THE WELLINGTON EYE CLINIC WHOLLY SUPPORTS THE PROPOSED STANDARDS FOR LASER REFRACTIVE SURGERY FOR IRELAND.

Standards for LASER REFRACTIVE SURGERY

Surgeons carrying out refractive procedures

a) Surgeons must be registered with the IMC

b) Surgeons should preferably be on the Specialist Register e.g. hold a certificate of Higher Specialist Training or an equivalent qualification. Registering on the Specialist register is presently a voluntary act in Ireland and therefore any ophthalmologist who would be eligible for a consultant’s post in Ireland would also meet the criteria.

c) Surgeons need to have undergone appropriate training for refractive surgery after completing their specialist ophthalmology training. This may take the form of a fellowship with a recognised refractive surgeon or completing training courses in refractive surgery.

d) Surgeons must always recognise and work within the limits of their professional competence.

e) All surgeons undertaking refractive surgery must keep a folder for the purposes of revalidation. This will include documentation of on-going education in refractive surgery techniques and skills and audits of refractive surgery procedures.

f) Surgeons performing refractive procedures must keep their knowledge and skills up to date and should regularly take part in educational activities. Surgeons where possible should belong to a relevant professional organisation which provides Continuing Professional Development and adheres to the principles of good medical practice, for example:

• The Royal College of Ophthalmologists or
• One of the Royal Colleges of Surgeons in the United Kingdom or Ireland.

Surgeons should in addition consider becoming members of other relevant associations for the purposes of Continuing Medical Education (CME). Examples include:

• British Society for Refractive Surgery (BSRS)
• United Kingdom and Ireland Society of Cataract and Refractive Surgeons (UKISCRS)
• International Society of Refractive Surgeons (ISRS)
• European Society of Cataract and Refractive Surgeons (ESCRS)
• Medical Contact Lens and Ocular Surface Association (MCLOSA)
• American Society of Cataract and Refractive Surgery (ASCRS)

g) Surgeons must be members of a medical defence organisation or maintain professional indemnity insurance.

Facilities

a) There must be strict adherence to protocols provided by manufacturers of equipment for their maintenance and calibration.

b) There must be dated and documented procedures within the facility for the use of all clinical equipment. These must be reviewed annually.

c) All staff using equipment must have completed training in the safe clinical use of the equipment and have demonstrated and documented competence to person(s) appointed by the Medical Advisory Committee, or an equivalent management group.

d) There must be facilities available for patients to have confidential discussions with clinical staff in conditions of visual and auditory privacy.

e) Staff identification badges must include both name and status. Consultant’s names need to appear on either the door to the consulting room or the desk or both.

f) A backup power supply must be available in case of power failure during a procedure.

Information for patients
a) Information for patients should be written in concise, plain non-technical language.
b) Published information for patients should include:

• The range of refractive surgery procedures stating which ones are available at the facility
• Eligibility criteria for patients
• Treatment options including relative advantages and disadvantages
• General and procedure-specific risks and complications associated with surgery, their frequency, management course and possible outcome
• Statistical information regarding the probability of achieving the desired goal or probability of needing more than one procedure

c) Information for patients should include the following details about the operating surgeon:

• Qualifications

d) Patients should be informed that bilateral same day surgery carries implications in the rare event of serious bilateral complications. This risk is reduced by treating the two eyes as separate procedures (e.g. different blades, keratomes, instruments, fluids) in order to reduce the risk of cross contamination. On the other hand, the majority of patients prefer the convenience of bilateral simultaneous surgery. Once the advantages and disadvantages of each method have been explained to the patient, the choice remains with the patient. It is important that the patient feel comfortable with the decision that they make.

It is imperative that bilateral simultaneous surgery be practised according to the most stringent criteria (e.g. separate instrument set for the 2 eyes, one blade per procedure, strict aseptic techniques)

e) Information for patients should include a price list of procedures and should be explicit about what is and is not included in the quoted fees. It should also give details about payments of deposits, their refund, and any penalty which may be incurred by cancellation.

f) Written post-operative instructions should be given to patients to take home after the procedure/operation. They should include a contact number for the hospital/clinic and a 24 hour emergency number.

g) The following information must be recorded in the notes and a copy given to the patient:

• Pre-operative keratometry
• Pre-operative refraction

The Consent Process

a) The consent process should follow GMC and Department of Health guidelines (Good Medical Practice, May 2001) (or the Irish equivalent)

b) The information document must be given to the patient at least 24 hours before the procedure is undertaken. It is essential that time is allowed for the patient to take in the information and discuss the risks and benefits of the procedure before it is undertaken.

c) The person performing the preoperative assessment must ascertain from the patient if there are any questions arising from information given and recap the treatment expectations, potential risks and alternative treatments before confirming that the patient fully understands the written and discussion material.

d) All patients should have an appointment with the surgeon who will be carrying out the procedure. This consultation should exclude unsuitable patients at an early stage

e) No patient should have the procedure carried out sooner than 24 hours after the initial consultation with the surgeon.

f) The consent form must be signed in the presence of the surgeon, or other suitably qualified and trained professional.

g) The consent form must reference the Information given to the patient and state:

• The elective nature of the procedures
• That glasses or contact lenses may still be required after surgery
• That pain or discomfort may occur
• Any specific increased risks pertaining to the individual patient in question

h) The consent form should contain a section for the surgeon to certify that in his/her professional opinion the patient has fully understood all material risks pertaining to the individual patient in question.

Clinical Governance

a) Surgeons must be personally responsible for patient care.

b) Surgeons must maintain an outpatient service, either at the clinic / hospital where refractive surgery is undertaken, or elsewhere, such that the practitioner can assess the patient's appropriateness for refractive surgery and provide appropriate follow-up care.

c) Surgeons must ensure their availability for emergencies or pre-arrange appropriate cover if on leave.

d) Incentives should not be offered to optometrists, dispensing opticians or other professionals in return for the referral of patients for refractive surgery.

e) Clinical staff must have documented on-going education in refractive surgery techniques and skills.

f) Surgeons' quality indicators, from all types of refractive procedures undertaken, must be reviewed at regular intervals as part of the hospital's /clinic's clinical audit programme. Adverse variances should be reported to the Medical Advisory Committee or Irish equivalent.

g) All clinical incidents, errors and near misses must be recorded, investigated and collated,

h) Reports on clinical incidents should be discussed regularly at the Medical Advisory Committee, or an equivalent clinical management group for the hospital/clinic. This may be part of a wider clinical quality/clinical audit report. Information relating to individual surgeons should be passed to them so that it can be included in their revalidation folders,

i) There should be documented integrated care pathways/clinical guidelines in use for common refractive surgery procedures,

j) Clinical guidelines, care pathways should be agreed with staff and be made known to all staff working in the service area,

k) The clinical guidelines /care pathways should cover the range of common variances from the care pathway.

l) All persons making entries into the care pathway notes should sign or initial and date in at least one place on the pathway documentation for each patient An entry should be made on each occasion that the patient is seen or contacted,

m) Clinical support staff (e.g. Optometrists, Registered Nurses) delegated to carry out procedures on behalf of a doctor should be trained and competent in the techniques,

n) All surgeons and other clinical staff engaged in exposure-prone work must preferably have up to date immunisation against Hepatitis B.

Advertising and marketing

a) All advertising must adhere to ASA standards, the BMA Guidelines for advertising and the GMC guidance on advertising. It must be legal, factual and not misleading.

b) Marketing materials must be drafted and designed to safeguard patients from unrealistic expectations of refractive surgery procedures.

c) Advertisements should not offer discounts linked to a deadline date for booking appointments or surgery, or other date-linked incentives.

d) Promotional events such as open evenings should not include financial incentives for potential patients to book a consultation appointment at the event.

e) All staff and speakers at promotional events should be clearly identified with regard to their profession and role within the organisation.

Post-operative evaluation

a) The surgeon should either undertake, or be available to evaluate the patient for the first post-operative visit.

b) It is the responsibility of the surgeon to ensure that the postoperative management is carried out appropriately)

c) Surgeons are expected to be fully trained and well versed in the management of the complications of refractive surgery.

d) Surgeons operating in clinics lacking microbiological or other specialised testing should have prearranged established links to providers offering these services should the need arise.

e) A surgeon without inpatient admitting rights should have a prearranged agreement with an appropriate Consultant Ophthalmologist to provide this service should the need arise.

References:

• Royal College of Ophthalmologists

STANDARD FOR LASER REFRACTIVE SURGERY

WORKING GROUP MEMBERS

a) Wellington Eye Clinic
Arthur Cummings, Richard Corkin

b) Mater Private Hospital
Michael O’Keefe, Susan Fitzsimons

c) Blackrock Clinic
Billy Power, Louis Collum

d) Terenure Laser Centre
Tony Benedict-Smith

e) All Clear Clinic, Belfast
Gerry Kervic, Brendan