6.0 SAFETY AND EFFECTIVENESS OF SERVICE
To ensure the proposed service meets national standards in terms of safety and effectiveness, for staff and patients in my care with undiagnosed or delayed CD, the following measures would be put in place:
· Pharmacy will provide a training facility for pharmacists and staff involved in the provision of the service to use the Simtomax POC handheld device (similar to the device used in testing cholesterol in community pharmacies) to identify patients at risk of CD. Pharmacists must be accredited to provide the service by taking and passing an online module on Recognition and Management of Coeliac Disease via CPPE website.
· The pharmacy uses Simtomax POCT device which is non-invasive requiring a relatively small volume (25microlitre) of blood from a finger prick. The POC testing is estimated to cost between £17-£20 per test, making it cost-effective in contrast to a laboratory testing. It is reliable with a sensitivity and specificity rate of 90-97% and 79-100% respectively, providing an instant result, normally within 5-10 minutes to facilitate a quick referral of patients to see their GP (Mooney et al., 2013).
· Staff conduct screening test as detailed in the SOP in collecting patient’s blood sample, analyzing and interpreting results. Staff is aware of proper disposal of sharps, contaminated materials and maintaining a hygienic work area. A needle stick injury procedure will be in place and all staff involved in the service are offered immunisation against Hepatitis B.
· The pharmacy will have a SOP in place which is agreed by all stakeholders. The pharmacy will have a nominated pharmacist as a clinical lead to ensure a safe and effective service is offered to the public. They will also ensure patients information taken during the service are safe and confidential by using a secured computerised system of holding records.
· A consultation room for the provision of the service would not only provide a sufficient level of privacy but provides appropriate protective equipment such as gloves, sharp bins, bins for safe disposal of clinical wastes, aprons, antiseptic wipes, hand washing soap, lancing devices, gauze and plasters for a safe service. ?
· The pharmacy to periodically calibrate device to maintain its functionality as per SOP. An internal quality control is carried out as advised by the manufacturer to monitor and detect errors in the testing procedure. However, this control measure does not factor sample collection and handling technique, patients already on gluten-free diet at the time of testing, and those with existing IgA-tTG antibody deficiency. Also the Simtomax test is not suitable for patients under the age of 18 years in which IgA is too low for accurate detection.