Royal College of Ophthalmologists Guidelines

Guidance for Clinical Governance in Ophthalmology

1. Introduction

1.1 Since its foundation The Royal College of Ophthalmologists has taken an active role in promoting high standards of clinical practice. Indeed the College Royal Charter includes the statement that one of the "objects for which the College is incorporated shall be to ..... maintain proper standards in the practice of ophthalmology for the benefit of the public".

1.2 Although the NHS Trust Chief Executives carry ultimate responsibility for the quality of service provided by individual NHS trusts, input from the College is of crucial importance in systems of clinical governance in ophthalmology. These include advice on the appropriate clinical quality standards as well as assisting trusts in both monitoring and improving standards.

1.3 The College recognises that it cannot do this in isolation and that bodies such as the Academy of Medical Royal Colleges, the General Medical Council, the NHS Executive and NHS trusts all have their roles. Other statutory bodies such as the National Institute for Clinical Excellence (NICE), the Commission for Health Improvement (CHI) in England and Wales, and the Clinical Resource and Audit Group (CRAG) and the National Clinical Standards Board (NCSB) in Scotland and the relevant bodies in Northern Ireland, will be crucially important. Clinical governance depends not only on self regulation by clinicians but also requires support for clinicians from managers and involvement of clinicians in management.

1.4 Much of the detail set out in this document should be regarded not as a definitive statement about quality issues but as a starting point for a continuous programme of quality development. Thus it should be possible to obtain more accurate measurement of clinical outcomes as better information gathering systems are put into place or offer alternative advice on, for example, service frameworks when new evidence becomes available.

1.5 Additional funding will be required to install and operate the information technology systems required to facilitate clinical governance. The financial implications for the NHS of improving quality are potentially huge, not least because improvements in outcome for certain surgical procedures may lead to increased demand as has already been seen in modern cataract surgery in recent years.

1.6 The College recognises that the issue of clinical governance is as important in the independent sector as in the NHS. Whilst some of the processes are applicable to both sectors, there are significant differences which may require a different approach. it is however expected that proposals for the independent sector will be similar to those introduced for the NHS.

1.7 Annual reports on clinical quality should be prepared for each ophthalmology unit within NHS trusts. These should cover the items specified in the College Quality Development Programme set out in this document. These reports will inform the trust management and will furnish information for periodic College visits.

1.8 This guidance for ophthalmology units outlines arrangements specific to ophthalmology. Guidelines already published by The Royal College of Ophthalmologists are listed at the end of this document. There are also generic quality issues such as the quality and availability of clinical notes which will apply to all specialties.

1.9 The government's own proposals for implementing clinical governance, published in 1998, in several white papers - (see References), require all NHS organisations to put in place mechanisms to monitor, evaluate and improve quality.

1.10 The General Medical Council has produced a number of publications which set out the standards expected of all doctors, including ophthalmologists. These are included in the list of references at the end of this document, but the duties and responsibilities listed in Good Medical Practice are particularly relevant.

2. Setting the National Quality Standards

2.1 Facilities

The College believes that it is becoming increasingly difficult to deliver the high standards of patient care demanded in a modern service if the facilities provided to deliver that care are inadequate. It recognises that clinical outcome indicators may reflect the provision of facilities and services as much as that of the performance by an individual clinician or trust.

2.1.1 Outpatients

Eye departments differ from those of other acute specialties in that a very high proportion of their work is carried out in outpatient departments. This is because the outpatient workload includes not only elective referrals from general practitioners but also a large primary care component and the work generated as a result of the high volumes of day case surgery. The majority of patients are elderly or are children, and are usually accompanied y relatives or friends.

A variety of specialist investigations and treatments including photography, fluorescein angiography, perimetry, B scan ultrasound, optometric services, orthoptics, anterior and posterior segment laser treatment, minor operations, and pre-surgical assessments are all undertaken as outpatient procedures. These factors mean that special consideration must be given to the staffing and layout of eye outpatient departments. The following requirements are generic to all departments. larger units with subspecialty units, or units with a commitment to undergraduate or postgraduate teaching, will have facilities and levels of equipment more comprehensive than those described below.

i. The environment must be designed with the requirements of the particular patient groups and visually impaired in mind. There should be clear signposting and all patient areas adequately sized to avoid obstacles to patient circulation whether in or out of wheelchairs.

ii. Waiting areas must be well lit and well ventilated and should provide sufficient seating for both patients and accompanying persons. Waiting areas for children should be separate with a play area.

iii. Consulting rooms (or partitioned cubicles) should be dedicated for ophthalmic care and must include a standard test chart, a trial lens set, a slit lamp and tonometer, a binocular indirect ophthalmoscope and condensing lenses for fundoscopy. It should also be possible to examine the supine patient on a couch or reclining chair.

iv. Other necessary equipment for common usage should include contact lenses for gonioscopy and fundus examination, focimeter, static threshold perimeter, and biometry equipment.

v. A minor operations facility should be provided.

vi. Orthoptic examination rooms should be at least 6 metres in length and be appropriately equipped in order to facilitate orthoptic and visual acuity testing in children. Available dissociation tests should include a Hess chart or Lees screen.

vii. Photographic services must be available so that fundus photography and fluorescein angiography can be carried out urgently if indicated.

viii. B scan ultrasonography should also be available although in some hospitals this instrument may be housed in a separate radiology/imaging department.

ix. YAG and posterior segment laser facilities should be available and meet the current safety requirements. It should be possible to use the posterior segment laser without the blue wavelengths.

x. The workload of all doctors in an outpatient department should be such as to allow sufficient time for consultation by each patient whilst ensuring that the waiting time to see the doctor is acceptable. In a general ophthalmic clinic an average of 15 minutes should be allocated for each patient. It is inevitable that emergencies and urgent cases and ward referrals also need to be seen and space should be left in the booking plan to allow for this. It is reasonable for a consultant to see five or six new and six or seven return patients who require further expert opinion. The total number of patients seen by each doctor should not exceed 15 per clinic. Nearly all consultants have a commitment to training junior staff and many also teach medical students in outpatient clinics. This must be taken into account when planning clinic schedules.

xi. Adequate administrative, secretarial, and clerical support should be provided for medical and non-medical staff involved in patient care. In particular, the support services should ensure that the case notes are available.

2.1.2 Inpatients

In those units where ophthalmic patients require admission to hospital for treatment, the following points should be taken into consideration.

i. Whether inpatients are housed in an ophthalmic ward or in dedicated ophthalmic beds in a mixed specialty ward, will be determined by the number of patients and turnover rate. in either situation it is essential that eye patients are looked after by nurses who have been trained for, and have experience of, ophthalmic care.

ii. There must be an appropriately equipped examination room on the ward. If retinal surgery is routinely undertaken there should be a couch or reclining chair in the examination room and an indirect ophthalmoscope.

iii. Children should be admitted to wards where they are attended by staff trained in paediatric and ophthalmic care and where there is access to a consultant paediatrician.

2.1.3 Theatres

i. Ophthalmic operations should take place in operating theatre(s) dedicated to ophthalmic surgery, although there can be no absolute restrictions on other types of surgery being undertaken provided that the risks of cross infection are eliminated. The theatres should not therefore be shared with specialties which commonly operate on infected patients.

ii. Equipment must include an operating microscope with coaxial illumination and binocular assistant's eyepieces that afford the same view as that of the surgeon. A phakoemulsifier and instrumentation for vitreous surgery (even if no elective vitreoretinal surgery is undertaken) are essential. Other equipment will depend on the surgeons' specialties.

iv. The information technology systems handling theatre data should be capable of accurately recording information about the ophthalmic procedure carried out as well as details of the surgeon and the patient (including diagnosis and comorbidity).

v. Anaesthetic facilities for adults and children should conform to the criteria set out in the relevant College guidelines.

2.1.4 Day Case Facilities

i. All ophthalmic patients should have access to day surgery, preferably through a purpose built day case unit, although in many hospitals it is recognised that patients are admitted to wards with day case facilities. The special needs of children should be taken into account.

ii. There must be provision for the general and ophthalmological pre-operative assessment of patients.

iii. Day case ophthalmic theatres should operate to the same quality standards already identified under 2.1.3.

iv. There must be provision for admission to a hospital bed following surgery should this prove necessary.

v. Resuscitation facilities must be available and the staff trained in their use.

2.1.5. Staffing Levels

i. Ophthalmic services should be provided by a suitably trained workforce which can be drawn from various professions. The minimum number of ophthalmic consultants required for a consultant based service can be calculated on the basis of one consultant per 70,000 population, provided that there is adequate support from other professionals which will include some ophthalmologists in training, non-consultant career grade staff, ophthalmic nurse practitioners, orthoptists, optometrists, and other ophthalmic assistants.

ii. In teaching hospitals where there are specialist registrars and undergraduate medical students, consultant sessions are needed both to supervise training and to provide the necessary teaching. As the service commitments of trainees are reduced either for educational reasons, or because of manpower planning requirements, or because of statutory restrictions on their hours of work, increasing use may be made of consultant or non-consultant career grade ophthalmologists or other professionals. it is recommended that in undergraduate teaching hospitals there should be a minimum of one consultant per 50,000 population.

iii. Clinical tasks which have previously been undertaken by junior doctors can be delegated to non-medical personnel following training and validation as recommended by the General Medical Council (Good Medical Practice, GMC 1995). The Royal College of Ophthalmologists has proposed the use of modular ophthalmic skills certificates as evidence of competence in particular ophthalmic tasks.

iv. No ophthalmic unit should be staff by a single consultant working in isolation. Smaller eye units should have a minimum number of two consultants, although experience suggests that the appointment of a third consultant may lead to more efficient use of resources.

v. Locum consultant appointments should be restricted to an initial period of six months and should only be extended for a further six months after consultation with the College (Quality Framework for HCHS Medical and Dental Staffing, 1997).

vi. There should be effective links with medical staff in other specialties.

2.1.6. Service Design

i. Hub and spoke - the recent trend to amalgamate eye departments has resulted in a service model which provides a full range of ophthalmic services within a region through a variety of units.

A larger centralised "hub" unit includes inpatient surgery, subspecialty expertise and specialist investigations.

One or more satellite ("spoke") units offer day surgery (with admission facilities if necessary) and outpatient facilities. Outpatient clinics in the peripheral unit should have provision for a minimum of two doctors and an orthoptist and conform to 2.1.1.

Some units may also offer outpatient clinics in a community setting ("outreach clinics") in order to provide better access to secondary ophthalmic care where it is difficult for patients to be transported to hospital.

It is essential that the standards of care in the satellite units are no less than in the main centre forming the hub.

ii. Clinical networks - may provide tertiary services over several "hubs" at a supra-regional level in particular highly specialised clinical areas.

iii. Ophthalmic emergencies - there should be appropriate access to expert ophthalmic care for patients with serious eye injuries or requiring urgent treatment. in larger units with inpatient facilities this may be through 24 hour cover by ophthalmic trained staff in the hospital. In smaller units, apart from minor ophthalmic emergencies which can be treated by a general casualty officer, patients may have to be referred. First on call ophthalmic cover may be provided by ophthalmic senior house officers or specialist registrars during the first two years of higher specialist training, or by appropriately trained staff grade ophthalmologists. Consultants should not be first on call. Cross cover with other specialties should be for basic grade cover (i.e. for general medical care) and not for problems of a specialist nature.

2.2 MEASUREMENT OF CLINICAL OUTCOMES

2.2.1. Central to the concept of clinical governance is the belief that it is possible to collect data on the outcomes of clinical practice in a way that allows its quality to be measured. Most clinicians would recognise that there are limitations in its application to many areas of medical practice with the currently available information gathering systems. In surgical specialties, in theory at least, it is easier to identify specific outcome measures although the collection of accurate data may still be difficult. Even small inaccuracies in collection may produce significant discrepancies in outcome figures.

In considering appropriate outcome measures, the College has looked at datasets that reflect areas for which the data can be collected readily and accurately whilst still representing a meaningful quality measurement. The College Audit Department has considerable experience in data collection at both local and national level and information from various national audits can provide a basis for setting standards. It has also been possible to draw on the work of other groups such as the Department of Health's Working Group on Outcome Indicators for Cataract Surgery (1997).

2.2.2. In any system of clinical outcome measurement it is essential to make full allowance for ocular comorbidity and casemix. Unless this is recorded alongside the outcome measure, data comparison is not only meaningless but may be frankly misleading.

2.2.3. It has not yet proved possible to identify meaningful clinical outcome measures for all ophthalmic conditions and procedures. Conditions have been selected either because they are common or because a particular outcome can readily be identified as a quality indicator. More sophisticated information gathering systems should lead to improved outcome measurement in the future and the datasets in the accompanying tables should be regarded as starting points from which to develop later criteria.

2.2.4. For certain chronic conditions (e.g. chronic open angle glaucoma, diabetic retinopathy, age related macular degeneration), a clinical outcome may not be apparent for many years. One outcome indicator in such diseases might refer to blind registration statistics. However, such figures would not be indicative of either an individual doctor's or trust' performance but would be a measurement of how well medicine or the NHS as a whole is performing in the detection or registration of that particular condition. For such diseases it would seem more appropriate to adopt a quality indicator that measures a relevant aspect of the service provision and access in the first instance.

2.2.5. Where IT systems are not yet operational, data collected for separate patient episodes could be achieved on a single A4 sheet with "tick boxes" attached to the clinical notes at the time of admission.

2.2.6. The accompanying tables set out some proposed indicators of clinical quality in ophthalmology.

3. Delivering and Monitoring Standards

Within the NHS in England the collection of data on clinical outcomes is the responsibility of the trusts. The NHS Executive Regional Offices oversee the implementation of local clinical governance arrangements and the Commission for Health Improvement will check that the appropriate procedures are in place. Arrangements for Wales, Scotland and Northern Ireland will differ in detail but will be similar in principle.

3.1. Audit

i. It should be possible to utilise current local systems of clinical audit to collect outcome data for specific diseases/procedures. Clinician involvement in this process is essential if meaningful data are to be assembled. Whether this is through a single designated clinician in a unit or by all clinicians entering their individual results, depends on local arrangements. Experience from audit data collection suggests that it is unwise to rely on lay clerical staff alone in the first instance without clinician involvement.

ii. Clinical audit involves the collection of data other than that which is required to determine the clinical outcome indicator for a particular procedure. Outcome indicators are designed to provide information that can be used as a benchmark of quality for a particular unit. They do not of themselves provide sufficient information for individuals or teams to be able to identify ways of improving quality. In order to facilitate this personal audit, more complex data are needed and these should be collected where necessary in parallel with the basic outcome data.

iii. Audit should therefore produce two separate sets of data - the combined outcome results for a given unit which the regional office and CHI (or NCSB in Scotland) may require and, within the unit, more detailed information for the individual clinician.

3.2. Significant Event (Critical Incident) Analysis

This process should provide a record for clinicians and management of events in ophthalmological practice which could potentially be associated with adverse outcomes. There should be prompt analysis and regular review of such incidents. This should involve the whole ophthalmic team, not just ophthalmologists and, where appropriate, action must be taken to minimise risks of further similar incidents

The following should be regarded as significant events in patient care:

i. Operation on the wrong eye.

ii. Wrong operation on correct eye.

iii. Missing case notes at surgery.

iv. Penetration or perforation of globe during periocular injections.

v. Expulsive haemorrhage during surgery.

vi. Endophthalmitis following surgery. vii. Patient collapse requiring resuscitation during surgery.

viii. Death.

ix. "Open" category for incidents causing concern among staff for whatever reason

The following should also be routinely examined to determine whether a critical incident has occurred:

x. Unplanned return to the operating theatre within 28 days of surgery for treatment of the same eye.

xi. Unplanned readmission to an eye unit within 28 days of surgery for treatment of the same eye.

xii. Unplanned transfer or referral of patients to other ophthalmic units within 28 days of surgery.

3.3. Complaints Monitoring

Apart from using published clinical indicators and audit, trusts will also check quality through complaints monitoring procedures.

3.4. College Inspections

College inspections are presently carried out on a quinquennial basis for the purpose of monitoring training standards throughout the UK. The college visitors usually take note of the facilities and service provision in a unit where they are seen to affect training. They have an important role in maintaining a suitable balance between quality of training and service provision.

Such visits will also take place in non-training eye units if so requested in order to advise on quality issues to support clinical governance.

3.5 Continuing Professional Development

i. The General Medical Council has stated that specialist and general practitioners must be able to demonstrate, on a regular basis, that they are keeping themselves up to date and remain fit to practise in their chosen field.

ii. Continuing professional development (CPD) is a process of lifelong learning for individuals and teams which enables professionals to expand and fulfil their potential. In the context of the NHS it can be designed to meet the needs of patients and deliver the health outcomes and healthcare priorities of the NHS as well as the needs of the individual. Although it includes elements of continuing medical education (CME), the process goes beyond the present system of collecting CME points, as it includes an assessment of individual and organisational needs and the development of "personal development plans" in order to identify the direction that the CPD/CME is to take.

iii. Continuing medical education is presently a voluntary system for UK consultants and non-consultant career grade doctors. It could become mandatory if trusts made it a contractual obligation. As the College already maintains a register of consultants and non-consultant career grade doctors under the present system, such a change could be accommodated without undue difficulty.

3.6. Revalidation

This document will form the basis of the revalidation process for individual practitioners suggested by the General Medical Council. The GMC has agreed that the regular demonstration by all registered doctors that they remain fit to practise in their chosen field is best assured by a link with continued registration. A system by which local profiling arrangements are subject to external review has been proposed and the GMC is currently drawing up plans for a fully worked up model of the revalidation of all doctors.

4. Improving Standards

4.1. Individual clinicians expect to work towards improving standards through local audit leading to modification to their existing practice or techniques. Local audit also serves to improve the performance of the ophthalmic team which may include other health professionals. CPD/CME can be similarly employed either at an individual or team level.

4.2. The audit of clinical outcomes is most likely to produce benefit where it can be measured against clearly understood clinical standards. The National Institute for Clinical Excellence (NICE) and the National Clinical Standards Board (NCSB) in Scotland are being designed to set evidence-based standards along with the college's own guidelines.

4.3. The College is likely to become involved when local systems have identified evidence of substandard care but local mechanisms have been unable to define and resolve the problem. At this stage, local trust managers will be encouraged to seek advice from the College directly, or from regional advisers or other relevant professional bodies. Although the General Medical Council has developed formal procedures to investigate poor performance of an individual clinician, the College can be asked to assist trusts at an earlier stage of such an enquiry.

4.4. The Academy of Medical Royal Colleges and the BMA have agreed to co-ordinate their roles in response to a request from a trust for assistance in dealing with a clinical governance problem. Colleges expect to respond on issues relating to standards of care and the way it is delivered. The BMA will take the lead in advising on discipline and health matters.

4.5. If a trust seeks the assistance of the College in relation to the performance of either an individual clinician or a unit, the trust should:

i. Clearly define the problem.

ii. Provide the results of relevant audits.

iii. Demonstrate that it has done all that could reasonably be expected to resolve the problem.

iv. Seek the support of all the local clinicians for an external peer review.

v. Agree the terms of reference and methodology of the proposed review with the College.

vi. Indemnify the review team and the College.

vii. Provide adequate administrative support for the review team.

viii. Reimburse the direct expenses of the review team.

ix. Share a summary of the report with the College.

4.6. The College will undertake to produce a report for a trust and will:

i. Act expeditiously.

ii. Appoint a review team of peers, including representatives of other professional organisations as appropriate.

iii. Interview relevant medical and non-medical staff (including all consultants) in the unit.

iv. Assess the results of audit/surgical outcomes.

v. Discuss the draft report with the local clinicians involved.

vi. Monitor the methodology and the outcome of such reviews to inform future policy and advice.

vii. Inform the GMC if circumstances so require. The College has arranged such visits in the past and has been able to provide a confidential report to the trust.

4.7. Retraining of clinical staff may be required and the College may be able to facilitate the necessary training through other eye units. However, it should be noted that where deficiencies in surgical skills have been identified, there may be special difficulties in obtaining the appropriate retraining through another trust

4.8. Other bodies such as the Commission for Health Improvement (CHI) may be approached by trusts directly to act to improve standards but trust managers will be encouraged to seek advice from relevant professional bodies as an alternative in the first instance.

4.9. The GMC may be involved if a doctor's fitness to practise is called into question. The GMC booklet Maintaining Good Medical Practice outlines the procedures adopted in reviewing a doctor's conduct, health and performance.

6. References

The Royal College of Ophthalmologists:

The Hospital Eye Service, 1996
Cataract Surgery, 1995 (under review)
Ophthalmic Services for Children, 1994
Anaesthesia, 1993 (under review)
Shared Care - Glaucoma, 1996
Guidelines for Diabetic Retinopathy, 1997
Guidelines for the Management of Ocular Hypertension and Primary Open Angle Glaucoma, 1997
Retinopathy of Prematurity, 1995
Chloroquine, Hydroxychloroquine and the Eye, 1998
Registration and Rehabilitation of the Visually Handicapped, 1994
Guidelines for the Recognition of Units Involved in Basic Specialist Training in Ophthalmology (UK), 1995
Guide for Specialist Registrar Training in Ophthalmology, 1997
Continuing Medical Education, 1998

General Medical Council

Good Medical Practice, July 1998.
Maintaining Good Medical Practice, July 1998.
Performance Procedures: a Guide to the New Arrangements, November 1997.
When Your Professional Performance is Questioned, November 1997.

Government White Papers

A First Class Service: Quality in the New NHS, 1998 (Department of Health, England)
Putting Patients First: Quality, Care and Clinical Excellence, 1998 (Welsh Office Department of Health)
Designed to Care: Renewing the National Health Service in Scotland (The Scottish Office Department of Health, 1998)
Fit for the Future: Consultation Paper on the Future of the Health and Personal Social Services, 1998 (Department of Health and Social Services, Northern Ireland)

NHS Executive

The NHS (Appointment of Consultants) Regulations 1996 - Good Practice Guidance.
Quality Framework for HCHS Medical and Dental Staffing, April 1997.
Clinical Governance: Quality in the New NHS, 1999 (PO Box 40, Wetherby LS23 7LN)

Other Publications

P Courtney. The National Cataract Surgery Survey: I. Method and Descriptive Features. Eye (1992) 6: 487-492.
P Desai. The National Cataract Surgery Survey: II. Clinical Outcomes. Eye (1993) 7: 489-494.
P Desai. The National Cataract Surgery Survey: III Process Features. Eye (1993) 7: 667-671.
Bailey C C, Sparrow J M, Grey R H B, Cheng H. The National Diabetic Retinopathy Laser Treatment Audit: I Maculopathy. Eye (1998) 12: 69-76.
Bailey C C, Sparrow J M, Grey R H B, Cheng H. The National Diabetic Retinopathy Laser Treatment Audit: II Proliferative Retinopathy. Eye (1998) 12: 77-84.