You should adhere to your NHS job plan unless variations have been agreed in writing with the appropriate person within the Trust. Consultants who juggle their private practice with NHS commitments on an ad hoc basis  can find themselves facing disciplinary action on the basis that if the job plan says you should be on Trust premises, and you are not, you are ‘stealing time’ from the NHS.

Some patients will ask to bypass NHS waiting lists by becoming a private patient. Most trusts have a policy governing transfer of NHS patients to the independent sector, which you should be familiar with and follow, as breaching it can again result in disciplinary proceedings.

It is best to establish yourself in your NHS practice before starting working in the independent sector. Getting to know your NHS Trust, your colleagues, and the local private hospitals equips you to start private practice without treading on other peoples’ toes. Establishing a positive reputation with consultant and GP colleagues will also make establishing a private practice a smoother process.

If you decide that you do want to work in the independent sector there are a number of options:

The NHS outsources approximately 25% of it s surgical workload to private hospital groups. Typically the hospital will contract with a surgeon to consult with NHS patients and where appropriate proceed with surgery. The benefit of this type of work is that the patients are found for you, you are working in a managed environment which means that you will probably not need to register with the CQC and most of these arrangements you will be covered by the NHS Indemnity Scheme so you will not have to pay private practice indemnity subscriptions – but this cannot be assumed, so before accepting choose and book work confirm the indemnity arrangements in writing.

Waiting list initiatives are additional surgery sessions to reduce backlogs. There are two categories:

• Additional NHS surgical lists within the NHS Trust. The NHS pays the consultant a fee for each surgical session and the surgeon is usually indemnified by the Trust
• Outsourcing of NHS work to private hospital groups. The difference here is that the private hospital is responsible for paying the consultant and the surgeon will not normally be indemnified by the NHS and must have his/her own indemnity in place.

It is imperative that indemnity arrangements are confirmed in writing for choose and book work and waiting list initiatives. There have been a number of cases where surgeons have assumed that they were covered by NHS indemnity only to discover in the course of a claim that they were not, leaving them personally liable for compensation awards and legal costs.

There are a number of private organisations that offer cosmetic surgery packages and contract with consultants to operate on patients who have been recruited through advertising.

These providers vary in the extent to which they expect surgeons to be involved with pre-operative and post-operative care. You should also check their advertising to ensure that it complies with the standards you would expect of a reputable provider.

The surgeons are usually asked to sign a contract, which sets out the terms under which the surgeon provides these services to the company. These contracts may contain clauses, which, for example, require the surgeon to indemnify the company against any losses (not limited to the surgeon’s own negligence). Such clauses may conflict with the surgeon’s insurance contract and so it essential to seek further advice before committing yourself to such terms.

PRASIS has its own Code of Practice, which sets out standards to which PRASIS members are expected to adhere.

To develop your own private practice you need a business plan. This will include the scope of services you want to provide, where you will see your patients and where you will operate, which in turn will require you to apply for admitting privileges at local hospitals. Your commitment to the private sector must not conflict with your NHS job plan but must allow time to see patients post-operatively where necessary and deal with emergencies, which may arise.

You will need to determine your fee structure, which should be created independently of your colleagues (to avoid problems with competition law). From this and the estimated volumes you can project your gross earnings.

You will need indemnity in place: private hospitals currently require plastic surgeons to have a minimum indemnity limit of £10 million in place. However ,your indemnity fees will depend on the procedures you undertake, the volumes and your private practice income. Insurance contracts are contracts of the utmost good faith, which means that that they can be declared void if there are significant inaccuracies in the data submitted. Indemnity is expensive but can be set against gross practice income.

You will also need administrative support, which may be provided to some extent by your private hospital and have arrangements in place with colleagues for covering when you are away.

Your accounts need be accurate, which will require book-keeping and accountancy support. The costs of running a practice are significant and an accountant will guide you on the expenses which can be set against tax. Over zealous claiming for expenses and inaccurate record keeping is likely to result in a HMRC investigation which will prove stressful, time consuming and costly.

You will also need to consider whether you should be registered with the CQC and/or the Information Commissioner (see below).

Data on your practice will in future be provided to the Private Healthcare Information Network (PHIN – see below) by your private hospital(s) and or NHS Trust Private Patient Unit. These data will be published on the PHIN website so it is important that you check your data for accuracy and rectify any inaccuracies with the hospital providing incorrect data.

Before you can see patients at a private hospital you nee d to apply for admitting privileges. This involves submission of your details including your indemnity certificate and agreeing to the hospital’s terms of business. Admitting privileges are granted at the discretion of the hospital management and can be suspended or removed at any time, without a right of appeal although most hospitals do have a process for reviewing these decisions. If your admitting privileges are revoked temporarily or permanently you are under a (GMC) duty to inform all other private hospitals where you work and also your NHS trust. Equally, if you are excluded from your NHS trust or have any restrictions imposed on your practice you are obliged to inform the private hospitals where you work.

In most specialties, a surgeon’s independent sector practice should mirror their NHS practice. However, for many plastic surgeons NHS and private practice are different and as expectations amongst patients seeking cosmetic procedures are high (and in some cases unrealistic), it pays to stick to procedures at which you excel. It also pays to have a low threshold for referring patients on to more experienced colleagues if you are in any doubt that you can satisfy their needs.

Referral to clinical psychologists may also be advisable in some cases eg where body dysmorphic syndrome is suspected.

The consent process (see below) also provides an opportunity to manage expectations by giving an objective and perhaps slightly pessimistic prediction of the likely outcomes.

You are not under any obligation to undertake a procedure, which you believe to be against the patient’s best interests and it’s best to resist attempts to pressure you into surgery against your better judgement.

Some consultants employ nurses in their private practice who undertake a variety of tasks including botox and filler injections and peels delegated by the  surgeon. This is acceptable practice provided that:

• the delegating surgeon has satisfied him/herself that the person undertaking the procedure is competent to complete it to the required standard
• that the individual to whom the task is delegated is indemnified, and,
• that the patient has been properly consented, which includes ensuring that patient understands who will be carrying out the procedure.

The same principles apply to trainees who are either assisting a consultant in the private sector or carrying out delegated procedures under supervision, remembering that there is no lower standard for procedure carried out by a trainee.

Your admitting privileges agreement(s) may also place restrictions on the involvement of trainees in private hospitals.

In general the consultant’s indemnity will not cover cosmetic nurses or trainees for work they undertake in the independent sector, so it is imperative to ensure that all clinicians involved in providing care have their own indemnity in place.

Consent is fundamental to the law governing medical treatment protecting patients against unwelcome intrusion. The basic principles are straightforward: the patient must be competent; have all necessary information to make an informed choice and the consent must be given freely. Most consent claims centre around the information provided to the patient. Following the Montgommery judgment, the RCS has provided guidance on taking consent including:

• The aim is to give the patient the information they need to make a decision about what treatment or procedure (if any) they want.
• The discussion has to be tailored to the individual patient. This requires time to get to know the patient well enough to understand their views and values.
• All reasonable treatment options, along with their implications, should be explained to the patient.
• Material risks for each option should be discussed with the patient.
• Consent should be written and recorded. If the patient has made a decision, the consent form should be signed at the end of the discussion. The signed form is part of the evidence that the discussion has taken place, but provides no meaningful information about the quality of the discussion.
• In addition to the consent form, a record of the discussion (including contemporaneous documentation of the key points of the discussion, hard copies or web links of any further information provided to the patient, and the patient’s decision) should be included in the patient’s case notes. This is important even if the patient chooses not to undergo treatment.

Consent is much more than a signature on a consent form. Fulfilling the requirements set out above involves the explanation about the proposed treatment and available alternatives to be an integral part of clinical care tailored to the individual patient.

In the event of a complaint or claim, the defence have to demonstrate that, from the initial consultation through to the final post-operative consultation, the patient was provided with all the information required to make an informed decision about their treatment and contribute to their own care as and when required.

Numerous studies have shown that patients retain comparatively little of the information provided to them during a consultation.  So it’s useful to write to patients with a summary of the consultation, reinforcing key points – the fact that this documentation exists reinforces the surgeon’s commitment to making sure that patients do have all the information they require.

Concerns over the safety of PIP implants and the potential for a significant number of compensation claims, put product liability in the spotlight. 

Product liability allows people who suffer harm, or damage, as a result of a defective product to sue for compensation: they do not have to prove negligence or fault, just that "the safety of the product is not such as persons generally are entitled to expect". “Damage” includes death, personal injury and, to a limited extent, damage to property but the legislation does not allow claims for pure economic loss.

Implants and all other medical devices are products under the act, so patients injured by defective implants can sue for compensation.

Liability falls to the manufacturer or, if the product was made outside the EU, the importer into the EU. Simple though this may sound, chains of supply can be long and it may not be possible to identify the producer. Under these circumstances, the supplier can be jointly and severely liable, which is why independent sector hospitals carry product liability insurance, and why any surgeon buying in and supplying implants should also have insurance in place to cover a product liability claim.

The producer can avoid liability through a number of defences including a “state of the art defence” This is simply that the state of scientific knowledge at the time the product was supplied, was not such that the defect could reasonably have been identified.

Practical implications of Product Liability

Plastic surgeons could find themselves embroiled in product liability claims if they supplied, or were thought to have supplied, a product of any sort.

• All surgeons implanting medical devices should keep records of the product supplied: the necessary information may be provided on bar codes supplied with individual products.

• Products should be used in compliance with the manufacturers’ instructions, to ensure that warranties are effective, and that product liability rests with the manufacturer.

• Products should not be modified, or combined with components supplied by other manufacturers, unless these modifications or combinations are approved by the manufacturers.

• Any surgeon, limited company or LLP buying in and supplying products should carry product liability insurance, as this does not form part of standard professional indemnity.

It is a GMC requirement to hold professional indemnity so that in the event of a patient being harmed through negligence there is the means to provide adequate compensation.

PRASIS members hold a claims made policy of insurance which provides up to £10 million to meet claims made in any one year. It is a claims made insurance policy, which means that the policy will respond to claims made in the policy years arising from clinical care provided during the period of PRASIS membership: in other words you are covered for any procedures undertaken from the date of joining.

As it is a contract of insurance the rights to access the indemnity are legally enforceable provided that the insured surgeon has complied with his/her obligations under the policy. In essence this means declaring accurate details of income, scope of practice, past history etc on the application form and on each renewal, notifying the insurer of any adverse event, which might give rise to acclaim on the policy as soon as you become aware of it and co-operating with the insurers and their lawyers in the event of a claim being made. Failure to comply with these obligations can leave the surgeon unindemnified and personally liable for adverse awards of costs and damages as well as his/her own legal costs.

The UK defence organisations provide discretionary occurrence based indemnity. There is no contract of insurance, so there is no guaranteed right to indemnity or other assistance, but with occurrence based indemnity you are entitled to ask for assistance even after you have left membership.

This is a topic, which is covered in the PRASIS Code of Practice. The Advertising Standards Authority and the GMC require all advertising by doctors to be legal decent and honest.  Advertising is about providing information about the scope of your practice, and where and when you are available for consultation.

Exaggerated claims or comparisons with other providers should be avoided. There is no place for two for one, or time limited offers or any other form of pressurised inducement.

Where you are working for another provider you should ask to see their advertising materials to ensure that the same standards are adopted.

The Data Protection Act 1998 is a wide ranging piece of legislation setting out the obligations of all individuals and organisations that hold data about identifiable individuals. It provides data subjects with a degree of control over the information held about them. The act is not specifically about clinical records, but some specific provisions that relate to clinical records do exist within it and in subordinate legislation (Statutory Instruments).

The act extends to manual and computerised data files. Data controllers (in the medical context this can include individual doctors) are required to comply with the Data Protection principles and, with some exceptions, inform data subjects when their data are processed.

Putting the act into practice boils down to complying with its eight central principles, but you can be reasonably sure that you are complying with the requirements of the act as long as you:

• Are validly registered as a data controller by notifying the Information Commissioner's head office at: Wycliffe House, Water Lane, Wilmslow, Cheshire SK9 5AF (telephone: 01625 545 745). There are also offices in Scotland, Wales, and Northern Ireland. Only doctors who personally hold patient records need to be registered)
• Ensure that the data you hold are accurate and up to date
• Hold no more information about patients than you need for their medical care and use it only for that purpose
• Store records securely and confine access to authorised personnel
• Comply with patients' legitimate requests for access.

The principal terms in the Data Protection Act are defined as follows:

Personal data

Data that relate to a living individual who can be identified either from the data alone or from combining the data with other information held by or likely to be held by the data controller. It includes any recorded expression of opinion by or about the individual. Personal data may be held in electronic or manual form, or both.

Sensitive personal data

Data consisting of information about a person's racial or ethnic origin, political opinions, religious beliefs, membership of a trade union, physical or mental health or condition, sexual life, criminal record, or legal proceedings pending. Sensitive personal data may be held in electronic or manual form, or both.

Data subject

The person who is the subject of the personal and sensitive data.

Data controller

A person who (either alone or jointly with others) determines the purposes for which, and the manner in which, any personal data are processed or are to be processed.

Notification

Notification to the Information Commissioner sets out what data are held and the purposes for which they are held. Medical practitioners are not exempt from the notification requirements.

Clinical records should be kept in a secure environment. This not only means restricting access to authorised personnel, but taking care to maintain the physical integrity of the data. You should take all reasonable precautions against damage by fire (for example having an alarm system, sprinklers, no smoking signs) and other elements such as damp. It would not be appropriate, for example, to store old records in a damp basement.

All staff must be aware of their duty not to allow unauthorised disclosure or access to personal data or sensitive personal data. Passwords, encryption software, restricted access, and so on are issues to consider, but there are less obvious problems for example repairs to equipment: ideally, if the equipment contains personal data, repairs should be supervised on the premises, or carried out in a secure environment under a confidentiality agreement.

Disposal of records does not necessarily mean destruction. It could mean, passing them on to another organisation, such as the Public Records Office, a university, or an established research institute.

When data are being destroyed, take care to ensure that confidentiality is maintained. If you are contracting the job use a speciality security firm.

Information held on computers will not be expunged from the hard disk merely by deleting the file or reformatting the disk. It is possible to resurrect the data using commonly available software, so do not sell on old computers. It may be safer to destroy the hard drive, but if this is not feasible you must first ensure that any personal data remaining on the disk are inaccessible.

The Care Quality Commission monitors, inspects and regulates services that provide medical treatment in England, including care and support provided by NHS and private hospitals.

Any person who provides regulated activity in England must be registered with the CQC: failure to do so is an offence. The system of registration is designed to ensure that only those people who are fit and are likely to provide good quality care are authorised.

To be registered, an application must be made to the CQC, with details about the applicant, the regulated activities applied for, and the places at which it will be provided.

The CQC assess the applicant and grant registration if satisfied about their fitness  (as set out in the Health and Social Care Act 2008) and compliance with the requirements of the relevant regulations and enactments.

Registration is conditional conditions on the locations at which regulated activity may be provided.

As an individual surgeon you should register if you will be carrying on the regulated activity yourself.

The GMC require you to “You must respond promptly, fully and honestly to complaints and apologise when appropriate.  You must not allow a patient’s complaint to adversely affect the care or treatment you provide or arrange.”

Complaints are a fact of life in clinical practice. In cosmetic practice the incidence of complaints is much higher than other surgical specialities and is more frequently a prelude to a claim for compensation or a demand for reimbursement of fees. Consequently, all complaints concerning clinical care or the outcome of surgery should be reported to insurers as soon as possible.

The essentials of complaint handling are straightforward:

• Be sure you understand the complainant’s perspective ie what the patient is complaining about
• Contact your indemnifier
• Establish all the facts before attempting to explain what happened
• Once you know what happened, provide a full explanation to the complainant as soon as possible
• Apologise when this is indicated
• Remain professional throughout
• Keep a record of the complaint and response

Patients may seek a variety of remedies including revision procedures and/or reimbursement of fees and out of pocket expenses. Whether revision surgery and reimbursement are appropriate will vary from case to case and so there is no substitute for discussing individual cases with your medico-legal advisor.

The law governing clinical negligence has only one remedy for patients and that is providing financial compensation to people who have suffered harm as a result of an inadequate standard of care.

To succeed the claimant needs to prove that:

• The provider of care owed a duty of care to the patient (which is rarely in doubt)
• The provider breached the duty of care (by proving a poor standard of care), and that
• The patient suffered harm as a result of the poor standard of care.

Determining whether or not there was negligence is a legal matter, which requires expert medical advice. It is not a matter for individual clinicians, who are themselves subject to criticism to comment on. As soon as the word negligence is mentioned, you should contact your indemnifier straightaway – Delayed notification of any incident, which could give rise to a claim on your policy could affect your entitlement to indemnity.

Handwritten records must be legible, signed and dated. Computerised records are sometimes too brief and fail to record sufficient details about the history, examination findings, and information given to the patient, including warnings about adverse effects and what to expect from the particular signs and symptoms that might require urgent review.

Apart from lacking sufficient information, clinical records may be inadequate if they are ambiguous, or contain facts that are wrong.

Offensive or pejorative comments can undermine the doctor-patient relationship and can give rise to complaints to the GMC or even to litigation. Remember that patients have a right of access to their records: so you should always assume that anything you write will be read by the patients and/or their legal advisors.

Records should be contemporaneous because the longer the gap between the consultation and recording it, the greater the chance of forgetting important details or confusing one patient with another. When records are needed in legal proceedings, their value as evidence falls considerably if they were made after the consultation.

Relevant clinical findings include all the pertinent elements of the history and examination. If it is hard to know from the record whether any examination took place, it may be hard to convince others that it did.

Clinical records should also include the information given to the patient, including warnings given to patients before surgery or investigations. This will usually include the doctor's assessment of the current situation and the suggested clinical management, including investigations, referral, medication or other treatment, and an account of what the patient was told to expect: this may include when things might improve, any adverse effects of the medication prescribed, any important symptoms to report back urgently, as well as arrangements for follow up.

Reinforcing the advice given to a patient in a personalised letter to the patient after a consultation can prove invaluable, for example, if there is a dispute about warnings provided prior to surgery. To confirm that the patient has received the letter you can conclude it by asking the patient to contact your secretary to book their admission if they wish to proceed.

Following an investigation into private healthcare market in the UK by the Competition and Markets Authority (CMA) between  2012 and 2014 the CMA proposed a number of remedies to the issues they identified. Although not the initial focus of the investigations, the final report found “a lack of independent, publicly available performance and fee information”

The subsequent Private Healthcare Market Investigation Order 2014 created legally enforceable remedies to improve the information available to patients, including:

Improved collection of data

• Publication of and performance measures, including PROMs
• Publication of fees
• As the Information Organisation for Private healthcare in the UK, PHIN has a duty to:
  • collect data from of privately funded care
  • publish performance measures to help patients make informed decisions
  • publish by and for

It is intended that implementation will be complete by 30^th April 2019.