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12  •  Professionalism, Law and Ethics
317
cards and investigation results. Consent forms, copies of treatment plans and cost estimates should also be retained with patients’ records. If patients are receiving treatment under NHS regulations, NHS documentation should also be retained. Appointment books and day sheets may be useful should any query arise concerning the timing and extent of a particular patient’s treatment; consequently, their reten­tion can be extremely helpful. Telephone messages and any other memoranda concerning patients should be stored with their records. Finally, all records should be stored in a safe and secure place where they are easily retrievable when next required. Paper records must be kept in a locked container (e.g. a filing cabinet); electronic records must be protected using appropriate electronic security measures. Access to data must be restricted to personnel who have a legitimate reason for that access.
When records are eventually disposed of, they must be
destroyed under confidential conditions.
Data Protection
Failure to comply with data protection has been a criminal offence since the Data Protection Act (1998). The holding and processing of personal data was made more stringent by the General Data Protection Regulation (GDPR) that was approved by the Parliament in 2017 and came into effect in May 2018. Personal data is any information relating to an identified or identifiable person and includes:
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names
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addresses and telephone numbers
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dates of birth
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name of general medical practitioner
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hospital record numbers.
There are also special (sensitive) categories of personal
data, such as:
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health details
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ethnicity
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sexual orientation
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religion
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political views.
With the exception of non-profit making organisations, all organisations have to register with the Information Commissioners Office (ICO). All (including non-profit mak­ing organisations) have to appoint a Data Controller who will probably be the head of the organisation and a Data Protection Officer (DPO) who is responsible for the control of all data processing activity; one person can undertake both of these roles in small organisations. The DPO has to decide who in the organisation can process or have access to personal data (a data processor). All data processors have to formally agree to abide by their legal obligations under GDPR in their contracts of employment, or their indepen­dent involvement in the organisation if they are self­employed. To ensure compliance with these regulations, it is advisable that all staff are made aware of their obliga­tions under these regulations. The ICO must be given the contact details of the DPO.
All patients have to formally consent to the retention of their personal data by the organisation, be informed of the limitations governing the use of that data and given a Pri­vacy Notice informing them what the data will be used for.
The Privacy Notice should also be available on the premises and the organisation’s website; it should include:
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the Data Controller’s identity
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the Data Protection Officer’s contact details
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the purpose of the data processing
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the legal basis for data processing
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categories of personal data processed
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potential recipients of personal data
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details of retention periods of data
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a list of data subjects rights, including the right to com­plain to the ICO if they have any concerns about the handling of their data.
Retention of Records
Records should be retained in accordance with the current legislative requirements.
The UK Department of Health, via NHS Digital, publishes a Records Management Code of Practice for Health and Social Care. This was last updated in 2016. This document contains detailed retention schedules. Timescales for retention of re­cords are dependent on a number of criteria – full details of this Code of Practice and detailed retention schedules are available on the NHS Digital website (https://digital.nhs.uk).
It cannot be overstated that records should be:
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accurate
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complete
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comprehensive
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contemporaneous
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legible
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retrievable
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retained in accordance with the current legislative requirements.
Medical History
It should never be forgotten that medical history is an es­sential part of dental or medical records. Medical history should always be taken at the initial visit of a patient and rechecked and updated at every subsequent appointment.
Confidentiality and Disclosure
All health care records are confidential between the patient and those involved in their care and should not be disclosed to a third party without the patient’s permission. There are occasionally circumstances when a Court Order may be produced which would compel disclosure. As the rules gov­erning disclosure vary according to the circumstances, the advice of the dentist’s defence/protection organisation should be sought on this matter. It is essential that all staff employed by a dentist are aware of patient confidentiality and do not break any confidences. Any breach of confiden­tiality by a member of staff is the responsibility of the den­tist both legally as an employer and ethically as a member of a caring profession.

CONSENT AND RELATED MATTERS

No treatment can be carried out on a patient without that patient’s or their legal guardian’s valid informed consent for that specific treatment to be undertaken. Undertaking treatment without consent is an assault on the patient. Consent can be implied, verbal or written.
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Master Dentistry
Implied Consent
Examples of implied consent:
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If a patient has previously been presented with a treat­ment plan and arranges further appointments for this treatment plan to be carried out, implied consent can be assumed.
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If a patient requests local anaesthetic for fillings and opens his/her mouth to allow local anaesthetic to be administered.
Verbal Consent
For example, a dentist may say:
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‘Would you like a local anaesthetic for me to put the filling in your tooth?’
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‘I am going to give you local anaesthetic for this filling/ extraction’.
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‘I think that the most urgent treatment you need is a filling in this tooth’.
The patient either verbally agreeing to the above or open­ing his/her mouth to allow the dentist to proceed would be valid consent, providing the dentist is confident that the patient understands what is going to happen. If there is any doubt regarding the patient’s capacity to understand the treatment fully, no treatment should be undertaken.
Implied or verbal consent is frequently sufficient for treat­ment without any form of anaesthetic or when treatment is undertaken with local analgesia, as the patient can request that the treatment is stopped at any time, and they may wish to withdraw consent.
Written Consent
Written consent must be obtained if the patient is having treatment under sedation or general anaesthesia when they are not fully conscious of the treatment being carried out and are, therefore, in no position to ask for the treat­ment to be stopped should they wish to withdraw consent. Written consent is also advisable for any complicated and/ or expensive treatment even when this is carried out with­out any form of anaesthetic or with local analgesia.
Written consent is advisable when carrying out a proce­dure that carries one or more specific risks. For example, prior to the removal of an impacted lower wisdom tooth, a patient should be warned of the possibility of swelling, tris­mus and the risk of trauma to the inferior dental nerve, which would lead to labial anaesthesia/paraesthesia, or trauma to the lingual nerve, which would cause similar problems with the tongue. The use of the mnemonic STALL (swelling, trismus, anaesthesia of lingual or labial nerves) may ensure that appropriate warnings are given. These warnings should be entered in the patient’s record. It is es­sential that written consent should contain details of the procedure, the type of anaesthetic or analgesic that will be used and any complications that may occur during treat­ment. Without being patronising, consent should be worded in a language that the particular patient understands, avoiding the use of jargon and abbreviations to describe a particular clinical procedure.
As part of the consent procedure, the clinician should advise the patient of all treatment options, as well as any
risks of not having the suggested treatment. Also, if ap­propriate, the patient should be informed of the current national guidelines relating to the treatment of the condi­tion. When discussing risks, it is essential to have knowl­edge of the patient’s circumstances; for instance, the likelihood of nerve damage resulting from the removal of impacted wisdom teeth will need to be quantified as it could affect the livelihood of, for instance, a lecturer, singer or musician.
For treatment carried out under sedation of general anaesthesia, it is advisable to undertake the consent pro­cess at an initial consultation, and to confirm the consent when the patient attends for the actual treatment. Partic­ularly under these circumstances, except in an emergency, consenting just as treatment is about to commence is not advisable.
Additionally, after the patient has been made aware of all choices including alternatives and any risks, this does not diminish the duty of care that the operator has to act carefully and skilfully when carrying out a procedure, as obtaining consent is no defence for inadequate treatment or a poor technique.
Because of the nature of dentistry in the United King­dom at the present time, it is essential that the patient is aware of whether they are consenting to treatment un­der the NHS or by private contract before treatment commences.
Special Cases
Age of the Patient
The minimum age for valid consent is considered to be 16 years; however, if a practitioner is satisfied that someone of less than 16 years of age fully understands the treatment to which they are consenting, their consent may be valid. Particularly in the case of sedation or general anaesthesia, the consent of a parent or guardian or someone over 18 years should be obtained as well as from the patient themselves for those between 16 and 18 years of age.
Adults Lacking Capacity
These patients may be unable to give informed consent, it is recommended you review local legislation that will gov­ern these circumstances. In the UK, this is covered by the Mental Capacity Act.
According to the Mental Capacity Act of 2005, a person is unable to make their own decision if they cannot do one or more of the following four things:
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understand information given to them
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retain that information long enough to be able to make the decision
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weigh up the information available to make the decision
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communicate their decision – this could be by talking, using sign language or even simple muscle movements such as blinking an eye or squeezing a hand.
For any major treatment, it is normal practice for the agreement of two practitioners of consultant status to be obtained prior to treatment. Alternatively, as a result of the 2019 Amendment to the Mental Capacity Act, a trained Independent Mental Capacity Advocate (IMCA) can be appointed to look after the patient’s best interests.
12  •  Professionalism, Law and Ethics
319
Patients With Specific Ethnic Customs or Beliefs
Practitioners should always be sympathetic to specific patient beliefs and requests (e.g. the avoidance of blood transfusions to Jehovah’s Witnesses, the avoidance of materials derived from any animals for vegetari­ans and from certain animals for religious or cultural reasons). It should also be remembered that certain cul­tures object to women receiving treatment from male practitioners.
Life-Saving Procedures
Occasionally, it may be necessary to carry out a life-saving procedure on an unconscious person. Under these circum­stances, informed consent is normally unobtainable, but any treatment under these circumstances should be limited to that which is life-saving. Non-life-saving treatment should be delayed until consent is obtained.

CHAPERONES

It is always advisable to have a chaperone present for all patient contact even if active treatment is not involved. The presence of a third person can be useful in confirming con­sent and may be required to avoid any allegation of impro­priety. When carrying out treatment, the dentist should normally be assisted by a dental nurse, who can also act as a chaperone. It should be remembered that whether attend­ing a patient in the dental surgery or on a domiciliary visit, another member of the dental team or another person should be present at all times. It would be considered good practice to take into account who would be appropriate as a chaperone in individual situations; this may, for example, include gender or cultural considerations.

12.6 General Anaesthesia and Sedation

LEARNING OBJECTIVES
You should:
• know who can administer general anaesthesia and
sedation to your patients
• understand the role of the dental operator under these
circumstances.
When patients are receiving treatment under general an­aesthesia or sedation, it is essential that written informed consent is obtained prior to the procedure being under­taken. Whenever possible, this consent should be obtained at a consultation and treatment planning appointment, as signing the consent form when the patient arrives for this treatment and immediately before the anaesthetic and se­dation is administered could be considered as signing under duress.
Any patient who is to receive treatment under general anaesthesia or sedation must be accompanied by a friend or relative who can take responsibility for the patient’s care following treatment. The presence of this accompanying person, and confirmation of their availability for the time required for the patient to recover sufficiently to not need
support, must be established prior to administering any general anaesthesia or sedation.
Prior to November 1998, dental surgeons who had re­ceived the appropriate training were allowed to administer general anaesthesia to patients. The ethical guidance on general anaesthesia from the GDC clarified the roles and responsibilities of those involved in carrying out dental treatment under general anaesthesia, and it specifically precludes dentists from administering general anaesthesia.

GENERAL ANAESTHESIA

The Referring Dentist
Any dental surgeon who refers a patient for treatment under general anaesthesia must:
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take a full medical history
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explain to the patient the risks involved
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offer alternative methods of pain control
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obtain consent.
When sending a patient for treatment under general anaesthesia, the dentist’s referral letter should contain full justification for the use of general anaesthesia and proper records must be kept by the referring dentist.
The Dentist Treating a Patient Under General Anaesthesia
The dentist treating a patient under general anaesthesia must:
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repeat the history taking
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repeat the explanations concerning risk and the alterna­tive methods of treatment and pain control
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obtain the patient’s or the parent’s written consent
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give written pre- and postoperative instructions
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keep careful records.
Treatment Under General Anaesthesia
For treatment of a patient under general anaesthesia, it is essential that:
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the dentist/surgeon has an appropriately trained dental/ general nurse available for assistance
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the anaesthetic is administered by an anaesthetist on the GMC’s Specialist Register; if a trainee anaesthetist/ non-consultant career-grade anaesthetist gives the an­aesthetic, that doctor must be working under a named consultant anaesthetist
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the anaesthetist is supported by someone experienced in monitoring the patient’s condition and able to assist the anaesthetist in an emergency
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the anaesthetist and the dental surgeon have an agreed written protocol for the provision of advanced life sup­port, including agreed arrangements for the immediate transfer of a patient to a critical care facility
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recovery and discharge is the responsibility of the anaes­thetist, and recovery nurses must be properly trained and responsible to the anaesthetist
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all personnel involved in anaesthetics train together.
The GDC makes it clear that it is the responsibility of the treating dentist to ensure that these protocols for general anaesthesia are adhered to.
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SEDATION

Conscious sedation is defined as a technique in which the use of a drug or drugs depresses the central nervous sys­tem, thus enabling treatment to be carried out, but during which communication with the patient can be maintained. The modification of the patient’s state of mind should be such that the patient will respond to command throughout the period of sedation. Techniques used should carry a margin of safety wide enough to render unintended loss of consciousness unlikely.
A suitably experienced and trained dental surgeon can administer sedative drugs as well as operating on the pa­tient, providing at least one other appropriately trained person is present throughout the procedure. This other person must be capable of monitoring the clinical condi­tion of the patient and of assisting the dental surgeon in the event of an emergency. An appropriately trained dental or general nurse can fulfil this duty; ideally, this person should be present in addition to the dental nurse providing close support for the dental treatment.
The GDC recommends that normally a single drug should be used for intravenous sedation; if more than one sedative drug is utilised, the provision of advanced life support must be immediately available. Whatever sedation techniques are used, contemporary appropriate standards of patient monitoring should be adopted during conscious sedation. As intravenous sedation is unpredictable in children, it is recommended that this technique is used only under very special circumstances.
Before undertaking treatment under sedation, a dental surgeon must:
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carefully assess the patient, including a full medical and dental history
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explain the sedation technique proposed
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advise on appropriate alternative methods of pain and anxiety control
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provide clear and comprehensive pre- and postoperative instructions in writing
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obtain written informed consent for the sedation and treatment proposed
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ensure that proper equipment for the administration of the sedation technique is available
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ensure that the facilities are adequate
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adopt contemporary standards of monitoring the patient
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ensure that appropriate drugs for resuscitation of the patient are readily available
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ensure that the dentist and staff are trained in the seda­tion procedure being used and resuscitation techniques. It is essential that all those involved in the provision of sedation and/or the supervision of recovery of sedated patients should train together as a team to deal with any emergencies, and that this training should include fre­quent practice of resuscitation routines in a simulated emergency
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ensure that patients recovering from sedation will be appropriately supervised, protected and monitored in adequate recovery facilities.
Monitoring of patients should be undertaken either by the sedationist or by an appropriately trained person
responsible to the sedationist. When the sedationist consid­ers the patient is sufficiently recovered to leave the premises, they must be accompanied by a responsible adult. Where nitrous oxide/oxygen sedation alone has been used for an adult patient, a dental surgeon may exercise discretion as to whether that patient is fit enough to be discharged unaccompanied.

CHAPERONES

During treatment under general anaesthesia or sedation and in the recovery room following general anaesthesia or sedation, the presence of a third person is mandatory. It is advisable that either the dentist or another person present is of the same sex as the patient, or is a relative of the patient.

12.7 Complaints Procedure and Negligence

LEARNING OBJECTIVES
You should:
• understand how the health complaints procedure
works in the United Kingdom so that you are able to deal with any complaints expeditiously
• understand the meaning of negligence
• be aware of how best to avoid an accusation of
negligence.
All health care organisations must have a complaints pro­cedure; this applies to all branches of dentistry, including general dental practice. There has to be designated person/ persons in each health care organisation to accept com­plaints, acknowledge the receipt of all complaints and keep the complainant informed of how the complaint is pro­gressing. Complaints should be answered within a reasonable time of the complaint being made. Mediation between the parties, rather than confrontation, is encour­aged to allow the resolution of any grievance the patient may have. As part of the GDC’s information, standards and guidance, there are principles published for complaints handling best practice and a publication entitled Handling Feedback and Complaints in the Dental Practice. This is avail­able to download from the GDC website along with other useful resources.
Adaptation and flexibility are important when handling complaints, and whilst there is no one correct way to ap­proach their management, there are a number of key areas to consider. These include ensuring complaints are recog­nised, a thorough investigation ensuring all of the facts are gathered, establishing what is needed to resolve dissatisfac­tion and an appropriate response. It is also important to consider what learning that can be taken forward following complaints for future personal/practice development and risk management. This may include review of aspects which led to the complaint and processes and protocols which are currently in place.
Further advice, face-to-face training and web-based resources are available from a variety of organisations to gain further understanding of key areas of how you should
12  •  Professionalism, Law and Ethics
321
approach the management of a complaint. These include dental indemnity providers.

‘MIXING’

Mixing is the term used for providing some treatment under the NHS for a patient and other treatment for the same pa­tient privately. It is a situation fraught with difficulties and is best avoided if at all possible. It is advisable that any course of treatment be undertaken entirely under NHS regulations or entirely under a private contract. If this is not possible, it is important that:
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it is not implied to the patient that NHS treatment is inferior to private treatment
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the patient fully understands which items are being car­ried out under NHS regulations and which privately and consents to this, preferably in writing
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the NHS-funded treatment is completed prior to under­taking items of treatment that will be charged privately.
When dealing with complaints, as previously men­tioned, every provider of health care is obliged to set up a system for dealing with complaints from patients. Since 2009, a complainant can complain directly to the primary care organisation responsible for the service or directly to the service provider. In secondary care, the complaint should be made to the hospital or other institution provid­ing the care. Each part of the United Kingdom (England, Scotland, Wales, Northern Ireland) has slightly different protocols for this, which can be found on the appropriate websites. For England, it is the Local Authority Social Services
and National Health Service Complaints [England] Regula­tions 2009.
Every effort should be made to deal with complaints as quickly as possible, as the longer a feeling of dissatisfac­tion or aggravation continues, the more entrenched the parties become, which makes the problem more difficult to solve.
In addition to a complaints procedure, organisations may wish to have processes in place to actively seek and encourage comments and suggestions from patients.
It is hoped that the vast majority of complaints will be dealt with locally. If a patient makes a complaint in person, the designated person should endeavour to discuss the na­ture of the problem at the time the complaint is made. Any discussion should take place in a private office to protect patient confidentiality and give an atmosphere conducive to resolution of the complaint. The term ‘Complaints Man­ager’ is probably best avoided, but the person designated to deal with complaints (the responsible person) should inform the complainant of their name and status in the practice or organisation.
Organisations have a responsibility to develop an effec­tive complaints procedure. These will vary dependent on local circumstances and must be compliant with their legal and contractual obligations. The contracting agree­ment will contain specific details of what the complaints process should contain and the timelines within which this should be actioned. Practitioners should ensure their patients are aware of the local complaints policy. Some complaints processes include scope for a local resolution meeting.
Parliamentary and Health Service Ombudsman
This body makes final decisions on complaints which have not been resolved by the NHS in England and UK govern­ment departments and other UK public organisations. Any patient still dissatisfied after the NHS complaints procedure has been completed may ask the Parliamentary and Health Service Ombudsman to investigate the case. This ombuds­man is completely independent of both the NHS and the government and can investigate complaints about NHS services and how the complaints procedure is working. The Ombudsman is not obliged to investigate every complaint and will not generally consider any case that has not first been through the NHS complaints procedure, nor any case that is being dealt with by the courts.
GDC Complaints Service
The 2005 Amendment Order to the Dentists Act of 1984 allowed the GDC to set up a complaints scheme for private patients. This is known as the Dental Complaints Service and was launched in 2006. This service is funded by the GDC. They will look into complaints raised with them within 12 months of the treatment happening or within 12 months of the patient becoming aware they have something to complain about. Again, patients are recommended to at­tempt local resolution in the first instance. If local resolu­tion is not successful, a complaints officer discusses the matter further with the patient and the practice to attempt resolution. This service has also set up complaints panels consisting of two lay people and one dental professional who have been given appropriate training. If the patient remains dissatisfied and the complaints officer is unable to resolve the complaint, the service will convene a complaints panel if it believes this is appropriate. The panel will listen to both parties, independently and impartially in a non­legalistic way. After the panel has considered the complaint, it is able to endorse any appropriate agreement reached between the dental professional and the patient, or if an agreement cannot be reached, recommend one or more of the following:
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That no further action should be taken.
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That the dental professional reviews their future practice.
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An apology to the patient.
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An offer of a refund of part or all of the fees.
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A contribution towards remedial treatment up to the amount of fees paid.
Further information is available on the dental complaints
service website (https://dcs.gdc-uk.org).

NEGLIGENCE

In the treatment of patients, the following may be considered negligent:
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Failure to exercise reasonable skill and care.
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Omitting to do something that a reasonable person would do, considering what normally regulates the conduct of human affairs.
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Doing something that a prudent reasonable person would not do.
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Master Dentistry
Every dentist is expected to exercise reasonable skill and care in every treatment she/he carries out by virtue of their dental qualification (i.e. a similar degree of skill and care as exercised by the majority of colleagues). A general practi­tioner would be compared with other general practitioners, and a specialist with other specialists in the same field. Also, no dentist should undertake treatment for which he/she is not trained and competent to undertake; consequently, failure to refer to a specialist when appropriate could be considered negligent.
A practitioner is expected to exercise reasonable skill and care whether a patient is being treated privately, under the NHS, as an act of friendship or even as a ‘good Samaritan act’ in an emergency.
To recover compensation for negligence, it is necessary to prove:
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that the practitioner owed a duty of care to the patient at the time
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that there was a breach of that duty
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that damage or suffering occurred as a result of the action of the practitioner.
This means that if the patient suffered no harm or dam­age as a result of the practitioner’s action, there is nothing for the patient to be compensated for, so no compensation will be paid.
A dentist cannot guarantee that all treatments provided will be uneventful or free from accident even if there is no lack of care and skill. To prove negligence, the patient (plaintiff) has to prove that harm has been caused as a re­sult of lack of care and/or lack of reasonable skill that the practitioner (defendant) had a duty to apply. Unless the plaintiff can satisfy the court of this, the claim will fail.
If a very obvious mistake or damage has occurred to a patient, the patient’s legal adviser will make a plea of res ipsa loquitur. This legal term basically means ‘the thing speaks for itself ’. Carrying out treatment on the wrong tooth or treating the wrong patient could be considered as examples.
Contributory Negligence
If something occurs or is made worse by an action or failure by the patient, the defendant can plea contributory negli­gence, which may reduce or negate any damages that are awarded. An example of this would be failure on the part of the patient to follow pre- or postoperative instructions or grabbing the dentist’s arm when he was using a sharp instrument or a dental handpiece.
Unsuitable Treatment
Dentists should always resist being talked into undertaking treatment by a patient that is unsuitable or of very poor prognosis (e.g. advanced restorative treatment on teeth with gross periodontal disease). Carrying out treatment that is very likely to fail or cause severe problems is as much negligent as any other professional act a dentist performs.
Vicarious Liability
As an employer, a dentist can be held responsible for any acts or omissions of his/her staff. This applies to all grades
of staff, whether or not that member of staff was or was not acting in accordance to instructions. At the same time, however, the employee is responsible for his/her own acts. Therefore, a claim for negligence could be brought against the employer, employee or (as is more commonly the case) against both. In the case of partnership agreements, each partner is individually and jointly liable for the actions of other partners. Therefore, it is essential that all partnership agreements include the provision to provide indemnity for the partnership as a whole.
The Bolam Principle Test
The Bolam principle has been used as the benchmark in the assessment of professional negligence. In 1957, Judge McNair in the High Court directed the jury in the case of Bolam v. Friern Hospital Management Committee that ‘a doc- tor is not guilty of negligence if he has acted in accordance with the practice accepted as proper by a reasonable body of medical men skilled in that particular art’. This means that, if there is more than one respectable body of profes­sional opinion concerning diagnosis or treatment, there is no negligence should a practitioner choose one protocol in preference to another.
The Bolam principle was re-examined in 1997 in an ap­peal to the House of Lords (Bolitho v. City and Hackney Health Authority). This particular case involved an omis­sion to carry out a procedure on a patient that several experts supported but others did not. Their Lordships opined that the use of the adjectives ‘responsible, reason­able or respectable’ concerning a body of opinion may not be sufficient, but that experts’ views should include scien­tific evidence on the comparative risks and benefits to de­cide whether or not an act or omission is defensible. With the advent of clinical governance and evidence-based medicine leading to clinical guidelines, the Bolitho judge­ment replaced the Bolam principle as the benchmark for negligence.
Where there is more than one accepted medical/dental opinion in a particular case, it is the clinician’s decision which is most appropriate. It is not a decision for the court to make, as there is seldom any one answer exclusive of all others to the problems of professional judgement. Even if a court prefers one body of opinion to another, that is no ba­sis for a conclusion of negligence (Maynard v. West Midland Regional Health Authority, 1984).
Further guidance arose following the case of Montgom- ery v. Lanarkshire Health Board (2015) in which the UK Supreme Court opined that as it was not recorded that the patient had not been informed of a risk that a reasonable patient may wish to take into account before deciding whether or not to proceed with a particular treatment op­tion, the clinician was negligent. This reinforced the deci­sion made by the High Court in 1985 (Sidaway v. Board of Governors of Bethlem Royal Hospital) concerning risks of treatment. The conclusions from these cases confirm that the patient must be informed of any material risks as well as the benefits of treatment, as it is the patient who will have to live with any complications that occur. The process of obtaining consent must be patient centred, rather than the former paternalistic approach of the clinician as the one who ‘Knows Best’.
Time Limits
Claims for negligence normally have to be made within one of the following time limits:
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Within 3 years of the plaintiff becoming aware of having suffered damage.
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Within 6 years of the incident occurring.
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Within 6 years of reaching the age of majority (18 years) in the case of alleged negligence occurring in a minor.
At the Court’s discretion, claims can be brought outside these limits if the plaintiff can persuade the Court that there is a good reason for ignoring them.
In 1999, two important legal changes have occurred affecting all claims for compensation, not just medical and dental claims: legal aid/contingency fees and the Woolf report.
Legal Aid/Contingency Fees
The government has introduced further limits to the pay­ment of legal aid so that fewer plaintiffs will be eligible to receive legal aid. By way of compensation for this restriction of legal aid, solicitors are now able to work on a contingency fee basis. Contingency fees, which have been accepted in the United States for many years, involve the lawyer only receiving a fee if the client’s claim is suc­cessful. It has the advantage that if the plaintiff/client does not have sufficient capital available to pay legal fees, these will not be charged should the case be unsuccessful. This gives an additional impetus to the lawyer to make certain of success. Disadvantages may include lawyers charging higher fees, which may be fixed or a percentage of the total compensation obtained, and a reluctance of lawyers to take on any cases except those with an almost certain chance of success. Even with this system, there may be some cost to the claimant, as solicitors may be unwilling to fund such fixed costs as specialist medical reports necessary to support a claim – unless, that is, they can find dental/medical experts who are also willing to work on a contingency fee basis.
The Woolf Report
In July 1996, Lord Woolf published his report to the Lord Chancellor on proposed reforms of the Civil Justice System for England and Wales. These recommendations came into effect on 26 April 1999 and affect the legal profession more than the dental and medical professions in that a very strict timetable is laid down for each stage of the procedure. These rules are detailed in the Civil Procedure Rules pub­lished in January 1999. The over-riding objective of these rules is to enable the courts to deal with cases justly. This includes the following:
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Ensuring that the parties are on an equal footing.
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Saving expense.
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Dealing with the case in ways that are proportionate to:
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the amount of money involved
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the importance of the case
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the complexity of the issues
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the financial position of each party.
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Ensuring that the case is dealt with expeditiously and fairly.
12  •  Professionalism, Law and Ethics
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Allotting to a case an appropriate share of the court’s
323
resources, while taking into account the need to allot resources to other cases.
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Requiring the parties involved to help the court in the furtherance of the above objectives.
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Restricting expert evidence to that which is reasonably required to resolve the proceedings; this means that, whenever possible, a single joint expert is appointed to act on behalf of the court, rather than the plaintiff/ claimant or the defendant. This can occur either by agreement with the parties involved or, if necessary, an expert can be appointed by the court.
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The plaintiff/patient will in future be called the claimant.
Claims will be divided into three types:
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Small claims track: this is for claims of compensation of up to or equal to £5,000 in most cases but is limited up to £1,000 in personal injury.
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Fast track: this is for claims of up to £15,000; compli­cated claims of under or equal to £15,000 may not be considered suitable for the fast-track system; dental/ medical negligence claims may often come into this category and have to be dealt with under the multi­track system.
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Multitrack: this is for cases which are complicated or where claims are in excess of £15,000.
On occasions, potential claims may start as a complaint.
In this case, dealing with the complaint fairly and expe­ditiously with a clear explanation, as recommended earlier, may mean that a claim does not arise. However, should the patient be dissatisfied, she/he may consult a solicitor for advice regarding whether or not a claim for damages should be made. The solicitor may request a copy of the patient’s health records from the health care provider (HCP), and these should be disclosed within 40 days. If this time limit is not kept, the pa­tient’s solicitor can apply to the court for an order for pre-action disclosure, and the HCP will be responsible for any costs involved in this. Should the patient or their legal adviser decide there are grounds for a claim, a detailed letter of claim should be sent to the HCP. This letter should contain:
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a clear summary of the facts of the case
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the main allegations of negligence
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the injuries incurred, present condition and future prognosis
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any financial losses and damage
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reference to any relevant documents.
The HCP then has 3 months to respond to this letter of claim before court proceedings are issued. During this period, either side may negotiate or offer to settle the claim. Either side may support its position with an ap­propriate dental/medical report. Should this not lead to the resolution of the matter, there are strict protocols and timetables that have to be observed, or the default­ing party may be liable to any additional costs of the other side.
Fast-Track Timetable
It is intended that any fast-track cases will come to trial within 30 weeks of the court issuing a Notice of Allocation
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following the submission of a claim. In fast-track cases, the trial is expected to last a maximum of 1 day. The timetable following the date of the Notice of Allocation is:
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4 weeks for the disclosure of documents by both parties
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10 weeks for the exchange of witness statements between the parties
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14 weeks for the exchange of expert reports between the parties
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20 weeks for sending a list of questions to the court and the other party for clarification
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22 weeks for response to questions from the other side or the court (note: each side is limited to one request for clarification and cannot delay matters by asking further questions at a later date)
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30 weeks for the court hearing, unless the case has been previously resolved.
Under the Civil Procedure Rules (2009), there is an ap­pendix setting out the fast-track standard directions, which it is expected that the parties will use to ensure that the timetable is adhered to.
Multitrack Timetable
It is expected that the majority of clinical negligence claims will be dealt with by the multitrack system even if they are below or equal to £15,000 in value. This is because they are regarded as too complex for the fast track. The multitrack timetable is not as tight as the fast track, but the court will have far greater control of cases than previously. Once a case has been allocated, a case management conference will be called. At the case management conference:
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both parties and/or their legal representatives will be expected to be present
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a substantial amount of information will be expected from all parties, including details of witnesses to be called and experts whose evidence will be heard; this means that parties must have their case in order at a very early stage, and this may facilitate settlement in some cases
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the timetable for the case will be set, which will be closely controlled by the court, who will not allow delay
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trial dates will be fixed at, or soon after, the case manage­ment conference, and these dates will be immovable.
To ensure that the case is dealt with expeditiously, the courts have power to impose sanctions should, for example, either party fail to comply with the pre-action protocol. These sanctions include costs, penalties and the disallowing of evidence.
To further speed resolution of a case, the court may suggest mediation, and it is expected that courts will build up a list of mediators suitable for different categories of claims. In addition, the trial judge will hold a pretrial re­view of the case. Normally, additional evidence or reports cannot be submitted following the case management con­ference without the permission of the court and the other parties.
These changes basically mean that the court will control the timetable and scrutinise the progress of the case. The court will now act without prompting by one of the parties, which means that the lawyers will no longer be able to determine the timetable of the case.

12.8 Laws and Regulations

LEARNING OBJECTIVES
You should:
• realise the extent that the law of the land governs you
as a dentist, an employer and an employee
• be aware of the need to seek professional advice
whenever it is appropriate
• understand agreements and contracts of employment
as they affect dental practice.
A dentist may be an employer and/or an employee, both of which involve a myriad of legislation. The Dentists Act of 1984, which has had several minor amendments over the years, makes the practice of dentistry illegal other than by registered practitioners and enrolled auxiliaries. It is this Act that gives the GDC the powers that have already been discussed.
A summary of other important legislation is listed be­low; as it is so extensive and complicated, appropriate pro­fessional advice should always be sought. This list should be used only as a guide to those situations or occasions when further details should be sought and/or appropriate professional advice obtained. Ignorance of the law is not acceptable for defence or mitigation.

EMPLOYMENT

All employees should have a written contract of employment.
There is a nationally agreed contract for the employment of foundation dentists, and the BDA offers specimen con­tracts for various types of employee and working agree­ments to its members on request.
Termination
There is specific legislation regarding the termination of employment, redundancy and unfair dismissal. Legal advice should be sought on this matter.
Discrimination
This now comes under the aegis of the Equality and Human Rights Commission in the United Kingdom, which was established under the Equality Act 2006. Under this legisla­tion, there are nine protected grounds against discrimination both within the workplace and in general:
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age
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disability
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sex
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race
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religion or belief
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pregnancy and maternity
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marriage and civil partnership
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sexual orientation
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gender reassignment.
Employers’ Liabilities
These include the safety of employees, customers and the general public, as well as the collection of income tax and National Insurance contributions.
12  •  Professionalism, Law and Ethics
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Premises and Working Environment
Legislation involving factories, offices and other workplaces prescribes standards of cleanliness, levels of occupation, the provision of appropriate protective clothing for employ­ees and the provision of sanitary facilities of any workplace. Specific legislation concerning, for instance, eye protection, air compressors, autoclaves and the safety of all electrical appliances are among those applicable to dental practice.
Health and Safety at Work Legislation
This states that every employer has a general duty to ensure the health, safety and welfare at work of all employees. There are many general and specific regulations under this umbrella. Every employer has to:
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provide and maintain safety equipment and systems of work
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ensure safe handling and storage of any potentially harmful substances
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maintain entrances and exits in a safe condition
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provide a working environment for employees that is no risk to their health
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provide instruction, training and supervision necessary to ensure health and safety.
The Health and Safety Executive has the duty to enforce legal requirements and provide advisory services. Its in­spectors have the power to enter premises and carry out investigations.
If an inspector notes a risk to health and safety, she/he can issue a Prohibition Notice preventing the continuance of that risk activity until remedial action as specified has been taken. In the case of a less severe risk, an Improve­ment Notice may be issued, which requires action within a specified time to remove that risk. Failure to comply with either of these notices within a specific time can lead to prosecution of the offender (employer).
Under the health and safety umbrella, there are several specific regulations that are particularly important to dentistry:
Ionising Radiations Regulations
The Ionising Radiation Regulations (IRRs) are concerned with the safety and maintenance of X-ray equipment, qual­ity assurance and the health and safety of employees and the general public.
The protection of patients is covered by the Ionising Ra­diations (Medical Exposure) Regulations (2000) (IRMERs). IRMERs came into force on 13 May 2000 and are mainly concerned with the protection of patients and specify the responsibilities of those ordering and taking radiographs. They are to ensure that only necessary examinations are undertaken and that the dose of radiation that the patient receives is kept to a minimum.
As there is no doubt that dental radiography is included in medical exposures, these regulations have to be fully cov­ered in all undergraduate dental courses in the United Kingdom. Additionally, all dentists and ancillary staff in­volved in ordering and/or taking radiographs for patients must undertake a formal radiation protection course of at least 5 hours of verifiable CPD covering these regulations every 5 years.
The IRRs and IRMERs were updated in 2017, and the new IRMERs came into force in February 2018. Since then, all organisations that use ionising radiation have to be reg­istered with the UK Health & Safety Executive and appoint a Radiation Protection Adviser (RPA). Also, these regula­tions lowered the maximum permissible doses to certain organs of the body.
Each organisation using ionising radiation has to have a Legal Person to ensure that this legislation is abided by and that good working practices are implemented. In dental practice, the Legal Person is usually the practice owner.
In dentistry the Legal Person must:
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ensure that there are written protocols for all radiation procedures
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keep training records of all staff undertaking X-ray examinations
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make up referral criteria for all X-ray examinations
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ensure there are written protocols for each radiographic examination and all X-ray equipment
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publish Diagnostic Reference Levels (DRLs) for each category of X-ray examination
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have procedures for investigating and managing any overexposures to ionising radiation
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keep an inventory of all X-ray equipment
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register the X-ray equipment with the Health & Safety Executive (HSE)
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appoint an appropriately qualified member of staff as the Radiation Protection Supervisor (RPS) whose duty is to ensure the implementation of ‘Local Rules’ for X-ray usage
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ensure that staff dosage is as low as reasonably practicable (ALARP)
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appoint an RPA to examine and test X-ray equipment, undertake risk assessments, quality assurance and train­ing. This needs to be undertaken at least every 5 years and when any new X-ray equipment is installed.
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appoint a Medical Physics Expert (MPE) to advise on patient dosage, X-ray examination techniques and radiation protection.
It is worth noting that a suitably qualified medical physicist can act as both RPA and MPE.
Any incident involving an excessive dose of radiation must be reported to the RPA/MPE, who will decide if the incident needs to be reported to the relevant statutory body.
There are three categories of staff involved in X-ray ex­aminations; however, in dental practice, they are often the same person.
Referrer: the person who refers the patient for the X-ray
examination and ensures that the referral is in line with
reference criteria. IRMER Practitioner: who must justify the need for an X-ray
examination, ensuring that the benefit to the patient
outweighs the detriment of that X-ray exposure. Operator: is the person who carries out the investigation on
the patient, and is responsible for identifying that it is the
correct patient, taking and processing the image, evalu-
ating that the exposure is appropriate and is responsible
for quality assurance of the equipment.
There are two terms that have specific meanings in regard to the use of ionising radiation in diagnosis.
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Justification: this is an estimation of the benefit to the patient
and includes:
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ensuring that the patient will benefit from the X-ray examination and that the benefit will outweigh the risk
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checking that the X-ray examination has not already been undertaken in the recent past
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ensuring that there is no suitable diagnostic alternative to the exposure.
Optimisation: the operator must ensure that:
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The dose is as low as reasonable practicable.
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The technique is in line with protocols.
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They have sufficient skill to carry out the procedure.
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The exposure is within diagnostic reference levels.
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There is a clinical evaluation of the image(s) and ensure that those findings are recorded in the patient’s records.
Control of Substances Hazardous to Health Regulations 2002 (COSHH)
Within these regulations are occupational exposure limits and maximum exposure limits. In dental practice, for ex­ample, substances such as glutaraldehyde, mercury, meth­ylacrylate, phenol and trichloracetic acid are common and could cause hazard if mishandled. The employer has the duty to make a risk assessment on all hazardous substances and to reduce any identifiable risk as much as possible.
The Control of Mercury (enforcement) Regulations 2017
Since July 2018, dental amalgam must not be used for dental treatment in:
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primary dentition
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children under 15 years of age
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pregnant or breastfeeding women.
Amalgam may be used when deemed strictly necessary by the dental practitioner based on the specific medical or den­tal needs of the patient. If advising the use of dental amal­gam in any of the above groups, discussion with the patient or their legal guardian is required and consent is essential.
Reporting of Injuries, Diseases and Dangerous Occurrences Regulations (2013)
Any serious injuries, accident, work-related diseases or dan­gerous incidents that could potentially cause harm arising out of or in connection with work affecting the employer, an employee or a member of the public on the premises must be reported to the Health & Safety Executive.
Freedom of Information Act (2000 or 2002 in Scotland)
Dentists who provide NHS treatment are considered to be a ‘public authority’ and are therefore covered by this legisla­tion. This Act allows patients to examine any records held by the practice and allows the primary care organisation and individuals to request information such as NHS contract value and Unit of Dental Activity (in NHS dental treatment) (UDA) targets. Dentists are also able to request information held by the primary care organisation.
Care Quality Commission
This body is the independent regulator of health and adult social care in England; it is an executive non-departmental public body sponsored by the Department of Health and
Social Care of the United Kingdom. It was established in 2009; its purpose is the regulation of organisations and the premises where health and social care is undertaken. The Care Quality Commission (CQC) set out fundamental standards of care which encompass quality and safety. They also monitor, inspect and regulate services to ensure these standards are met. Their findings are published and publicly accessible. The CQC has had a rolling programme of inspecting dental practices since 2015. These inspec­tions are judged in five key areas—is the practice:
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safe
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effective
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caring
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responsive
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well-led.
The CQC remit covers all health and social care organisa­tions, not just dentistry. Its fundamental standards are to insure that there is:
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person-centred care
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dignity and respect
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need for consent
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safe care and treatment
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safeguarding service users from abuse and improper treatment
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meeting nutritional and hydration needs
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suitable premises and equipment
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receiving and acting on complaints
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good governance
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staffing
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fit-and-proper persons employed.
There is a Primary Care Dental Services Provider Hand­book available from CQC covering details of what is expected to demonstrate that a practice is well-led and compliant.
At the time of writing, the information taken from the CQC website shows that the CQC currently registers and regulates:
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hospitals
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dental practices
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ambulance services
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care homes
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children’s services
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healthcare clinics
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services based in the community
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GP and doctor services
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hospices
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mental health services
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services in secure settings
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home care services.
Further information about the Care Quality Commission is available on their website (www.cqc.org.uk).
Disclosure and Barring Service (DBS)
The Disclosure and Barring Service is an executive non­departmental public body sponsored by the Home Office of the United Kingdom. Previously, this facility was provided by the Independent Safeguarding Authority and later by the Criminal Records Bureau. Any individual working with vulnerable groups, for example, treating or caring for children or vulnerable adults, has to undergo checks by this organisation. They will check whether the applicant