prepared for civil emergencies
• Monitor and review these plans as a coordinated provider group

6E Transfer of information

• Maintain patient confidentiality
• Information transfer is secure
• Agree in advance all information transfer protocols between providers
• Staff are aware of these protocols

Information transferred should be:

• Relevant
• Factual and correct
• Is allowed to be shared by Data Protection Act 1998 and other guidance.
• Staff notify the manager if there has been an information security breach

You must have procedures to deal with information security breaches, and these procedures should include

• Informing the patient of the breach
• Get patient permission if the information needs to be disclosed for public interest
• If patient consent is unobtainable; have clear reasons for your disclosure.
• Respect patient rights

6F The patient knows who to contact if their needs are not being met

6G The patient or the carer/guardian should know what information about them is being transferred and should be given a copy if requested

6H Transfer of information to another service

• Relevant information must be transferred to another service, unless there is a good reason not to.
• There reasons must be explained to the patient

6I Informing the patient of services available

• Tell the patient of health and social care services available to them
• Help them to make referral decisions
• Enable access to these services as long as their care is not compromised

6M Children moving on to adult services

• All providers should cooperate to ensure continuity and appropriateness of services to the age of the patient
• Children and their guardians are involved and kept informed

What the BMA says

Your practice is likely to be compliant if your practice does the following:  

1. Discusses with patients the options and arrangements for referral  
2. Includes in correspondence all of the information that would reasonably be required to treat the patient safely and effectively. For example:
3. the patient’s name, gender, date of birth, home address and NHS Number, where known;
4. if applicable, the name and contact details of the patient’s representative;
5. relevant information about the care and treatment provided to date;
6. relevant medical history, allergies, prescribed drugs and patient preferences;
7. infections that need to be managed (if relevant);
8. the reason for the referral and what is required;
9. By whom the referral is made and, where different, the person to contact in your practice about the patient and their contact details.
10. When a patient leaves your practice, transfers the relevant information to the new provider(s) in a timely manner so that the needs of patients can be met in an appropriate timescale
11. In the case of children and patients without the capacity to give consent, ensures that their parents/guardian/representatives are involved and informed about referral decisions.
12. When referring patients, ensures that patients know at least what type of information is being transferred.   
13. Respects the right of patients to request information about them to be transferred to another provider unless there is a good reason for not doing so.   

Your practice has the following:

1. An emergency preparedness plan including arrangements for sharing information and working with other providers. In the BMA/RCGP/DH’s pandemic flu guidance there are model arrangements for working with other providers during long term incidents e.g. a buddying-up system.
2. When cooperating with other providers/referring patients, arrangements that ensure that information is transferred and received safely and securely. To underpin this we suggest that you have a confidentiality protocol/information governance protocol that refers to information disclosures.
3. A protocol for acting on correspondence and results, to ensure that your staff are able to respond in a timely manner to incoming information.

Summary

Patients should be safeguarded from abuse, or the risk of abuse, and their human rights respected and upheld.

(Note: many of the prompts such as "Restraint procedures" are unlikley to apply to a GP setting)

Outcome in plain English

7A Minimise the risk and likelihood of abuse occurring by having a zero abuse tolerance policy

• Make sure staff know this and how to handle these situations
• Make sure staff are able to recognise signs of abuse
• That patients know how to raise concerns
• Recognise the signs and take preventative action where possible
• Have a feedback system and ability to do something about it
• Take action immediately
• You must have procedures to handle this
• Separate the abuser from the patient and others at risk
• Report abuse to authorities
• Make sure patient is looked after, after the above allegations
• If your system's not working, get it sorted

7B How you should organise yourself

• Work with everyone as a team
• Work with other agencies to learn who does what
• Must have proper procedures for restraint and safeguarding

7C Your staff should not be involved in the following:

• Don't have financial or personal dealings with patients as this compromises independence and ethics
• Don't do patient's wills
• Don't borrow stuff from patients
• Don't borrow money from patients
• Don't sell their stuff and keep the cash

7D Staff ethics

• Must be committed to patient rights and human rights
• Be aware of their responsibility in safeguarding patients

7E Staff training and awareness

• Staff must be trained and follow procedures in abuse situation
• Understand the impact in different cultures
• Understand the nature of abuse and the differences in support for children and adults
• Know what to do if there is a risk of abuse
• Follow the referral process and timescales required by regulations
• Understand roles of other organisations involved
• Active contribution to actions and improvement
• Collaborate with other services and help in investigative process
• Staff should be able to report any suspicions freely
• Follow any agreed plans to prevent further abuse

7F Restraint procedures

• Staff must understand different forms of restraint
• Understand appropriate usage of restraint
• Respect patient rights as far as possible
• Know permitted forms of restraints
• Restraint is the last resort

7G Understanding behaviours

• Understand how stimulating environment affects behaviour and how to communicate and prevent such effects
• Have prevention skills to help avoid incidents
• Share knowledge with other members of staff

7H Dealing with risk of adverse behaviour

• Carry out risk assessments on your techniques
• Restraint procedures must respect patient rights
• Get patient consent and document this arrangement where possible
• Document you plan on minimising restraint
• Use restraint as a last resort and minimise usage
• Keep records
• Follow relevant guidelines
• Carry out an assessment after restraint is used

7I Listening to patients

• Take patients and their people acting on their behalf seriously
• Provide appropriate help and support in reporting the abuse
• Keep everyone informed
• Make them aware of available support services
• Provide support as long as needed
• Assure them that care will not be compromised if they report abuse

7J Patients should have access to the following information:

• What abuse is and how to recognise the signs.
• What to do in suspected abuse cases and who to contact
• What will happen once the wheels are in motion

7K Patient rights

• Follow information confidentiality rules
• Be respectful of patient rights
• Make sure that staff exercising restraint are properly trained

What the BMA says

Your practice is likely to be compliant if your practice does the following:

1. Ensures that staff have had safeguarding training, if appropriate to their role, so that they can recognise the signs of possible abuse
2. Takes appropriate action to protect patients in the event that any member of staff exploits a vulnerable adult or child in any way.  Healthcare professionals at your practice should be reported to the GMC/Nursing Midwifery Council/HPC in cases where they are in possible breach of their professional guidelines. Performers should be reported to the relevant PCT.  
3. Ensures that patients can raise concerns and make complaints related to abuse. We suggest that you have a mechanism for patients to make comments and a publicised complaints procedure.
4. Shares relevant information with other providers, in accordance with local safeguarding procedures, when there are safeguarding concerns about a patient.   
5. Complies with the Vetting and Barring Scheme:  

• Practices that knowingly employ someone who is barred to work with children or vulnerable adults will be breaking the law.  
• Practices that dismiss or remove a member of staff/volunteer from working with children and/or vulnerable adults (in what is legally defined as regulated activity)
• Practices are under a legal duty to notify the ISA of relevant information, so that individuals who pose a threat to vulnerable groups can be identified and barred from working with these groups.

Your practice has the following:  

1. A safeguarding children (child protection) policy. You could base your practice procedures on the BMA’s Child Protection Toolkit or the RCGP’s Safeguarding Children and Young People Toolkit for general practice.
2. A safeguarding adults policy.
   
3. A patient information leaflet about abuse, containing information on what patients should do if they have suspicions that another person has been abused and what they might expect to happen under safeguarding procedures, is available in your practice.

Summary

Practices must provide care in a clean environment, and patients protected from acquiring infections.

Outcome in plain English

The CQC have not provided any guidance for this outcome.

The CQC advise that the Department of Health’s publication: The Code of Practice for health and adult social care on the prevention and control of infections and related guidance be followed in practice.

The table below sets out the 10 criteria of the 'Code of Practice’ against which a registered provider will be judged on how it complies with the requirement for cleanliness and infection control.

 For the full copy of the DoH Code of Practice and Guidance click here.
(Appendix D gives examples of interpretation for primary medical care providers)

What the BMA says

Your practice is likely to be compliant if your practice does the following:

1. Produces an annual statement, including a summary of: 
   •    any infection transmission incidents and any action taken (If necessary these incidents should be reported in accordance with your local incident reporting procedure);
   •    an infection control audit and actions taken;
   •    at least one Infection Protection & Control risk assessment;
   •    staff training;
   •    any review and update of policies, procedures and guidance
2. Furnishes premises having regard to national guidance and where possible and reasonable adapts rooms in accordance with risk assessments.
3. Publishes up-to-date information in your practice on your IPC programme, staff roles and responsibilities, and current infection issues.
4. Has a mechanism for patients to make comments/give feedback/raise concerns about your infection and prevention control and makes changes to practice as a result of this feedback if appropriate.
5. Provides advice and treatment to any patient that has an infection and assesses whether there are any communicable disease control issues, consulting local infection control experts or referring the patient for specialist treatment if necessary.
6. Ensures that everyone working in the practice understands the need to work to prevent and control infections in their daily work.  
7. Takes appropriate precautions when a patient is suspected or known to have a transmissible infection.
8. Ensures that staff have access to an occupational health service that is commissioned by the PCT and receive appropriate advice on immunisation (i.e. Hepatitis B) according to their role and duties from the service. We suggest that you document your staff’s immunity.

Your practice has the following:  

1. A designated infection prevention and control (IPC) lead, and a lead for ensuring appropriate cleaning of the practice environment and decontamination of practice equipment (they can be the same person).  
2. An infection prevention and control policy.
3. A decontamination policy.

Summary

Patients should have their medicines when they need them, and in a safe way. People are given information about their medicines.

Outcome in plain English

Follow this good practice to cover everything in this section

9A People who use services receive personalised care through the effective use of medicines

• Before administering medication take into account the patients:Ensures the person’s prescription for medicines is up to date and changed as per their needsMonitor the effect of the medicationEnsures the person’s prescription for medicines is up to date and changed as per their needsEnsures the person’s prescription for medicines is up to date and changed as per their needs
  • age
  • choices
  • lifestyle
  • cultural and religious beliefs
  • allergies and intolerances
  • existing medical conditions and prescriptions
  • adverse drug reactions
  • recommended prescribing regimes
    
• Ensures the person’s prescription for medicines is up to date and changed as per their needs
• Monitor the effect of the medication
• Advise them to take the correct dosage
• Have clear medicine management procedures
• Manage risk through having clear procedures about medicine handling

9B Treatment and support

• The provider should have clear procedures for
  • Storage,
  • Prescribing and/or
  • dispensing
  • disposal  which are reviewed and monitored
• These should include:
  • How medicines are handled and used
  • Staff training on medication handling
  • Covert  administration of medicines,  if needed
  • Take  a second opinion on medications for people detained under the Mental Health Act 1983
  • Record when a patient is not able self-administer their medications
  • Record when medications are given to a patient
  • Procedure for reporting adverse effects
  • Implement all medical safety alerts
  • Keep patients medication history
  • arrangements for medicines management following death of patient
• If controlled drugs are given at the practice then have procedure that:All procedure should comply with the requirements of the Medicines Act 1968 and the Misuse of Drugs Act 1971, and all other  associated regulations,
  • Investigate adverse effects, errors, etc.
  • Share concerns about mishandling of medicines
  • Reflect and learn from your findings

9C. Take into account all relevant legislation, regulations and best practice relevant to medicine management for your sector

9D  Promote rights and choices by providing people with information about medication:

• they are taking, including risks
• that may prevent ill health
• Ensure that staff have up to date information about medicines
• Have meetings with the patient and all parties concerned about their medication

9F Follow procedures for recommending home remedies

9G Patients receive support with their medicines

• Where required you should have these additional procedures:
  • Informing patients about clinical trial
  • Obtain information from the pharmaceuticals

9H medicines required for resuscitation or other medical emergencies are accessible

9J Patient safety alerts, rapid response reports and patient safety recommendations by the NPSA are actioned within required timescales

What the BMA says

Your practice is likely to be compliant if your practice does the following:  

Takes account of the following when prescribing medicines to patients:

• age;
• patient preference;
• lifestyle of the patient;
• the cultural and religious beliefs of the patient;
• allergies;
• existing medical conditions and prescriptions;
• history of adverse drug reactions;
• recommended prescribing regimes.

1. Observes the prescribing requirements of the contract governing the services it provides.
2. Stores all medicines on the premises appropriately and securely e.g. at the right temperature. 
3. Provides information to patients about the medicines that they are dispensing/prescribing including any risks such as side effects.  

Your practice has the following:  

1. A repeat prescribing policy that covers conducting medication reviews. However, your repeat prescribing policy should be specifically designed for your practice.  
2. A procedure for disseminating and acting on local/national clinical guidance, Medicines and Healthcare products Regulatory Agency (MHRA) alerts, national and local formularies and patient safety alerts to staff
3. Medicines handling procedures that cover the following that are appropriate for your practice: obtaining, storing, prescribing, dispensing, preparation, administration and disposing of medicines.
4. A controlled drugs standard operating procedure (SOP) at your practice. The Department of Health’s Safer Management of Controlled Drugs: Guidance on SOPs can be referred to for advice. This procedure should cover sharing concerns about mishandling and investigations of adverse events, incidents and errors.

Summary

Care should be provided on premises that are fit for purpose, and the environment be safe to deliver the services.

Outcome in plain English

10A Suitability of your premises

• Are they suitable to be a GP practice
• Carry out a risk assessment
• Comply with all legislation about premises
• Have all facilities needed in a GP practice e.g private consulting rooms;treatment areas
• Comply with all legislation about premises
• Provide disability access
• Don't have smelly premises
• Follow best practice on design and operation
• Must be safe for all patients
• Accommodate needs of a parent or carer of a child (mostly relevant to care homes)
• You have safety equipment and alarms and these are tested
• Suitable and comfortable surroundings
• Follow DOH guidelines

10B Other safety issues:

• Medical gas cylinders and pipe lines are properly installed and maintained
• Follow clinical waste guidelines
• Follow COSSH regulations
• Make sure alterations also comply with the above

10C Maintenance
Carry out a security risk audit
Ensure security of all users
Make sure personal property is protected

10D You must have procedures for the following:-

• Maintaining the premises and carrying out risk assessment
• Proper waste disposal
• If you make changes to the premises, then ensure that you follow all the principles above

10E Patients and staff understand What to do in the event of an emergency.

10F Facilities

• You must have enough toilets
• You must have infant feeding facilities
• Have alarm systems for mobility access patients
• Have an alarm system for staff needing urgent assistance
• Privacy for confidential briefings to patients and relatives

10G Plan and practise fire evacuation procedures.

10H You must have emergency procedures for:-

• Utility failures
• Fire & Flooding
• Other emergencies
• What you will do if the IT systems have also failed
• Décor must be maintained and refreshed

10I Mostly applicable to care home setting - space for therepeutic, educational activities and space for relatives to stay

10N You must have a disaster management plan for communications failure. How will patients access your services if all telephone and internet service don't work

What the BMA says

Your practice is likely to be compliant if your practice does the following:

1. Your practice is likely to be compliant if your practice does the following:  
2. As much as appropriate, has premises that reflect the Department of Health’s Health Technical Memoranda. These memoranda can be viewed if you register with http://www.spaceforhealth.nhs.uk Registration is free for NHS GPs;
3. As much as is reasonably practical, meets the requirements of the:

   •    Health and Safety at Work etc Act 1974;
   •    Management of Health and Safety at work regulations 1999; (Amendment 2006)
   •    Control of Substances Hazardous to Health Regulations 2002;
   •    Regulatory Reform (Fire Safety) Order 2005;  
   •    and any related health and safety legislation.  

   To do so we advise you follow the Health and Safety Executive’s (HSE) Introduction to Health and Safety guidance and use the template policy.
   As part of your compliance with this legislation you should conduct a health and safety risk assessment. We suggest using the HSE’s Five steps to risk assessment guidance and template.

4. When an issue cannot be resolved, seeks to manage those risks. For example, if you are unable to secure funding to make reasonable improvements to your premises to meet the above requirements from the PCT that controls premises funding then we suggest you consider managing that risk by displaying appropriate information (e.g. alternative practices, how to access support), providing appropriate support to patients or adjusting how you use different parts of your premises.
5. Takes into account of the needs of patients by having a mechanism for patients to make comments about your premises and acting on appropriate suggestions.
6. For the benefit of staff and patients:
   

   •    has appropriate arrangements in place for the collection, classification, segregation, storage, handling, treatment and disposal of healthcare waste;

   •    ensures that medical gas cylinders and pipe lines are installed, maintained and serviced in accordance with the manufacturer’s instructions and any safety alerts related to them;

   •    has a maintenance procedure, a person responsible for organising premises maintenance in response to risks that arise and a maintenance record.

7. Ensures that any electrical, heating, safety and building facilities comply with statutory requirements and the manufacturer’s instructions.

Your practice has the following:

1. Premises that meet your contractual requirements. In the case of GMS practices, your premises should meet, subject to any outstanding arrangements under the Schedule 6 (or equivalent) of the GMS contract,  the minimum requirements of the Premises Costs (England) Directions 2004 that can be viewed in Appendix 1 of the BMA’s Future of GP practice premises guidance;
2. A business continuity plan in place to ensure that the needs of patients are met during and after a non-medical emergency (e.g. a power cut). NHS Connecting for Health have produced a business continuity plan that you could use.  
3. Premises that are reasonably accessible to all patients and where reasonably practicable meet the requirements of the Equality Act 2010 regarding disabled people. Under the Act there is a duty to make reasonable adjustments to your premises for disabled people to be able to use your services. The Equality and Human Rights Commission’s starter kit provides further information on the Act.
4. Clear information about your fire evacuation procedures and other similar emergencies for patients on display.  
5. Information for staff about what to do in an emergency in your induction/staff handbook/induction pack.
6. Toilet and breast feeding facilities, including facilities for disabled people, if feasible and appropriate in your practice premises.

Summary

Where equipment is used, it is safe, available, comfortable and suitable for people’s needs.

Outcome in plain English

Follow this good practice to cover everything in this section

11A Adequate Equipment:-
Ensure the following

• You have a sufficient supply of equipment
• It is  safe
• It is suitable
• It is correctly installed, properly maintained and stored safely

11B Using the equipment on patients

• Consult the patient about what equipment and how it will be used
• Explain why you are using it
• Ensure their safety during use
• Ensure their privacy and dignity during us

11C Procedures you need to have

• Carry out patient safety risk assessments on equipment being used and address these risks
• Staff must know what to do if patient refuses to allow equipment to be used
• Have adverse event reporting systems in place
• If equipment used by patient themselves, train patients properly
• Consult patients representatives to ensure best interest
• Account for emergencies such as power, gas, water supply failures

11D Medical devices

• Make sure guidance on usage is in place
• Make sure you follow manufacturers professional body alerts

11E Follow all guidance and best practice

11F Safety and usage of medical devices

• Don't reuse single use devices
• Don't modify devices except in accordance with manufacturers instructions
• Make sure the devices pass legal requirements
• Devices are available when required
• Instructions for usage is enclosed by manufacturer
• Device is permanently installed where required
• Only used by staff who know how to use it
• Check it is working as it should when you are using it
• Maintained properly
• Kept in good repair by competent persons
• Properly disposed of

11G If device used by patient in their home, deal promptly with any safety issues you become aware of

11H Resuscitation equipment is readily available and is tamper proof

What the BMA says

Your practice is likely to be compliant if your practice does the following:

1. Ensures it has sufficient equipment for carrying out regulated activities that:

   •    is safe and suitable to use. We suggest that you have a system in place to ensure regular and appropriate inspection, calibration, maintenance and replacement of equipment including a named maintenance lead, a maintenance record, pre-planned schedules and a procedure for reporting faults; [You may wish to refer to the Health and Safety Executive’s Maintaining portable electrical equipment in offices and other low risk environments guidance.]

   •    is installed, used, cleaned/decontaminated and maintained in accordance with the manufacturer’s instructions, legislation and guidance from expert bodies;
   •    is stored safely and securely to reduce risks and prevent theft.

2. Addresses any concerns about the safety of equipment being used in a timely manner.
3. Conducts risk assessments of equipment and acts appropriately when risks are identified
4. Ensures that all staff using equipment have had adequate training and know what to do if a patient refuses to allow the use of equipment

Your practice has the following:

1. A business continuity plan such as that produced by NHS Connecting for Health.
2. Equipment required for medical emergencies available and accessible on the premises, and in tamper proof packaging.
3. A procedure for the dissemination of and acting on medical device alerts and national guidance as appropriate to the primary care setting and regulated activities provided

Summary

This outcome is about suitability of staff. Staff must be fit for the job and have the right qualifications, skills and experience.

Outcome in plain English

12A Recruitment process
Your recruitment process should cover the following:-

• Employ honest, reliable and trustworthy people
• Don't discriminate against applicants
• Check they are registered with the Independent Safeguarding Authority (ISA) if appropriate
• CRB check needed
• If working with adults, staff can work temporarily without a CRB check if an ISA check received BUT:-
  • Must have a designated supervisor
  • Supervisor must be there with them or available
  • Always need a full CRB checked person to escort patients away from premises
• If working with children they must have a CRB check
• Are they entitled to work in the UK
• Must have UK level standards of skills and qualification
• Using their professional title legitimately.
• Check this with their professional body.
• Follow codes of professional conduct
• Must be physically & mentally fit for job so that:
• They are not a risk to themselves
• They are not a risk to others
• Are able to communicate effectively
• Must have up to date job description  and understand it
• Aware of other team members' roles

12B Qualifications and skills

• Must have relevant skills knowledge & experience.
• If not, they must learn the skills, but make sure safety is not compromised
• Don't give students and trainees stuff that Is beyond them
• Need continuous education and training
• Teach them about diversity and human rights
• Able to communicate with patients
• Ability to listen and understand patients
• Know about and understands what patients need
• Know about our policies and procedures
• Know where to get expert advice
• Managers must be able to ensure staff are suitable

12C Effective recruitment procedure

• Must have processes that ensure all of the above.
• This also applies to agency workers; temps; etc. and you should make sure agency is also checking all this.
• Make sure that you have staff procedures to cover:
  • Staff absence
  • Discipline
  • Reporting to professional bodies
  • Abuse investigation
  • Harm/risk to patients
  • When your staff are barred from working with vulnerable adults
  • Staff needing special support
  • Staff exposed to physical/emotional risks
• Staff must follow all guidance

What the BMA says

Your practice is likely to be compliant if your practice does the following:

1. Recruits staff that have:

• the necessary skills, experience and evidence of relevant qualifications and training;
• demonstrated that they are legally entitled to work in the UK both from a professional and an employment viewpoint;
• provided proof of identity;
• given the name of two referees who can give references from previous recent employment;
• given reasons for their last position ending;
• provided their employment history, with a satisfactory written explanation of any gaps in employment;
• if appropriate to the role they will be carrying out, undergone a criminal record bureau check. The CQC’s Overview of Registration guidance provides further information about this in Chapter 6.

  We believe that much of this information can be gathered from a CV/application or at the interview stage.

 2. Recruits healthcare professionals that:

• are appropriately registered with their professional regulator (GMC/Nursing Midwifery Council/HPC) for the role they will carry out;
• are not subject to any form of suspension;
• have provided two referees willing to give clinical references relating to two recent posts as a healthcare professional which lasted for three months without a significant break (or where this is not possible, a full explanation and alternative referees).  
• are not on a Independent Safeguarding Authority barred list.

3. Unless contractual exemptions apply, ensures that the GPs it recruits are on a Performers List in EnglandConducts a fair and equal recruitment process that does not discriminate against any individuals.

4. We advise that you are observant of the Equality Act 2010 when recruiting staff (see the Equality and Human Rights Commission’s guidance) 

5. Follows NHSE’s guidance in only asking for information about candidates’ physical or mental health conditions after making a conditional offer.Ensures that staff review their skills and knowledge as part of appraisal or in house review. 

Your practice has the following:

1. A recruitment policy, including the need to comply with the Equality Act 2010
2. Procedures in place for when staff:

• are not well enough to work, including appropriate access to and use of occupational health support;
• behave outside of your policies or professional codes of conduct;
• are subject to investigations;
• are suspected to have caused harm or risk of harm to patients;
• require support to carry out their job.

Summary

This outcome is about having sufficient number of staff with the appropriate knowledge and skills to operate your service.

Outcome in plain English

13A Having sufficient staff
You have the right number and right staff for the job.

• You have enough knowledgeable staff cover for continuity.
• Prove that you have thought through staffing levels.
• Review and monitor your staff levels and requirements on a regular basis.
• Must have proper staff cover during absences, sickness etc.
• Must have staff cover if things are changing in the practice.

What the BMA says

Your practice is likely to be compliant if your practice does the following:

1. Is able adjust staffing to respond to unexpected circumstances such as sickness, vacancies and unpredictable short and long term events such as a flu pandemic.
2. Is able to change staffing in reaction to expected changes such as an expansion of the services provided or planned absence.
3. Ensures that staff are able to contact senior or supervisory staff.

Your practice has the following:

1. An appropriate number of staff with the appropriate knowledge, qualifications, skills, and experience to perform the services you provide to patients (and meet their needs) at the relevant times, including unexpected circumstances such as sickness and vacancies.
2. A staffing policy.
3. A recruitment policy.

Summary

This outcome is about the employer's duty to train the staff and make sure that they are monitored and supervised throughout. The objective is to ensure staff are competent to carry out their work and are properly trained, supervised and appraised.

Outcome in plain English

14A Staff support
You need the following:-

• An induction process
• Don't let staff work unsupervised without full induction
• Induction must cover:
  • Aims of practice
  • Patient rights
  • Your policies and procedures
  • What to do in an emergency
  • Health & Safety
  • Reporting incidents
  • How they will work
  • Lone Worker arrangements
  • Reporting quality problems
  • Job familiarisation
• Training needs analysis
• You need to provide continuous training and development for staff
• Make sure this is relevant and accredited
• Keep records of training

14B Dealing with children - Children should be dealt with by suitably trained staff

14C You must supervise your staff to ensure:

• Staff understand their responsibilities
• Make sure they are managed
• Follow national guidance & best practice so that:
  • Staff can approach managers for advice
  • Regular staff appraisals and meetings which are recorded
• You must have staff appraisals and development plans

14D – Staff support

• Help staff fit into their jobs where needed
• Everyone must follow professional codes of conduct
• Provide a safe working environment
• Procedures when staff subject to violence, bulling, harassment
• Support staff when they raise concerns
• Provide a safe working environment
• Procedure for work related illness

14F Staff must have regular "flying hours" or sufficient actual working knowledge of their job

14G Similarly, staff working with children must have relevant actual working knowledge

14H Children must have access to a registered nurse permitted to work with children

14 J All healthcare professionals should have an up to date professional registration/membership

What the BMA says

Your practice is likely to be compliant if your practice does the following:

1. Provides an induction for new staff.
2. Ensures that all staff are appraised on a yearly basis, including the identification of development objectives that reflect the needs of patients.
3. Ensures that staff are competent, trained and on the appropriate parts of their register to carry out their roles, and supports staff in taking appropriate training.
4. Ensures that staff have a readily available line manager or supervisor that they can talk to about any issues openly and honestly.
5. Makes reasonable adjustments to allow staff to perform their role when necessary and appropriate

Your practice has the following:

1. Procedures in place for when staff are subject to violence, bullying or harassment from patients or colleagues.

Summary

This outcome is really your formal public statement to the Care Quality Commission about what services are being provided.

Outcome in plain English

There are no prompts for this outcome.

Providers  are advised to follow the Legislation, Regulation 12 and Schedule 3 of the legislation.

Regulation 12
1. Statement of Purpose must be submitted to the CQC
2. It must be reviewed regularly
3. If there are any revisions, CQC must be informed within 28 days of such a change.

Schedule 3 Requirements:

• Aim and objectives of the service provision
• Types and range of services provided
• Name(s) of GP partners
• Name of registered manager
• Business Address
• Telephone number
• Email address
• Legal status of provider i.e. sole trader, partnership, organisation, etc.
• Details of the locations at which the services are  provided

Documents

For a copy of the CQC Statement of Purpose Template click here.

For a copy of the CQC Guidance on filling out the Statement form click here.

Summary

This outcome is about the management, monitoring systems, and decision making processes you have in place to ensure consistent and guaranteed quality assurance.

Outcome in plain English

16A Monitoring the quality of your services

• You must have proper quality monitoring systems.
• Examples of sources of your quality information:-
  • Patient feedback
  • Observations
  • Audits
  • Adverse events
  • Incidents
  • Errors and near misses
  • Investigations into the misconduct of a person employed
  • Comments and complaints
  • Claims
  • Professional bodies
• You must submit data where required by law
• Utilise findings from clinical audits both internal and by external bodies
• Identify non-compliance and risks of non-compliance and put it right
• Reduce risks of non-compliance

16B Ensure safe care by:

• Gathering information about risk to patients' safety
• Make changes to their plan of care if necessary
• Continuously identify risks, incidents, and errors
• Analyse adverse events
• Allow staff to raise concerns without being penalised
• Involve patients and staff in decisions"
• Practice informed consent about safety and self-responsibility

16C Reporting on risks to quality and improvement plans

• You should make your findings above available to patients and plan quality improvements

16D Decision making arrangements

• Involve the patient in decisions about their care with written descriptions of :-
  • Names and roles of decision makers
  • People who must be consulted
  • Types of decisions requiring consultation
  • What happens people are not available for consultation
  • Record how each decision was reached

16E You must have the following in place:-

• Continuous quality improvement
• Up to date description of your quality management system
• CQC can ask for a full description of your system

What the BMA says

Your practice is likely to be compliant if your practice does the following:

Collects and reviews information about its services for the purpose of quality improvement through:

• having a mechanism for patient feedback/comments;
• having a publicised and robust complaints procedure for handling complaints from patients, which complies with the Local Authority Social Services and National Health Service Complaints (England) Regulations 2009;
• conducting clinical audits (such as those required for the Quality and Outcomes Framework- see the BMA/NHSE QOF guidance). The RCGP has extensive guidance on conducting clinical audits.
• conducting regular significant event reviews and analyses. The National Patient Safety Agency has guidance on conducting significant event audits and analyses. There is also guidance on significant event reviews in the BMA/NHSE QOF guidance.
• conducting risk assessments as and when appropriate.

• collecting information related to misconduct investigations of its staff.

• Creates an environment where staff feel able, on a confidential basis if necessary, to raise concerns about risks to patients or staff.

• Circulates and acts on clinical guidance, medical alerts and safety alerts and any other relevant local or national reports so that staff change their working practices, if necessary, for the benefit of patients

Summary

This outcome is about ensuring that comments and complaints are listened to and acted on effectively, without fear of discrimination for making the complaint.

Outcome in plain English

17A For the complainant should be sure that their Comments and complaints are listened to and dealt with you need to:

• have a complaints procedure; which is monitored and reviewed.
• Have a complaints manager"
• Have a readily available complaints procedure
• ensure that the details of the complaint and the desired outcome have been understood
• make sure that advice and advocacy support is available
• Explain the timescales for the complaints resolution
• Properly investigate the complaint
• Keep an audit trail
• deal with the complaint in a factual manner
• make sure the complaint is dealt with by a competent person
• Complaints are reviewed by someone not involved in the complaint
• Comments and complaints should be resolved satisfactorily unless:The complaints procedure should address dealing with persistent complainants fairly
  • it is not the providers responsibility to deal with it
  • the complaint is not valid
• encourage openness
• Maintain full complaints logs
• Use the complaints to identify non-compliance
• The patient should be given the contact details of the CQC to report concerns

17B Shared treatment

• A patient who is treated by more than one provider should have a comprehensive response to their complaint

17C Providers registered with the CQC

• The annual complaints report is to be submitted to the CQC

17D People using the services should benefit from your compliance with all relevant legislation and best practice

17E People using  services or their representatives are able to use the comments and complaints process because:

• they are treated respectfully
• they know how to obtain the complaints procedure
• their complaints are dealt with in time
• Complaints can be filed verbally, in writing and in sign language
• Staff should help patients, where needed, to file a complaint
• Complainants should not be discriminated against
• They should know the timescales of the investigation and resolution process
• They can ask adult social services to assist them in filing a complaint
• If their treatment is funded by the NHS then they can use the NHS complaints procedure

What the BMA says

Your practice is likely to be compliant if your practice does the following:

1. Ensures that complaints are investigated in a proportionate and sufficiently thorough manner, and by appropriate staff (preferably someone not involved in the events leading to the complaints).
2. Allows patients to make general comments / suggestions about how the practice’s service could be improved, as well as complaints.
3. Deals with all patients in a fair and equal way, regardless of whether they have made a complaint.
4. Advises patients of their right to refer a complaint to the Parliamentary and Health Service Ombudsman if they are dissatisfied with the outcome of your investigation.

Your practice has the following:

1. A complaints procedure that is publicised on the practice premises and complies with the Local Authority Social Services and National Health Service Complaints (England) Regulations 2009. An example of a complaints procedure can be viewed in Appendix B12.  
2. A person responsible for handling complaints.  
3. Full records of complaints, including a documented audit trail of the steps taken and the decisions reached on each investigation.

Summary

This is not an "outcome" for a GP Practice, but a requirement to report to the CQC, so that patients can be confident that the CQC is following up with action.

Outcome 18 and Outcome 19 are virtually identical, as far as GPs are concerned.

• "Outcome 18" relates to reporting normal deaths whilst under your care
• "Outcome 19" relates to deaths of persons detained under the Mental Health Act 1983

Outcome in plain English

(Note: 18A to 18D are exactly the same as Outcome 19A to 19D)

18A The registered manager must send notification about deaths to the CQC

18B Where this task is delegated, the written decision making process under Outcome 16 should show this

18C GPs have to send this directly to the CQC

18D Don't disclose the identity of the deceased to the CQC, instead, use an indentification coding system instead of the name of the patient

18E If the death relates to someone detained under the Mental Health Act 1983  Outcome 19 applies

18F - Does not apply to a GP practice

18G Inform the CQC of any deaths whilst under your care

18H This prompt lists out the requirements of what information should be included in the notifications to the CQC

Summary

This is not an "outcome" for a GP Practice, but a requirement to report to the CQC, so that patients can be confident that the CQC is following up with action.

Outcome 18 and Outcome 19 are virtually identical, as far as GPs are concerned.

• "Outcome 18" relates to reporting normal deaths whilst under your care
• "Outcome 19" relates to deaths of persons detained under the Mental Health Act 1983

Outcome in plain English

(Note: 19A to 19D are exactly the same as Outcome 18A to 18D)

19A The registered manager must send notification about deaths to the CQC

19B Where this task is delegated, the written decision making process under Outcome 16 should show this

19C GPs have to send this directly to the CQC

19D Don't disclose the identity of the deceased to the CQC, instead, use an indentification coding system instead of the name of the patient

19F If the death was not of a person detained under the Mental Health Act 1983, Outcome 18 applies

19G If a patient is still missing after midnight, you must notify the CQC

DEATHS
19H Lists out Information to be included in the notification
19H Additional information to be included in the notification

UNAUTHORISED ABSENCES
19J Information to be included in notification:-

• The relevant section of the ACT under which they were detained
• Reason for the detention
• The circumstances in which they came to be absent.

Summary

Important incidents and events that affect pateint health, welfare and safety are to be reported to CQC directly.

Outcome in plain English

20A You must report all incidents to the CQC without delay

20B if you delegate this to someone (e.g. Practice Manager) you must have a written description of your procedures

20C Trusts have to report to NPSA

20D GPs report to CQC
Patient and staff identity is to be kept confidential, so use a cryptic code instead of a name, which allows you to identify the person if asked.

20F What you must report:

• Incidents affecting a person, which are:-
  •  Injuries
  •  Someone sectioned under Mental Capacity Act
  •  Allegation of abuse
• Events in the service which could affect everyone:-
  • Incidents reported to the police
  • Events that stop or may stop the service from operating safely and properly.

20G This prompt lists out details you must report such as the identifier or code for the person, date of birth, gender etc.
Their ethnicity.

20H What events you have to report

• Serious injury
• Injury that might have led to serious injury or death (near miss)

20I This defines what constitutes serious injury
In essence, anything that leads to or likely to lead to permanent damage, or damage that does or can last for 28 days. Pain lasting more than 28 days constitutes a serious injury.
The prompt lists out types of injuries as examples.

Another important addition is that near misses must also be reported.

20J Applies only to hospitals and care homes

20K & 20L Inform the CQC if you apply to the court to have someone sanctioned or imprisoned, together with details of incident

20M Other failures you must report

• Insufficient staff to operate or damage to property that may affect ability service
• The failure of a utility for more than 24 hours.
• The failure of fire alarms, call systems or other safety-related equipment for more than 24 hours.
• Anything that affects safety
• Send everything to the NPSA (which no longer exists), not to CQC. NHS Commissioning Board Special Health Authority have now taken over this function.
• Allegation of abuse

20N You must also report any suspicion, concern, allegation of abuse.
This means abuse of your patient by anyone including a GP or a member of your own staff.

20O to 20Q simply list out what details you have to report.

20R Call the CQC directly if police are involved about anything affecting the health, safety or welfare of any person

Statutory Notification Forms:

For a copy of the various notification forms click here

Summary

This outcome is about ensuring that patient records are accurate, fit for purpose, held securely and remain confidential. The same applies to other records that are needed to protect their safety and wellbeing.

Outcome in plain English

Follow this good practice to cover everything in this section to Manage risk through effective procedures about records

21A Personal records of care, treatment and support should be properly managed by:

• Maintain clear procedures that are followed in practice, monitored and reviewed
• Create and maintain medical records for each person who uses the service
• Document verbal communications about care on patient records
• Maintain factual, clear and accurate records
• Securely store and transfer all records; both internally and externally
• Having secure information sharing protocols
• Appropriate care is planned based on the persons' history
• Having one record per patient
• All relevant care givers should update and maintain the patient record
• If the provider should close then all records should be maintained for the legally required period.
• Follow all regulations when dealing with requests for information

The following records are to be kept for:

21B Healthcare records should be kept or disposed of in accordance with the Data Protection Act 1998, and all other relevant standards

What the BMA says

Your practice is likely to be compliant if your practice does the following:

1. Updates patient records at the same time as the events they are recording or as soon as possible afterwards
2. Makes a note of important points from discussions with patients in their records
3. Observes the Good Practice Guidelines for general practice electronic records version 4.  
4. Follows the requirements of the Data Protection Act 1998 and Freedom of Information Act 2000 when a patient requests access to their records. The BMA has guidance on patients accessing health records.
5. Follows the Department of Health’s Records Management NHS Code of Practice (Part 2)

Your practice has the following:

1. A confidentiality protocol or an information governance protocol.

Summary

This outcome is about your management qualities and qualification to deliver the services. The tests include good character, fitness for the role, and necessary qualifications, skills and experience.

Outcome in plain English

22A As the provider, you must demonstrate the following:-

• You are honest, reliable and trustworthy
• You are competent
• Your organisation has physically and mentally fit people to do the job, and you help those members who  aren't.
• If you don't have a registered manager, then you have enough skilled people to run the organisation
• You have passed all the CRB and other checks
• You give your manager all the resources they need
• You have given full authority to your manager to do their job

22B The provider must be able to do the following:

• You must be able to plan your actions
• You have to put Patients first
• Safeguard your patients
• Repeats 12A about recruiting appropriate staff
• You must do what you said in your statement of purpose
• Recognise weaknesses in skills and fix it

22C Legal responsibilities

• You must inform the CQC if any of the following happen to you:-
• Any convictions, cautions and warnings you get
• Any professional/regulatory actions against you
• Voluntary arrangements, bankruptcy etc.
• You must understand the CQC registration requirements
• You must comply with all laws and regulations
• Give the CQC information when they request it
• Co-operate in all investigations

Summary

This outcome is broadly simlar to outcome 23 in terms of fitness to run the service, but focused on arrangements required where the provider is NOT a partnership.

Outcome in plain English

Follow this good practice to cover everything in this section

If the service provider is a body other than a partnership they must manage quality by notifying an appropriate nominated individual
23 The nominated individual who is incharge of service management:

• Must be registered with the CQC
• Be of good character
• Is physically and mentally able to do the job

This means:

• The nominated person does not suffer from an illness which may cause risk to patients
• They themselves are not at risk because of a patients’ illness
• The nominated person must have the skills and qualifications for the job
• This includes that they:Undertakes continued professional development
  • have undergone all necessary employment checks before their appointment
  • are registered with the  Independent Safeguarding Authority (ISA)
• Has an awareness and knowledge of diversity and human rights
• Is aware of the services’ policies, procedures, legislation and standards
• Knows who to contact when advice is needed
• Is able to give the registered manager all the resources and information that they need
• Has given full authority to the registered manager to carry out their day to day job

Summary

This outcome concerns the role and responsibilities of the Registered Manager together with their fitness for the job, and the necessary qualifications, skills and experience.

Outcome in plain English

Follow this good practice to cover everything in this section

Employing appropriate managers
24A A manager should be able to demonstrate that they are:
1. of good character
2. physically and mentally able to do the job
    This means
    • The nominated person does not suffer from an illness which may cause risk to patients
    • They are not at risk because of a patients’ illness

3. Have the relevant skills and qualifications for the job
    As a minimum they should have:
    • effective communication skills
    • basic management skills

4. Undergone all necessary employment checks before taking on the role
5. Are registered with the Independent Safeguarding Authority (ISA)
6. Demonstrate registration with relevant professional regulators
7. Have the qualifications and competencies recognised by the relevant sector body
8. Know all relevant compliance requirements
9. The manager should be able to manage Resources
10. Understands how to delegate
11. Understands their staffs’ competencies
12. has appropriate job descriptions for their staff
13. is a good manager
14. ensure that people are safeguarded from abuse
15. Has an awareness and knowledge of diversity issues and human rights
16. Understands patient choice
17. Put into practice the statement of purpose.
18. Able to identify the learning and development needs of staff and make adjustments
19. Uses resources effectively
20. You need to inform the CQC of any convictions, warnings etc. that the manager has received or  if they are disciplined by their professional body

Summary

This outcome requires that the Registered Manager must be competent and must undertake appropriate training to carry out their responsibilities.

Outcome in plain English

25A The registered person must have proper training so that they have the relevant skills for the job. They should have

• Up to date knowledge and must comply with requirements of their service
• An understanding of the staffing and premises requirements
• A good organisational structure
• A good processes and management system
• Use the system to reduce risks and review on a regular basis
• Understand policies, processes and all standards

25B Effective management

The registered person must have proper planning to keep skills up to date so that they:

• Provide appropriate care
• Maintain patient involvement and rights
• Meet patient needs and follow legislation
• Meet the standards of the statement of purpose

Summary

Practices must ensure that they have the financial resources needed to provide safe and appropriate services.

Outcome in plain English

Follow this good practice to cover everything in this section

26A People who use services are confident that the provider has:

• The financial resources to provide continued care
• Insurance  cover and suitable indemnity arrangements are in place

Summary

This outcome is about the issue of cover when the Registerd Manager takes a leave of absence and ensuring that the service will continue to be properly managed during that period.

Outcome in plain English

You will need to notify the Care Quality Commission when the registered manager is away together with details of the arrangements in place to cover the period of absence.

27A - Planned absences

• 28 day notice must be given to the CQC if the registered manager is going to be absent for 28 days or more
• If 28 days notice is not possible, inform the CQC as soon as possible

27B - Emergency Absence

• If an emergency absence is likely to be 28+ days, inform the CQC within 5 days of the start of absence

27C - Notices of Absence

• Inform the Care Quality Commission of:
• the reason for the absence
• how long it will last
• who will run the service
• the name, address and qualifications of the person responsible
• If the length of the absence is unknown, propose to the CQC how long  before a new Registered manager is appointed

27D - Returning from an absence

• Inform CQC within 5 days of return

Summary

This outcome is about notifying the CQC about any changes to the Registered Manager position or other circumstances that are relevant to the CQC registration.

Outcome in plain English

You need to give the CQC formal notifications of the following:

28A Notifications relating to a registered manager

• If a person other than the registered manager is going to manage the service you need to notify the CQC of the following:
• Inform the CQC before the person starts
• If you have not been able to Inform the CQC before the start, then inform them as soon as possible

28B Changes to a Registered Manager's details

If the registered manager is an Individual you need to inform the CQC of the following:

• Changes to their name
• The appointment date
• The name of the New registered manager
• The date they will begin work

If the registered manager is a Partnership or an Organisation inform the CQC of any changes to the:
name

• business address
• officers (such as to the directors or secretary)
• Nominated individual
• The requirement to notify changes to officers does not apply to English NHS trusts

28C Changes to Financial Solvency:
If the provider is an individual:
Inform the CQC when they have been made bankrupt or their estate has been sequestrated

Where the provider is an organisation or limited liability partnership:
Inform the CQC when an administrator, receiver, liquidator or provisional liquidator has been appointed.