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Legal Issues and Contact Lenses
31
Legal Issues and Contact Lenses MICHAEL MIHAILIDIS
CHAPTER OUTLINES
Negligence, 529 Standard of Care, 529 Failure to Give Advice on Alternative Modalities, 531 Contact Lenses and Transmissible Diseases, 532
This chapter will endeavour to cover the legal aspects of fitting and prescribing contact lenses. To do this, an explanation of the tort of negligence (malpractice) is required with recent precedent case law. This is the basis of most claims that are ‘negligence-based’. Examples of the law in its application are given to emphasise certain contact modalities. It is important for practitioners to understand the process in which litigation ensues; if they can identify with the basic legal requirements and incorporate them into their mode of practice, the claims against them ultimately will be diminished. Contact lenses are medical devices. The contact lens practice issues that fall under the tort of negligence may instigate legal and ethical debate; these issues fall into three categories: 1. the patient: ■ understanding the needs of each individual patient ■ competence in fitting the lenses ■ the determination of the optimal visual correction. 2. the prescription: ■ how the prescription is written ■ its interpretation ■ dispensing by third parties including online, internet sites. 3. record keeping. Lastly, medical records are discussed as the starting point for medicolegal negligence litigation.
Negligence Negligence or malpractice is the term used to describe all possible civil liabilities practitioners can incur as the end result of their professional services. Health professionals may be held liable if their patients suffer harm as a consequence of their health care. There are two areas of law in which practitioners can be held accountable: civil and criminal law. For the purposes of this chapter, we will concentrate on civil law, which encompasses tort law. The area of tort law pertaining to contact lens practice is negligence. An explanation of how negligence is determined is necessary to understand precedent case law. To make a successful claim of negligence, a plaintiff (the patient) must be able to prove that:
The Contact Lens Prescription, 532 Safeguarding the Practitioner, 532 Record Keeping, 533 Summary, 534
The defendant (the practitioner) owed the plaintiff a duty of care that the defendant breached by failing to exercise the necessary level of care. ■ The plaintiff suffered damage that was inadequately met as a result of the defendant’s breach. This cannot be remedied, hence, damage in the form of monetary compensation would be the primary solution. ■
‘Duty’ is defined as ‘an obligation, recognised by law, to avoid conduct fraught with unreasonable risk of danger to others’. On the issue of whether the practitioner (defendant) owed the patient (plaintiff) a duty of care, the plaintiff will need to establish foreseeability of harm and the proximity between plaintiff and defendant. There is thus a duty to ensure that one’s acts do not cause foreseeable harm to another. The foreseeability element will be established if the patient is a member of a class to whom damage was foreseeable. The foreseeability element is only part of establishing the existence of a duty of care. It is also necessary to show that the relationship between the parties had the necessary degree of proximity. A patient has a proximal relationship with a clinician because a patient would quite clearly be someone who would be injured by a failure on the part of the clinician to take reasonable care.
Standard of Care What is it, and why is it applicable to everyday contact lens practice? There has been a flurry of recent precedent law in favour of letting each patient remain an individual and be treated as such. Prior cases emphasised the concept of paternalistic medicine whereby it was assumed that ‘the doctor knew best’. The shift to treating the patient as an autonomous being allows patients to make necessary decisions, provided they have at their disposal all material facts. The standard of care required is one of reasonableness. In determining a breach of duty, did the practitioner act with the level of care that one would expect of a ‘reasonable person’? In the case of Bolam v Friern Hospital Management Committee (1957), the court considered the standard of care for doctors. Under the Bolam test, a practitioner: …would not be negligent if he or she has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art…a man is not negligent 529
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if he is acting in accordance with such a practice, merely because there is a body of opinion who would take a contrary view. This test had the effect of embodying the ‘reasonable man test’ or the ‘reasonable practitioner’. It was an objective test. This principle was approved by the UK House of Lords in respect of diagnosis, treatment and information disclosure. The Bolam test was applied in the case of Sidaway v Board of Governors of Bethlem Royal Hospital (1985) in its consideration of the provision of information. This case involved a plaintiff suffering damage as a result of a spinal operation. The plaintiff alleged failure of the surgeon to fully disclose the risks associated with the operation. The trial judge rejected the plaintiff ’s claim on the basis that, at that time, it had been established that a responsible body of neurosurgeons had agreed that their colleague’s standard of disclosure was acceptable. Under the Bolam test, the professional practices and opinion against which a clinician would be judged must be a ‘responsible body’, much like a ‘peer review committee’, but this need not be a substantial body of practitioners fitting contact lenses. For example, a small group of practitioners who fit keratoconic lenses may be considered ‘super-specialists’ in fitting complex gas permeable lenses; hence, for the purpose of the Bolam test, the defendant’s actions would be judged against the opinion of this group of practitioners rather than against the whole group of practitioners who fit contact lenses generally. However, the Bolam test has been criticised in subsequent cases in the UK, the USA and Australia. In the Sidaway case above, Lord Scarman rejected the Bolam principle in respect of the provision of information stating that: …English law must recognise a duty of the doctor to warn his patients of the risk inherent in the treatment in which he is participating…The critical limitation is that the duty is confined to material risk. The test of materiality is whether in the circumstances of the particular case, the court is satisfied that a reasonable person in the patient’s position would be likely to attach significance to the risk. Likewise, the Canterbury v Spence (1972) case involved a 19-year-old suffering damage as a result of a laminectomy. The judge in that case considered the scope of the disclosure required of the physician. The definition of ‘scope’ was in terms of the patient’s rights to self-determination and therefore propounded the concept that the degree of information depended on the needs of the particular patient and the particular procedure. He said: A risk is thus material when a reasonable person, in what the physician knows or should know to be the patient’s position, would be likely to attach significance to the risk or cluster of risks in deciding whether or not to forgo the proposed therapy. Similarly, in Reibl v Hughes (1980), in which a patient suffered a stroke following a left carotid endarterectomy and where medical evidence estimated the incidence of the complication as 10%, the judge stated: To allow medical evidence to determine what risks are material and, hence should be disclosed and, correlatively, what risks are not material, is to hand over to the medical profession the entire question of the scope of the duty of disclosure, including
the question whether there has been a breach of that duty… What is under consideration here is the patient’s right to know what risks are involved in undergoing or forgoing certain surgery or other treatment. In Australia, the rejection of Bolam came as a result of Rogers v Whitaker (1992), where the High Court considered the case of Maree Whitaker, who had been blind in her right eye since childhood. She had been referred to Dr Rogers, an ophthalmic surgeon, who recommended an operation on her damaged eye to prevent the possible development of glaucoma. The surgery was claimed to be likely to improve the vision in her damaged eye and also to improve its cosmetic appearance. Postoperatively, she developed sympathetic ophthalmia – a rare condition with an incidence of about 1 in 17,000. The result was a loss of sight in her left eye and almost complete blindness. The plaintiff sued for negligence, alleging that Dr Rogers had failed to warn her of the risk. She claimed that, had she been warned of this possibility, she would never have consented to the surgery. The High Court approached the task of the content of duty and its scope in these matters of ‘failure to warn’. In defining the factors involved in a doctor’s duty to warn, the High Court repeated: A doctor has a duty to warn a patient of a material risk inherent in the proposed treatment. A risk is material if, in the circumstances of the particular case, a reasonable person in the patient’s position, if warned of the risk, would likely attach significance to it or if the medical practitioner is or should reasonably be aware that the particular patient, if warned of the risk, would be likely to attach significance to it. The evolution from Bolam to Rogers was gradual, and the courts came to hold the professions more accountable for adverse events arising out of their activities. In Rogers, the High Court – in discussing ‘material’ risk – held that the subjective text was the model most appropriate when it stated: ‘a particular patient, if warned of the risk would find it of significance’. Medical ethicists have since endorsed this patient-orientated approach. They see the consent process as a change from a single event of paternalistic beneficence to an integrated process of information sharing and informed decision making. This standard is now a consent, based on an autonomous patient making an informed decision based on understanding. Although the practitioner may in depth and comprehensively impart information, there is no guarantee that patients will understand all they have been told. Patients may also be presented with hard copy data in the form of information sheets, but the problem is that they may be too exhaustive and become incomprehensible. However, it is suggested that the provision of detailed brochures, as well as specific and detailed consent forms, is the minimum required in informing a group of patients for, say, an orthokeratology procedure. Patients may have unrealistic expectations of the result they would like to achieve and may be resistant to modifications or perceived compromises pre-discussed. On the other hand, the practitioner may be unreasonably optimistic in the portrayal of the outcomes. Many patients seeking to wear contact lenses are unrealistic in their appreciation of the visual outcome. Likewise, a full appreciation of worst case scenarios should almost always be depicted to the patient, as visual loss is the
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common denominator and generally why we look after these patients in preventative practice. Since Rogers v Whitaker, cases of medical negligence have come to include allegations of ‘failure to warn’, almost always as a part of a claim. The application of this negligence metamorphosis is not confined to contact lens practice but to all aspects of patient care. In this change in determining standard of care, we can see how Rogers v Whitaker (at least in Australia but similarly in most other countries) can influence all duty of care situations.
Failure to Give Advice on Alternative Modalities Current legal thinking emphasises the critical role of patient autonomy in health care decision-making. This emphasis extends as far as creating an obligation for the practitioner to advise a patient about complementary and alternative visual corrections such as contact lenses. The law imposes on the practitioner a duty to exercise reasonable care and skill, not only in examination, diagnosis and treatment but also in the provision of professional information and advice, being a ‘single comprehensive duty’. It is the patient who must make the decision, but it is the clinician who holds the information on which the decision must be made. In Haughian v Paine (1987), it was ruled that ‘one cannot make an informed decision to undertake a risk without knowing the alternatives to undergoing the risk’. The area pertinent to the practitioner is the use of contact lenses as therapeutic devices rather than for simple cosmesis. Consider the supply of spectacles to a moderate or severe keratoconic patient. In this case the practitioner may be considered negligent if he has not provided the optimal visual correction (contact lenses). The same would apply to an aphake or corneal graft recipient. Nevertheless this should be qualified by careful explanation about the trial of contact lenses, their effect, associated risks, complications of fitting, costs, time involved, etc. These must all be conveyed in such a way that patients have all the facts at their disposal. Should they opt not to undergo any form of contact lens fitting, that is their decision, but the practitioner has at least satisfied the minimum legal requirements under Rogers v Whitaker. It is incumbent on the practitioner to do whatever is necessary for the patient’s ocular well-being. Practitioners have a duty to investigate what needs to be prescribed and may also need to refer to someone more competent if their skill in a particular area is limited. Keratoconus is a classic example where special expertise and advice are required. Practitioners should not assume that contact lens correction is automatically essential and should consider whether corneal cross-linking would be of benefit instead of contact lenses. Alternatively, if the visual acuity is reasonable with spectacles, the patient may be happy to wear this correction, and exposing the patient to the potential complications of contact lenses could leave the practitioner at risk. Similarly, if patients are unable to attend for regular aftercare, potential ocular damage could result, so again contact lenses should not be advised. How much information should be given and should a lens trial be conducted so that the patient fully understands what to expect? The patient must be given a realistic idea of what to expect when wearing rigid lenses, the risks involved and
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also an understanding of the variation in such factors as individual corneal sensitivity in determining success or failure. As mentioned earlier, practitioners must be pragmatic with their patient’s understanding of the limits of treatment. Equally, they must not allow themselves to become so enthusiastic about correcting the person’s vision that the end result is a disappointed patient whose expectations are not met. The contact lens fitting philosophy used could possibly influence future corneal scarring. Should RGP lenses be fitted with apical clearance or apical touch, for example? What is important here is that whichever technique is used, the practitioner must adhere to and become clinically competent at fitting the chosen philosophy. Under the Bolam principle, the practitioner would not be required to explain the type of fitting design or the possibility of scarring as this would be considered clinically acceptable by an expert group of ‘sub-specialists’. If we apply Rogers v Whitaker, the practitioner must explain possible and probable visual outcomes as well as the possibility of corneal scarring. Scarring would be considered a material risk in undergoing a keratoconic fitting, especially if, as mentioned earlier, the patient had reasonable vision with spectacles. These examples are for therapeutic purposes; what of the situation where a person wears contact lenses for cosmetic reasons only? Is there a duty to at least advise of alternative lenses such as daily wear silicone hydrogels (compared with conventional hydrogels), or does the practitioner say nothing? This situation would be harder to contest by a plaintiff patient, as the long-term implications have not been quantified significantly to measure possible future harm or damage to the patient.
WHAT LENSES SHOULD A PRACTITIONER PRESCRIBE? When should a rigid gas permeable (RGP) or scleral lens be fitted as opposed to a soft lens? The reasons vary as to the person’s prescription, age and occupation. Take an example of a 6-year-old child whose prescription is: R +9.00/−4.00 × 175 L +8.75/−5.75 × 180 They may attain ‘adequate’ aided acuities with each eye with a toric soft lens, but the underlying ocular integrity and ‘legal’ basis for prescribing a soft contact lens is not always the optimal standard required by a practitioner. For the following reasons, it may be in the best interests of the patient to prescribe a rigid lens: He/she may see better out of a rigid lens. Stability may be better with a rigid lens. ■ Rigid lenses may be easier to insert. ■ Vision may be better with a rigid lens which may reduce possible amblyopic issues. ■ Prescribing a soft toric lens for the patient above may compromise the acuity. More importantly, do the parents know that their child might achieve a ‘better’ aided acuity? Has the groundwork been laid in explaining the pros and cons of both types of lenses? ■ ■
What do you do with a patient with a recent corneal transplant with the sutures still in place? The patient relies on vision for work.
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If you prescribe a soft lens, the lens will come into contact with the sutures, causing possible neovascularisation and graft rejection. ■ If you prescribe a standard RGP lens, the lens may not fit adequately and may cause similar problems. ■ A scleral lens (fitted properly) will not come into contact with the sutures and can achieve a good outcome. However, there is still a physiological risk. ■
The patient needs to be carefully informed and to understand the advantages, disadvantages and risks of each lens type. In other situations there may be only one type of lens that is considered suitable, and this must be explained to the patient together with the reasons. In specific areas, such as myopia control and multifocal lenses, warnings should be given that there is no guarantee of achieving total success. In these more complex cases the general advice therefore is to do the following: Present all the alternative choices to the patient. ■ Explain the advantages, disadvantages and risks of each option. ■ Always try a spectacle correction first if it will give an acceptable result. ■ If you consider that there is only one option, then explain your reasoning. ■ Explain the need for regular monitoring. ■ Refer to a colleague if the condition is not in your area of expertise. ■
The results may not be what was intended or designed, and these messages conveyed and understood by the patient go a long way in preventing a foreseeable injury caused by your treatment.
Contact Lenses and Transmissible Diseases In an era when it is understood that diseases may be transmitted by fluids, practitioners should be cautious for themselves, their patients and the actions of their patients. Diseases that can readily be transmitted by fluid should always be considered when fitting contact lenses (see UN, WHO (2012); and also Chapter 4). These include new variant Creutzfeldt–Jakob disease (vCJD) and human immunodeficiency virus (HIV). It is safest to use lenses that can be discarded after a single trial. For patients requiring conventional soft lenses, an appropriate disposable diagnostic lens can still be used and ordered with alterations in back optic zone radius (BOZR) or total diameter (TD) for the final fit. In the UK, rigid lenses should be disposed of after use for a single patient where possible. Complex rigid lenses that cannot easily be replaced after a single use must be cleaned thoroughly and then soaked in a solution of 2% sodium hypochlorite for 1 hour at room temperature (College of Optometrists guidance). There is no specific advice on cleaning soft trial lenses for reuse; single use is recommended wherever possible. The first RGP lens can be ordered empirically or from topography with an exchange warranty and the final lens parameters adjusted subsequently. Lenses that pose the greatest risk are cosmetic lenses. Plano coloured lenses can be bought at unregistered outlets in many
countries and may fit poorly. Friends often exchange them to try different ‘looks’. Hence, when there is no regulation on their supply, it is difficult to control their use and the potential risk of serious infection.
The Contact Lens Prescription What is it, and what obligations are imposed on the practitioner for releasing such information? In the UK, it is a legal requirement to provide the patient with his or her contact lens prescription once the practitioner judges the lenses to be satisfactory. In the USA, it is mandatory that a contact lens prescription be released immediately after the examination is completed. To release a contact lens prescription, the practitioner must first determine: lens parameters suitable wearing schedules ■ the replacement frequency. ■ ■
The prescription must allow the patient to obtain lenses elsewhere (see below), but it should not be viewed as one-way traffic for so-called consumer rights. However, practitioners must protect themselves from liability arising from incorrect dispensing and product liability. A contact lens prescription should contain the information necessary for the patient to have the prescription properly dispensed and should include the following: name of the lens manufacturer type of lens and mode of wear ■ power ■ BOZR and TD ■ date the prescription was dispensed and its expiry date ■ date of patient’s last examination ■ replacement frequency if applicable ■ clinician’s signature and name (and registration number in the UK). ■ ■
However, only the practitioner can determine when a contact lens fitting is actually completed. Only then can the patient be handed a copy of the lens prescription. Until such a time, there is no obligation to provide the patient with the prescription.
Safeguarding the Practitioner As mentioned earlier, a contact lens prescription should contain information such as the lens manufacturer. Therein lies a problem for online organisations that dispense their own brand or a substitute brand. Practitioners must therefore include in the patient release form (see below) that brand substitution is not appropriate and that this voids the contact lens prescription.
EXPIRY DATE The practitioner must state the expiry date of the prescription, especially if it is for an extended-wear lens. This should be limited to the minimum quantity of supply. For example, PureVision is supplied in 3-month units and hence should be
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given a 3-month expiry date, assuming the practitioner feels that the patient requires it. If a lens is habitually worn for 30 continuous days and the patient purchases a 3-month supply, the practitioner is obliged to review the patient wearing the lenses before the next supply. Hence continuous wear has given the practitioner greater leverage in prescription expiry dates, which therefore provide practitioners with an effective way of safeguarding themselves from non-compliant patients.
WEARING MODALITY The mode of wear must be stated; for example, ‘for daily wear only’. This can be even if the type of lens is an extended-wear silicone hydrogel that has been determined as appropriate for daily wear only for a particular patient. Similarly, although a manufacturer indicates that its lens is suitable for 30-day continuous wear, a particular patient may be suitable only for, say, not greater than 7 days of extended wear. This must be stated unambiguously on the release form that accompanies the contact lens prescription.
THE CONTACT LENS RELEASE FORM This should almost always accompany a contact lens prescription and may form an addendum to the prescription form. The release form should contain information to the effect that if the contact lens prescription is not dispensed according to the specifications, the contact lens prescription is void. The form should contain an obligation on the part of the third-party supplier to assume liability for any complications that may arise (assuming the patient has had an uneventful adaptive trial period with the lenses).
Record Keeping Any starting point for medicolegal negligence litigation is the patient’s records, either computer or hand-written. Practitioners must, for their own protection, maintain a full history of the patient’s trial lenses and prescription lenses. This is imperative to facilitate adequate management of the patient. Records should be legible and comprehensive such that, if another contact lens practitioner were to attend to the patient, he could easily follow the continuum of care, and practitioners should be aware of the legal implications if the records are incomplete. An example of a contact lens prescription and release form available at: https://expertconsult.inkling.com/.
WHAT CONSTITUTES A RECORD CARD? A record card is a subjective and objective collection of information, signs and symptoms pieced together by a listening and observant practitioner about the patient who has, in his or her own words, indicated the reason for the consultation. A full record of the patient’s history, signs and symptoms should be completed at the time, as recollection at a later date would be nearly impossible. The subjective response(s) of the patient must therefore be documented, i.e. why the patient is being seen and what symptoms are reported. The history should include the main complaint, the patient’s ocular history and any past medical history, as
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well as any family ocular and general health history. The examination should include all tests performed with clear and unambiguous results. What is important here is that when grading parts of the eye, clinical grading scales should be used which are consistent, numeric and able to be understood by other colleagues (see Brien Holden Vision Institute (BHVI) grading scale available at: https://expertconsult.inkling.com/ or Efron scale). Most records can be obtained under legal preliminary discovery, pre-trial discovery or under subpoena at hearing or shortly before. Hence the records (unless lost or destroyed) will come to the attention of the prospective plaintiff or the actual plaintiff. Information must be meaningful, sufficient to allow evaluation and determination of key issues such as: Who examined the patient and why? What tests were performed and why? ■ What information was given to the patient about the procedures? ■ Did the patient give consent, informed or passively, to any procedures? ■ ■
RECORD KEEPING AND LITIGATION Cases involving allegations of negligence against health care practitioners use the existence and quality of records as a key issue in the fact-finding process. A patient-plaintiff is likely to remember more about the relevant details than the practitioner as the practitioner sees many similar patients during the course of the day. Hence, unless detailed notes are made, it is likely that the practitioner’s memories of a particular conversation will fade much more quickly than the patient’s. To prove or establish what may have happened a few years earlier, practitioners need to prove a general practice routine with respect to certain consultations; for example, a slit-lamp and topographical examination with resultant trial lens assessment for all new contact lens patients. Records must be contemporaneous with the consultation. The following are examples of successful and unsuccessful ‘compiled’ record notes.
SUCCESSFULLY COMPILED NOTES In Vale v Ho (1997) a patient alleged that his doctor failed to provide the kind of warnings mandated under the terms of Rogers v Whitaker (1992) of the risks involved in undergoing surgery. The defendant doctor was able to base his evidence on exclusive and detailed notes which he swore had been compiled contemporaneously. These notes contradicted much of the patient’s evidence in relation to when and if warnings had been given, including what was said by the doctor to the patient. The judge found for the doctor, as he based it on the contemporaneity of the doctor’s notes and the fact that they had been compiled before any allegations of impropriety had been made by the patient.
INEFFECTIVE NOTES In Locher v Turner (1995) the plaintiff asserted that the doctor had failed unreasonably to investigate adequately the condition
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of the plaintiff’s colon for some 12 months after his initial report of symptoms indicated significant problems with the colon. The doctor’s notes were in short-form style and were somewhat cryptic. In addition, the doctor purported to give evidence in court of her memories of her interaction with the patient, which were additional to what was found in her notes. The Court of Appeal stated that it could not decide the appeal on the basis of the doctor’s verbal evidence which purported to fill in the gaps in her written notes. In Hribar v Wells (1995), where the plaintiff sued her dentist, it was alleged that the dentist failed under the requirements articulated by the High Court in Rogers v Whitaker to properly warn her about the risks of an operation. The trial judge preferred the evidence of the plaintiff to that of the dentist, who had few notes and relied on his ‘invariable practice’ of providing verbal information to the patient prior to surgery. The maintenance of contemporaneously produced, electronically secure, thorough, discreetly compiled records of practitioner–patient interactions is necessary to protect against litigation. It gives the practitioner a clear, convincing and highly probative account of what was done and said in respect of conversations and clinical interventions that may have been unremarkable at the time and may have occurred many years previously. Without such record keeping, litigation can ensue and be contested successfully, regardless of the practitioner’s work and communication with the patient.
Provide leaflets/brochures to back up verbal information and note that these have been issued. See https://expertconsult. inkling.com/ for further information. ■ Refer the patient to another practitioner if it is in the patient’s interest. ■ Note the patient’s consent and understanding of your recommendations. ■ Keep full and adequate records of all advice, tests and trials. ■ Note the patient’s understanding of the advice given and the acceptance or otherwise of your recommendations. ■ Be prepared to issue a prescription for the final contact lens once you are satisfied that the lenses are of optimal fit and power and are safe for the patient. Give all the details relevant to the prescription, as mentioned earlier. ■ Issue a release form with the prescription to ensure that any third party dispensing the lenses does this exactly as prescribed and also accepts liability for the accuracy and safety of any lenses supplied. ■
DISCLAIMER It should be stressed that advice given in this chapter is of a general nature only and may vary from country to country. Practitioners should always seek advice from their own professional body.
LONG-TERM RECORD KEEPING Records need to be kept for several years after a patient has been discharged in case of future litigation. For any person over 14 years old, records must be kept for 10 years, even if the patient has died; for children and young people,for 10 years after they were last seen or until the patient’s 25th birthday, if later (Guide for Professional Practice (2018).
DATA PROTECTION The General Data Protection Regulation (GDPR) came into effect in Europe on 25 May 2018 (see GDPR, 2018) and applies to all individuals and organisations including healthcare organisations. Its aim is to ensure that data is collected and securely stored for an individual and is limited to what is necessary. Information about the patient’s care can be securely passed to other healthcare professionals.
Summary It is well accepted that a practitioner who is perceived by the patient as competent and caring, and who has a good interpersonal relationship with the patient, is less likely to be sued. Nevertheless, prudent action by the practitioner during his time with the patient can significantly reduce the likelihood of future legal action. Ensure that your knowledge is current, comprehensive and adequate to deal with the specific patient. ■ Offer all relevant modalities, even those that may fall outside your own scope of practice. ■ Give detailed explanations of the pros and cons of each modality and the relative risks involved. ■
LEGAL CASES REFERRED TO IN THIS CHAPTER Bolam v Friern Hospital Management Committee (1957) 1 WLR 582 (English case) Canterbury v Spence (1972) 464 F 2d 772 (US case) The re-use of contact lenses and ophthalmic devices. https:// guidance.college-optometrists.org/guidance-contents/ safety-and-quality-domain/infection-control/ the-re-use-of-contact-lenses-and-ophthalmic-devices/ Guide for Professional Practice (2018) College of Optometrists, UK Guide to the General Data Protection Regulation (GDPR), 2018; https://ico.org.uk/for-organisations/guide-to-the -general-data-protection-regulationgdpr/?template=pdf&patch=97#link0 Haughian v Paine (1987) 37 DLR (4th) 624 at 644 (Canadian case) Hribar v Wells, Unreported, Supreme Court, Full Court, SA 8 June 1995 (Australian case) Locher v Turner (1995) QCA 106 (Supreme Court of Queensland – Court of Appeals) Reibl v Hughes (1980) 1 14 D.L.R. (3d) 1 (Canadian Supreme Court) Rogers v Whitaker (1992) 67 ALJR 47 (Australian High Court) Sidaway v Board of Governors of Bethlem Royal Hospital (1985) AC 871 at 887 per Lord Scarman (English case) UN, WHO (2012) - United Nations, World Health Organization International Travel and Health. Chapter 5: Infectious Diseases of Potential Risk for Travellers. (http://www.who. int/ith/ITH2009Chapter5.pdf) Vale v Ho (1997) CA 40331/95 (Supreme Court of New South Wales)
Legal Issues and Contact Lenses MICHAEL MIHAILIDIS
CHAPTER OUTLINES
Negligence, 529 Standard of Care, 529 Failure to Give Advice on Alternative Modalities, 531 Contact Lenses and Transmissible Diseases, 532
This chapter will endeavour to cover the legal aspects of fitting and prescribing contact lenses. To do this, an explanation of the tort of negligence (malpractice) is required with recent precedent case law. This is the basis of most claims that are ‘negligence-based’. Examples of the law in its application are given to emphasise certain contact modalities. It is important for practitioners to understand the process in which litigation ensues; if they can identify with the basic legal requirements and incorporate them into their mode of practice, the claims against them ultimately will be diminished. Contact lenses are medical devices. The contact lens practice issues that fall under the tort of negligence may instigate legal and ethical debate; these issues fall into three categories: 1. the patient: ■ understanding the needs of each individual patient ■ competence in fitting the lenses ■ the determination of the optimal visual correction. 2. the prescription: ■ how the prescription is written ■ its interpretation ■ dispensing by third parties including online, internet sites. 3. record keeping. Lastly, medical records are discussed as the starting point for medicolegal negligence litigation.
Negligence Negligence or malpractice is the term used to describe all possible civil liabilities practitioners can incur as the end result of their professional services. Health professionals may be held liable if their patients suffer harm as a consequence of their health care. There are two areas of law in which practitioners can be held accountable: civil and criminal law. For the purposes of this chapter, we will concentrate on civil law, which encompasses tort law. The area of tort law pertaining to contact lens practice is negligence. An explanation of how negligence is determined is necessary to understand precedent case law. To make a successful claim of negligence, a plaintiff (the patient) must be able to prove that:
The Contact Lens Prescription, 532 Safeguarding the Practitioner, 532 Record Keeping, 533 Summary, 534
The defendant (the practitioner) owed the plaintiff a duty of care that the defendant breached by failing to exercise the necessary level of care. ■ The plaintiff suffered damage that was inadequately met as a result of the defendant’s breach. This cannot be remedied, hence, damage in the form of monetary compensation would be the primary solution. ■
‘Duty’ is defined as ‘an obligation, recognised by law, to avoid conduct fraught with unreasonable risk of danger to others’. On the issue of whether the practitioner (defendant) owed the patient (plaintiff) a duty of care, the plaintiff will need to establish foreseeability of harm and the proximity between plaintiff and defendant. There is thus a duty to ensure that one’s acts do not cause foreseeable harm to another. The foreseeability element will be established if the patient is a member of a class to whom damage was foreseeable. The foreseeability element is only part of establishing the existence of a duty of care. It is also necessary to show that the relationship between the parties had the necessary degree of proximity. A patient has a proximal relationship with a clinician because a patient would quite clearly be someone who would be injured by a failure on the part of the clinician to take reasonable care.
Standard of Care What is it, and why is it applicable to everyday contact lens practice? There has been a flurry of recent precedent law in favour of letting each patient remain an individual and be treated as such. Prior cases emphasised the concept of paternalistic medicine whereby it was assumed that ‘the doctor knew best’. The shift to treating the patient as an autonomous being allows patients to make necessary decisions, provided they have at their disposal all material facts. The standard of care required is one of reasonableness. In determining a breach of duty, did the practitioner act with the level of care that one would expect of a ‘reasonable person’? In the case of Bolam v Friern Hospital Management Committee (1957), the court considered the standard of care for doctors. Under the Bolam test, a practitioner: …would not be negligent if he or she has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art…a man is not negligent 529
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if he is acting in accordance with such a practice, merely because there is a body of opinion who would take a contrary view. This test had the effect of embodying the ‘reasonable man test’ or the ‘reasonable practitioner’. It was an objective test. This principle was approved by the UK House of Lords in respect of diagnosis, treatment and information disclosure. The Bolam test was applied in the case of Sidaway v Board of Governors of Bethlem Royal Hospital (1985) in its consideration of the provision of information. This case involved a plaintiff suffering damage as a result of a spinal operation. The plaintiff alleged failure of the surgeon to fully disclose the risks associated with the operation. The trial judge rejected the plaintiff ’s claim on the basis that, at that time, it had been established that a responsible body of neurosurgeons had agreed that their colleague’s standard of disclosure was acceptable. Under the Bolam test, the professional practices and opinion against which a clinician would be judged must be a ‘responsible body’, much like a ‘peer review committee’, but this need not be a substantial body of practitioners fitting contact lenses. For example, a small group of practitioners who fit keratoconic lenses may be considered ‘super-specialists’ in fitting complex gas permeable lenses; hence, for the purpose of the Bolam test, the defendant’s actions would be judged against the opinion of this group of practitioners rather than against the whole group of practitioners who fit contact lenses generally. However, the Bolam test has been criticised in subsequent cases in the UK, the USA and Australia. In the Sidaway case above, Lord Scarman rejected the Bolam principle in respect of the provision of information stating that: …English law must recognise a duty of the doctor to warn his patients of the risk inherent in the treatment in which he is participating…The critical limitation is that the duty is confined to material risk. The test of materiality is whether in the circumstances of the particular case, the court is satisfied that a reasonable person in the patient’s position would be likely to attach significance to the risk. Likewise, the Canterbury v Spence (1972) case involved a 19-year-old suffering damage as a result of a laminectomy. The judge in that case considered the scope of the disclosure required of the physician. The definition of ‘scope’ was in terms of the patient’s rights to self-determination and therefore propounded the concept that the degree of information depended on the needs of the particular patient and the particular procedure. He said: A risk is thus material when a reasonable person, in what the physician knows or should know to be the patient’s position, would be likely to attach significance to the risk or cluster of risks in deciding whether or not to forgo the proposed therapy. Similarly, in Reibl v Hughes (1980), in which a patient suffered a stroke following a left carotid endarterectomy and where medical evidence estimated the incidence of the complication as 10%, the judge stated: To allow medical evidence to determine what risks are material and, hence should be disclosed and, correlatively, what risks are not material, is to hand over to the medical profession the entire question of the scope of the duty of disclosure, including
the question whether there has been a breach of that duty… What is under consideration here is the patient’s right to know what risks are involved in undergoing or forgoing certain surgery or other treatment. In Australia, the rejection of Bolam came as a result of Rogers v Whitaker (1992), where the High Court considered the case of Maree Whitaker, who had been blind in her right eye since childhood. She had been referred to Dr Rogers, an ophthalmic surgeon, who recommended an operation on her damaged eye to prevent the possible development of glaucoma. The surgery was claimed to be likely to improve the vision in her damaged eye and also to improve its cosmetic appearance. Postoperatively, she developed sympathetic ophthalmia – a rare condition with an incidence of about 1 in 17,000. The result was a loss of sight in her left eye and almost complete blindness. The plaintiff sued for negligence, alleging that Dr Rogers had failed to warn her of the risk. She claimed that, had she been warned of this possibility, she would never have consented to the surgery. The High Court approached the task of the content of duty and its scope in these matters of ‘failure to warn’. In defining the factors involved in a doctor’s duty to warn, the High Court repeated: A doctor has a duty to warn a patient of a material risk inherent in the proposed treatment. A risk is material if, in the circumstances of the particular case, a reasonable person in the patient’s position, if warned of the risk, would likely attach significance to it or if the medical practitioner is or should reasonably be aware that the particular patient, if warned of the risk, would be likely to attach significance to it. The evolution from Bolam to Rogers was gradual, and the courts came to hold the professions more accountable for adverse events arising out of their activities. In Rogers, the High Court – in discussing ‘material’ risk – held that the subjective text was the model most appropriate when it stated: ‘a particular patient, if warned of the risk would find it of significance’. Medical ethicists have since endorsed this patient-orientated approach. They see the consent process as a change from a single event of paternalistic beneficence to an integrated process of information sharing and informed decision making. This standard is now a consent, based on an autonomous patient making an informed decision based on understanding. Although the practitioner may in depth and comprehensively impart information, there is no guarantee that patients will understand all they have been told. Patients may also be presented with hard copy data in the form of information sheets, but the problem is that they may be too exhaustive and become incomprehensible. However, it is suggested that the provision of detailed brochures, as well as specific and detailed consent forms, is the minimum required in informing a group of patients for, say, an orthokeratology procedure. Patients may have unrealistic expectations of the result they would like to achieve and may be resistant to modifications or perceived compromises pre-discussed. On the other hand, the practitioner may be unreasonably optimistic in the portrayal of the outcomes. Many patients seeking to wear contact lenses are unrealistic in their appreciation of the visual outcome. Likewise, a full appreciation of worst case scenarios should almost always be depicted to the patient, as visual loss is the
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common denominator and generally why we look after these patients in preventative practice. Since Rogers v Whitaker, cases of medical negligence have come to include allegations of ‘failure to warn’, almost always as a part of a claim. The application of this negligence metamorphosis is not confined to contact lens practice but to all aspects of patient care. In this change in determining standard of care, we can see how Rogers v Whitaker (at least in Australia but similarly in most other countries) can influence all duty of care situations.
Failure to Give Advice on Alternative Modalities Current legal thinking emphasises the critical role of patient autonomy in health care decision-making. This emphasis extends as far as creating an obligation for the practitioner to advise a patient about complementary and alternative visual corrections such as contact lenses. The law imposes on the practitioner a duty to exercise reasonable care and skill, not only in examination, diagnosis and treatment but also in the provision of professional information and advice, being a ‘single comprehensive duty’. It is the patient who must make the decision, but it is the clinician who holds the information on which the decision must be made. In Haughian v Paine (1987), it was ruled that ‘one cannot make an informed decision to undertake a risk without knowing the alternatives to undergoing the risk’. The area pertinent to the practitioner is the use of contact lenses as therapeutic devices rather than for simple cosmesis. Consider the supply of spectacles to a moderate or severe keratoconic patient. In this case the practitioner may be considered negligent if he has not provided the optimal visual correction (contact lenses). The same would apply to an aphake or corneal graft recipient. Nevertheless this should be qualified by careful explanation about the trial of contact lenses, their effect, associated risks, complications of fitting, costs, time involved, etc. These must all be conveyed in such a way that patients have all the facts at their disposal. Should they opt not to undergo any form of contact lens fitting, that is their decision, but the practitioner has at least satisfied the minimum legal requirements under Rogers v Whitaker. It is incumbent on the practitioner to do whatever is necessary for the patient’s ocular well-being. Practitioners have a duty to investigate what needs to be prescribed and may also need to refer to someone more competent if their skill in a particular area is limited. Keratoconus is a classic example where special expertise and advice are required. Practitioners should not assume that contact lens correction is automatically essential and should consider whether corneal cross-linking would be of benefit instead of contact lenses. Alternatively, if the visual acuity is reasonable with spectacles, the patient may be happy to wear this correction, and exposing the patient to the potential complications of contact lenses could leave the practitioner at risk. Similarly, if patients are unable to attend for regular aftercare, potential ocular damage could result, so again contact lenses should not be advised. How much information should be given and should a lens trial be conducted so that the patient fully understands what to expect? The patient must be given a realistic idea of what to expect when wearing rigid lenses, the risks involved and
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also an understanding of the variation in such factors as individual corneal sensitivity in determining success or failure. As mentioned earlier, practitioners must be pragmatic with their patient’s understanding of the limits of treatment. Equally, they must not allow themselves to become so enthusiastic about correcting the person’s vision that the end result is a disappointed patient whose expectations are not met. The contact lens fitting philosophy used could possibly influence future corneal scarring. Should RGP lenses be fitted with apical clearance or apical touch, for example? What is important here is that whichever technique is used, the practitioner must adhere to and become clinically competent at fitting the chosen philosophy. Under the Bolam principle, the practitioner would not be required to explain the type of fitting design or the possibility of scarring as this would be considered clinically acceptable by an expert group of ‘sub-specialists’. If we apply Rogers v Whitaker, the practitioner must explain possible and probable visual outcomes as well as the possibility of corneal scarring. Scarring would be considered a material risk in undergoing a keratoconic fitting, especially if, as mentioned earlier, the patient had reasonable vision with spectacles. These examples are for therapeutic purposes; what of the situation where a person wears contact lenses for cosmetic reasons only? Is there a duty to at least advise of alternative lenses such as daily wear silicone hydrogels (compared with conventional hydrogels), or does the practitioner say nothing? This situation would be harder to contest by a plaintiff patient, as the long-term implications have not been quantified significantly to measure possible future harm or damage to the patient.
WHAT LENSES SHOULD A PRACTITIONER PRESCRIBE? When should a rigid gas permeable (RGP) or scleral lens be fitted as opposed to a soft lens? The reasons vary as to the person’s prescription, age and occupation. Take an example of a 6-year-old child whose prescription is: R +9.00/−4.00 × 175 L +8.75/−5.75 × 180 They may attain ‘adequate’ aided acuities with each eye with a toric soft lens, but the underlying ocular integrity and ‘legal’ basis for prescribing a soft contact lens is not always the optimal standard required by a practitioner. For the following reasons, it may be in the best interests of the patient to prescribe a rigid lens: He/she may see better out of a rigid lens. Stability may be better with a rigid lens. ■ Rigid lenses may be easier to insert. ■ Vision may be better with a rigid lens which may reduce possible amblyopic issues. ■ Prescribing a soft toric lens for the patient above may compromise the acuity. More importantly, do the parents know that their child might achieve a ‘better’ aided acuity? Has the groundwork been laid in explaining the pros and cons of both types of lenses? ■ ■
What do you do with a patient with a recent corneal transplant with the sutures still in place? The patient relies on vision for work.
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If you prescribe a soft lens, the lens will come into contact with the sutures, causing possible neovascularisation and graft rejection. ■ If you prescribe a standard RGP lens, the lens may not fit adequately and may cause similar problems. ■ A scleral lens (fitted properly) will not come into contact with the sutures and can achieve a good outcome. However, there is still a physiological risk. ■
The patient needs to be carefully informed and to understand the advantages, disadvantages and risks of each lens type. In other situations there may be only one type of lens that is considered suitable, and this must be explained to the patient together with the reasons. In specific areas, such as myopia control and multifocal lenses, warnings should be given that there is no guarantee of achieving total success. In these more complex cases the general advice therefore is to do the following: Present all the alternative choices to the patient. ■ Explain the advantages, disadvantages and risks of each option. ■ Always try a spectacle correction first if it will give an acceptable result. ■ If you consider that there is only one option, then explain your reasoning. ■ Explain the need for regular monitoring. ■ Refer to a colleague if the condition is not in your area of expertise. ■
The results may not be what was intended or designed, and these messages conveyed and understood by the patient go a long way in preventing a foreseeable injury caused by your treatment.
Contact Lenses and Transmissible Diseases In an era when it is understood that diseases may be transmitted by fluids, practitioners should be cautious for themselves, their patients and the actions of their patients. Diseases that can readily be transmitted by fluid should always be considered when fitting contact lenses (see UN, WHO (2012); and also Chapter 4). These include new variant Creutzfeldt–Jakob disease (vCJD) and human immunodeficiency virus (HIV). It is safest to use lenses that can be discarded after a single trial. For patients requiring conventional soft lenses, an appropriate disposable diagnostic lens can still be used and ordered with alterations in back optic zone radius (BOZR) or total diameter (TD) for the final fit. In the UK, rigid lenses should be disposed of after use for a single patient where possible. Complex rigid lenses that cannot easily be replaced after a single use must be cleaned thoroughly and then soaked in a solution of 2% sodium hypochlorite for 1 hour at room temperature (College of Optometrists guidance). There is no specific advice on cleaning soft trial lenses for reuse; single use is recommended wherever possible. The first RGP lens can be ordered empirically or from topography with an exchange warranty and the final lens parameters adjusted subsequently. Lenses that pose the greatest risk are cosmetic lenses. Plano coloured lenses can be bought at unregistered outlets in many
countries and may fit poorly. Friends often exchange them to try different ‘looks’. Hence, when there is no regulation on their supply, it is difficult to control their use and the potential risk of serious infection.
The Contact Lens Prescription What is it, and what obligations are imposed on the practitioner for releasing such information? In the UK, it is a legal requirement to provide the patient with his or her contact lens prescription once the practitioner judges the lenses to be satisfactory. In the USA, it is mandatory that a contact lens prescription be released immediately after the examination is completed. To release a contact lens prescription, the practitioner must first determine: lens parameters suitable wearing schedules ■ the replacement frequency. ■ ■
The prescription must allow the patient to obtain lenses elsewhere (see below), but it should not be viewed as one-way traffic for so-called consumer rights. However, practitioners must protect themselves from liability arising from incorrect dispensing and product liability. A contact lens prescription should contain the information necessary for the patient to have the prescription properly dispensed and should include the following: name of the lens manufacturer type of lens and mode of wear ■ power ■ BOZR and TD ■ date the prescription was dispensed and its expiry date ■ date of patient’s last examination ■ replacement frequency if applicable ■ clinician’s signature and name (and registration number in the UK). ■ ■
However, only the practitioner can determine when a contact lens fitting is actually completed. Only then can the patient be handed a copy of the lens prescription. Until such a time, there is no obligation to provide the patient with the prescription.
Safeguarding the Practitioner As mentioned earlier, a contact lens prescription should contain information such as the lens manufacturer. Therein lies a problem for online organisations that dispense their own brand or a substitute brand. Practitioners must therefore include in the patient release form (see below) that brand substitution is not appropriate and that this voids the contact lens prescription.
EXPIRY DATE The practitioner must state the expiry date of the prescription, especially if it is for an extended-wear lens. This should be limited to the minimum quantity of supply. For example, PureVision is supplied in 3-month units and hence should be
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given a 3-month expiry date, assuming the practitioner feels that the patient requires it. If a lens is habitually worn for 30 continuous days and the patient purchases a 3-month supply, the practitioner is obliged to review the patient wearing the lenses before the next supply. Hence continuous wear has given the practitioner greater leverage in prescription expiry dates, which therefore provide practitioners with an effective way of safeguarding themselves from non-compliant patients.
WEARING MODALITY The mode of wear must be stated; for example, ‘for daily wear only’. This can be even if the type of lens is an extended-wear silicone hydrogel that has been determined as appropriate for daily wear only for a particular patient. Similarly, although a manufacturer indicates that its lens is suitable for 30-day continuous wear, a particular patient may be suitable only for, say, not greater than 7 days of extended wear. This must be stated unambiguously on the release form that accompanies the contact lens prescription.
THE CONTACT LENS RELEASE FORM This should almost always accompany a contact lens prescription and may form an addendum to the prescription form. The release form should contain information to the effect that if the contact lens prescription is not dispensed according to the specifications, the contact lens prescription is void. The form should contain an obligation on the part of the third-party supplier to assume liability for any complications that may arise (assuming the patient has had an uneventful adaptive trial period with the lenses).
Record Keeping Any starting point for medicolegal negligence litigation is the patient’s records, either computer or hand-written. Practitioners must, for their own protection, maintain a full history of the patient’s trial lenses and prescription lenses. This is imperative to facilitate adequate management of the patient. Records should be legible and comprehensive such that, if another contact lens practitioner were to attend to the patient, he could easily follow the continuum of care, and practitioners should be aware of the legal implications if the records are incomplete. An example of a contact lens prescription and release form available at: https://expertconsult.inkling.com/.
WHAT CONSTITUTES A RECORD CARD? A record card is a subjective and objective collection of information, signs and symptoms pieced together by a listening and observant practitioner about the patient who has, in his or her own words, indicated the reason for the consultation. A full record of the patient’s history, signs and symptoms should be completed at the time, as recollection at a later date would be nearly impossible. The subjective response(s) of the patient must therefore be documented, i.e. why the patient is being seen and what symptoms are reported. The history should include the main complaint, the patient’s ocular history and any past medical history, as
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well as any family ocular and general health history. The examination should include all tests performed with clear and unambiguous results. What is important here is that when grading parts of the eye, clinical grading scales should be used which are consistent, numeric and able to be understood by other colleagues (see Brien Holden Vision Institute (BHVI) grading scale available at: https://expertconsult.inkling.com/ or Efron scale). Most records can be obtained under legal preliminary discovery, pre-trial discovery or under subpoena at hearing or shortly before. Hence the records (unless lost or destroyed) will come to the attention of the prospective plaintiff or the actual plaintiff. Information must be meaningful, sufficient to allow evaluation and determination of key issues such as: Who examined the patient and why? What tests were performed and why? ■ What information was given to the patient about the procedures? ■ Did the patient give consent, informed or passively, to any procedures? ■ ■
RECORD KEEPING AND LITIGATION Cases involving allegations of negligence against health care practitioners use the existence and quality of records as a key issue in the fact-finding process. A patient-plaintiff is likely to remember more about the relevant details than the practitioner as the practitioner sees many similar patients during the course of the day. Hence, unless detailed notes are made, it is likely that the practitioner’s memories of a particular conversation will fade much more quickly than the patient’s. To prove or establish what may have happened a few years earlier, practitioners need to prove a general practice routine with respect to certain consultations; for example, a slit-lamp and topographical examination with resultant trial lens assessment for all new contact lens patients. Records must be contemporaneous with the consultation. The following are examples of successful and unsuccessful ‘compiled’ record notes.
SUCCESSFULLY COMPILED NOTES In Vale v Ho (1997) a patient alleged that his doctor failed to provide the kind of warnings mandated under the terms of Rogers v Whitaker (1992) of the risks involved in undergoing surgery. The defendant doctor was able to base his evidence on exclusive and detailed notes which he swore had been compiled contemporaneously. These notes contradicted much of the patient’s evidence in relation to when and if warnings had been given, including what was said by the doctor to the patient. The judge found for the doctor, as he based it on the contemporaneity of the doctor’s notes and the fact that they had been compiled before any allegations of impropriety had been made by the patient.
INEFFECTIVE NOTES In Locher v Turner (1995) the plaintiff asserted that the doctor had failed unreasonably to investigate adequately the condition
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of the plaintiff’s colon for some 12 months after his initial report of symptoms indicated significant problems with the colon. The doctor’s notes were in short-form style and were somewhat cryptic. In addition, the doctor purported to give evidence in court of her memories of her interaction with the patient, which were additional to what was found in her notes. The Court of Appeal stated that it could not decide the appeal on the basis of the doctor’s verbal evidence which purported to fill in the gaps in her written notes. In Hribar v Wells (1995), where the plaintiff sued her dentist, it was alleged that the dentist failed under the requirements articulated by the High Court in Rogers v Whitaker to properly warn her about the risks of an operation. The trial judge preferred the evidence of the plaintiff to that of the dentist, who had few notes and relied on his ‘invariable practice’ of providing verbal information to the patient prior to surgery. The maintenance of contemporaneously produced, electronically secure, thorough, discreetly compiled records of practitioner–patient interactions is necessary to protect against litigation. It gives the practitioner a clear, convincing and highly probative account of what was done and said in respect of conversations and clinical interventions that may have been unremarkable at the time and may have occurred many years previously. Without such record keeping, litigation can ensue and be contested successfully, regardless of the practitioner’s work and communication with the patient.
Provide leaflets/brochures to back up verbal information and note that these have been issued. See https://expertconsult. inkling.com/ for further information. ■ Refer the patient to another practitioner if it is in the patient’s interest. ■ Note the patient’s consent and understanding of your recommendations. ■ Keep full and adequate records of all advice, tests and trials. ■ Note the patient’s understanding of the advice given and the acceptance or otherwise of your recommendations. ■ Be prepared to issue a prescription for the final contact lens once you are satisfied that the lenses are of optimal fit and power and are safe for the patient. Give all the details relevant to the prescription, as mentioned earlier. ■ Issue a release form with the prescription to ensure that any third party dispensing the lenses does this exactly as prescribed and also accepts liability for the accuracy and safety of any lenses supplied. ■
DISCLAIMER It should be stressed that advice given in this chapter is of a general nature only and may vary from country to country. Practitioners should always seek advice from their own professional body.
LONG-TERM RECORD KEEPING Records need to be kept for several years after a patient has been discharged in case of future litigation. For any person over 14 years old, records must be kept for 10 years, even if the patient has died; for children and young people,for 10 years after they were last seen or until the patient’s 25th birthday, if later (Guide for Professional Practice (2018).
DATA PROTECTION The General Data Protection Regulation (GDPR) came into effect in Europe on 25 May 2018 (see GDPR, 2018) and applies to all individuals and organisations including healthcare organisations. Its aim is to ensure that data is collected and securely stored for an individual and is limited to what is necessary. Information about the patient’s care can be securely passed to other healthcare professionals.
Summary It is well accepted that a practitioner who is perceived by the patient as competent and caring, and who has a good interpersonal relationship with the patient, is less likely to be sued. Nevertheless, prudent action by the practitioner during his time with the patient can significantly reduce the likelihood of future legal action. Ensure that your knowledge is current, comprehensive and adequate to deal with the specific patient. ■ Offer all relevant modalities, even those that may fall outside your own scope of practice. ■ Give detailed explanations of the pros and cons of each modality and the relative risks involved. ■
LEGAL CASES REFERRED TO IN THIS CHAPTER Bolam v Friern Hospital Management Committee (1957) 1 WLR 582 (English case) Canterbury v Spence (1972) 464 F 2d 772 (US case) The re-use of contact lenses and ophthalmic devices. https:// guidance.college-optometrists.org/guidance-contents/ safety-and-quality-domain/infection-control/ the-re-use-of-contact-lenses-and-ophthalmic-devices/ Guide for Professional Practice (2018) College of Optometrists, UK Guide to the General Data Protection Regulation (GDPR), 2018; https://ico.org.uk/for-organisations/guide-to-the -general-data-protection-regulationgdpr/?template=pdf&patch=97#link0 Haughian v Paine (1987) 37 DLR (4th) 624 at 644 (Canadian case) Hribar v Wells, Unreported, Supreme Court, Full Court, SA 8 June 1995 (Australian case) Locher v Turner (1995) QCA 106 (Supreme Court of Queensland – Court of Appeals) Reibl v Hughes (1980) 1 14 D.L.R. (3d) 1 (Canadian Supreme Court) Rogers v Whitaker (1992) 67 ALJR 47 (Australian High Court) Sidaway v Board of Governors of Bethlem Royal Hospital (1985) AC 871 at 887 per Lord Scarman (English case) UN, WHO (2012) - United Nations, World Health Organization International Travel and Health. Chapter 5: Infectious Diseases of Potential Risk for Travellers. (http://www.who. int/ith/ITH2009Chapter5.pdf) Vale v Ho (1997) CA 40331/95 (Supreme Court of New South Wales)