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.
| CLINICAL
OUTCOME MEASUREMENT |
| Condition/Procedure |
Data |
Quality
Indicators |
Evidence/Reference |
| Cataract
extraction and IOL |
Pre-op
best corrected VA. Post-op VA at discharge from hospital. Post-op VA at
final refraction (or 3 months). Co-morbidity (additional diagnoses) |
Post-op:
% achieve 6/12 or better in eyes without co-morbidity or % gain>2 lines
of Snellen VA |
RCOphth
National Cataract Audit 1998/99 |
| Corneal
graft |
Graft
survival |
Clear
graft |
UKTSSA
follow-up data |
| Dacryocystorhinostomy |
Epiphora
(absent, improved no change) |
%
free of epiphora at hospital discharge or 3 months |
|
| Retinal
detachment |
Anatomical
re-attachment at ... weeks after first time surgery |
% |
RCOphth
audit |
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.
|