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Grading and Quality Assurance
Screener obtaining at least two images from each active eye Patients head positioned on the retinal camera chin rest Dilation of pupil

MODULE 4: Providing Primary, Secondary and Arbitration Grading Services and Referring Patients, Quality Control and Quality Assurance Services

4.1 The Requirement
The NSC has detailed a range of grading processes, quality assurance and clinical governance requirements in this area. These introduce many requirements to ensure that the number of false positives and the number of false negatives are minimised. There are minimum and maximum numbers of image sets to be graded per annum and comprehensive annual reporting requirements. Generally the requirement is to have more than one person involved in the grading of patient images (where there are any findings or doubts over the grade) and also to undertake random checks of graders work to assure quality and improve grader proficiency. The Screening and Grading Service should also be supported by a medical director/medical directorate or advisory body and have an element of external quality assurance.

4.2 The Issues
A number of DRS programmes use Retinal Screeners or Community Optometrists to undertake the primary grading role and a senior Retinal Screener to undertake the secondary grading of images. There are often issues with the arbitration arrangements and the quality assurance and clinical governance processes. External Quality assurance and the support of a Medical Director are also not always in place. There are capacity issues and competence issues that are common within this area. For example, some DRS programmes experience delays of several months in grading the image sets and issuing patients their results. Where the grading service has problems, this may results in more referrals to Ophthalmology which could otherwise be avoided - saving the patient anxiety and the Commissioners money.

4.3 The Solution

1st Retinal Screen Grading Service has a number of elements detailed below; however the key approach is to deliver high quality grading using Ophthalmologists for secondary and arbitration grading in order to ensure an efficient screening and treatment service. Our grading services can be used to catch-up where delays are present, or simply provide a high quality service with significant capacity (we have many Ophthalmologists under contract).

This module may be provided independently of other modules. For example, it may be provided as part of an existing programme to deliver extra grading capacity. There are two options:

  1. 1st Retinal Screen can operate with licensed PASA approved Grading Software or
  2. 1st Retinal Screen can be provided with access to your programme-specific software.
  • Primary Grading (Level 1) - Primary grading is undertaken either by the Retinal Screener or where a Photographic only service is provided; Primary Grading may be delivered separately. It aims to establish if there is disease present.
  • Secondary Grading (Level 2) - if non-negative, patient image sets will be graded by an Ophthalmologist level grader.
  • Arbitration Grading (Level 3) - deals with disagreements between primary and secondary grading.
  • Quality Control and Assurance - Integration between screening and treatment service elements:
    • If no disease is found, 10% will be re-checked automatically by an ophthalmologist for quality assurance purposes and to effect a programme of continuous improvement
    • An additional QA, 10% (or higher) of the Ophthalmologists gradings are checked by an Arbitration Ophthalmologist
    • We engage a Medical Director to oversee the entire grading process
    • Associated medical malpractice insurance is in place, with cover up to £5 million
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