early detection (and treatment if needed) of diabetic retinopathy as part of a systematic programme that meets national standards.

12.5Systematic DR Screening

The following were considered to be core ingredients of systematic screening for the English Screening Programme:

¥Full population coverage and secure identiÞcation of cohort

¥Minimum programme size of 12,000 people with diabetes

¥Single-collated list with call/recall being managed from a single centre supported by a dedicated team of administrators

¥Careful and systematic management of exclusions to ensure these are kept to a minimum

¥Trained and accredited personnel

¥Two-Þeld digital photography of each eye with mydriasis

¥First full disease grading of all image sets

¥Second full disease of all abnormal image sets and 10% of normals as recommended for quality assurance for the English programme

¥Arbitration level grading by a medical retinal ophthalmologist on difference of referral

¥Slit-lamp biomicroscopy of all ungradable image sets

¥Effective referral and treatment with process to ensure accurate feedback to programmes to Ôclose the loopÕ

¥The production of an annual report

12.6Cameras for Use in the English Screening Programme

In 2006, framework contracts were developed with suppliers of non-mydriatic digital cameras that met the following criteria:

1.Image Þle storage formats should not result in the loss of any clinically signiÞcant information.

2.The original images, as output by the camera, should be a minimum of 20 pixels per

degree of retinal image, both horizontally and vertically.

3.The Þeld of view, as permanently recorded, should be a minimum of 45¡ horizontally and 40¡ vertically.

4.Pictures should be viewed in a manner that minimises the chance of missing any clinically signiÞcant detail.

5.All retinal cameras should be CE marked.

It was considered that non-mydriatic digital cameras were the preferred camera to use in the English Diabetic Retinopathy Screening Programme, even though mydriasis is routinely undertaken.

A new framework for procurement of cameras for use in the National Screening Programme to replace the existing camera contracts was developed in 2009. This also included testing all the cameras with some patients with known retinopathy lesions. It also included a modiÞcation to the speciÞcation that the original images, as output by the camera, should be a minimum of 30 pixels per degree of retinal image, both horizontally and vertically, which will result in some older cameras that are no longer suitable to be retired.

12.7Software for Use in the English Screening Programme

A national procurement for management software for the National Screening Programme was carried out in 2003, leading to four approved suppliers of management solutions. Two of these approved suppliers are providing the majority of software for the National Programme.

12.8A Simplified Grading Form

It has actually been very difÞcult to standardise a grading form in England because so many clinicians felt that the form that they had developed was superior to any other form. We have tried to specify the main headings and deÞned the terms within this but stated that

services are welcome to develop as many subcategories as they wish as long as it is possible to compare the numbers under the main headings (Table 12.1).

12.9Implementation in England

The implementation of systematic screening in England proved difÞcult because funding for

health-care services had been devolved to 303 Primary Care Trusts in England.

By November 2005, there were only 15 programmes that were considered to be running a systematic screening service, with 54 at the advanced stages of planning or missing key features of a systematic programme and 36 that were at an early planning stage.

By November 2006, this number had risen to 42 running a systematic service, 56 at an advanced

planning stage and only 6 at an early planning stage.

By November 2008, all programmes had implemented a screening service, and an external quality assurance programme had commenced to measure these services against 20 quality assurance standards.

their screening programme and should match their job role. Recommended units according to job role can be found in the scheme handbook. Additional units must be taken by candidates if their job role extends beyond the six units in the award.

In 2009, it became possible to achieve a diploma by passing eight units.

For those staff who wish to achieve at a higher

Retinopathy competencies completed four nations collaboration and were approved as National Occupational Standards in February 2005. A course was developed in conjunction with an NHS University. The pilot phase of the accreditation process was completed in 2006 with City and Guilds as the awarding body, and the resulting certiÞcate qualiÞcation was rolled out as an accreditation of the minimum level of competence required by all personnel involved in the identiÞcation of sight-threatening diabetic retinopathy in the English National Screening Programme.

The core mandatory units are:

Unit 1: National Screening Programmes, principles, processes and protocols

Unit 2: Diabetes and its relevance to retinopathy screening

Unit 3: Anatomy, physiology and pathology of the eye and its clinical relevance

Optional units:

Unit 4: Preparing the patient for retinopathy screening

Unit 5: Measuring visual acuity and performing pharmacological dilatation

Unit 6: Imaging the eye for the detection of diabetic retinopathy

Unit 7: Detecting retinal disease

Unit 8: Classifying diabetic retinopathy

Unit 9: Administration and management systems in a retinopathy screening programme Each unit can be individually certiÞcated, or

a candidate can enrol for the whole award. The whole award (Level 3 CertiÞcate in Diabetic Retinopathy) is made up of the three mandatory units and three optional units. The units chosen by a candidate must be agreed with

University of Warwick.

12.11 Quality Assurance

A pilot study [4] of ten existing services was undertaken to inform the development of the current 20 QA standards [9] for the English Programme, which are periodically reassessed and revised.

The 20 QA standards are:

1.To reduce new blindness due to diabetic retinopathy

2. To invite all eligible persons with known diabetes to attend for the DR screening test

3.To ensure database is accurate

4.To maximise the number of invited persons accepting the test

5.To ensure photographs are of adequate quality

6.To ensure grading is accurate

7.To ensure optimum workload for graders, to maintain expertise

8.To ensure timely referral of patients with R3 (fast-track) screening results (e-mailed or faxed)

9. To ensure GP and patient are informed of all test results

10.To ensure timely consultation for all screenpositive patients

11.To ensure timely treatment of those listed by ophthalmologist

12.To minimise overall delay between screening event and Þrst laser treatment

13.To follow up screen-positive patients (failsafe)

14.To minimise the anxiety associated with screening due to inappropriate referral

15.To ensure timely rescreening

16.To ensure that the public and health-care professionals are informed of performance of the screening programme at regular intervals

17.To ensure the service participates in quality assurance

18.To optimise programme efÞciency and ensure ability to assure quality of service

19.To ensure that screening and grading of retinal images are provided by a trained and competent workforce

20.To ensure timely biomicroscopy assessment of patients deemed unobtainable/raw ungradable or inadequate (unassessable)

The criteria that are used to measure against these objectives are:

1.(a) Annual new certiÞcations of blindness / partial sight, predominantly due to diabetic retinopathy, compared to 1990/1991 rates of 9.5 and 9.3, respectively, per million per annum (national data).

(b)Local identiÞcation of incident visual acuity predominantly due to diabetic retinopathy: 6/60 or worse in the better seeing eye [LogMAR equivalent +1.0].

(c)6/18 or worse in the better seeing eye [LogMAR equivalent +0.5].

(d)Local services will need to prospectively audit both certiÞcations of visual impairment and incidence of speciÞed visual acuity in order to establish a baseline.

2.Completeness of database:

(a)Proportion of GPs participating.

(b)Percentage of known people with diabetes on register.

(c)Percentage of eligible people with diabetes invited.

(d)Single-collated list of all people with diabetes.

(e)Systematic call/recall from a single centre of all people eligible for screening on the collated list.

(f)All newly diagnosed patients must be offered screening within 3 months of the programme being notiÞed of their diagnosis.

3.Accuracy of addresses on database of persons age 12 or more, as determined by post ofÞce returns.

4.Percentage of eligible persons accepting the test:

(a)Initial screen

(b)Repeat screen

5.Percentage ungradable patients in at least one eye.

6.Interand intragrader agreement:

(a)For referable images

(b)For non-referable images

(c)Ungradable images

7.Minimum number of image sets graded per annum for:

(a)Optometrists/ophthalmologists

(b)All other screener/graders

8.Time between screening encounter and issue of referral request was ßagged by screener/ grader as R3 fast-track referral and where secondary grading and appropriate referral actioned within 1 week.

9.Time between screening encounter and issuing of result letters to GP and patient.

10.Time between notiÞcation of positive test and consultation for:

(a)Proliferative DR/advanced DED, R3

(b)PPDR, R2

(c)Maculopathy, M1

(d)All above retinopathy grades

11.Time between listing and Þrst laser treatment, following screening for:

(a)Proliferative DR, R3

(b)Maculopathy, M1

12.Time between screening encounter and Þrst laser treatment, if listed at Þrst visit to hospital eye service following screening, does not exceed a speciÞed time:

(a)For patients referred as R3

(b)For patients referred as M1

13.Combined cancellation and DNA rate for ophthalmology clinic:

(a)For PDR [R3] within 1 month

(b)For PPDR [R2] within 6 months

(c)For maculopathy within 6 months

14.Monitor inappropriate referrals following screening:

(a)False-positive rate of DR test (photograph)

(b)Neither photograph nor clinical examination warranted referral

15.Time to rescreening compared to annual screening interval.