Centralized Provision of Autologous Serum Eye Drops as an HA-wide Service

Abstract Description

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Authors (including presenting author) :

Wong CK(1), Wong VWY (2), Sin NC(3), Leung CM(2), Leung JNS(1), Tsoi WC(1), Lam NM(2), Lee CK(1)

Affiliation :

(1)Hong Kong Red Cross Blood Transfusion Service, (2)Hong Kong Eye Hospital, (3)HAHO Quality and Safety Division

Introduction :

Autologous Serum Eye Drop (ASED) is an established useful treatment for patients with severe ocular surface disease in use for over three decades. Serum contains a large number of epitheliotrophic factors, which offers therapeutic protection to severe dry eyes intractable to conventional therapy. All along, ASED are produced using non-standardized locally developed methods at research laboratories, pathology laboratories and clinical areas at different HA ophthalmology units. The quality of the products and the risk of bacterial contamination are of concern.

Objectives :

To develop a centralized ASED preparation service at the BTS for HA patients.

Methodology :

In developed countries such as the UK, Australia and New Zealand, manufacturing of ASED is centralized and performed by blood services using national standardized protocols. A feasibility study was conducted by the Hong Kong Red Cross Blood Transfusion Service (BTS), making reference to international recognized protocols, in July 2018 and concluded that centralized provision of ASED at BTS is feasible. Operating procedures for blood collection, manufacture, testing, storage and distribution of ASED were devised with the concerted efforts of the BTS and Coordinating Committee (Ophthalmology) as well as inputs from HAHO Quality and Safety Division and Chief Pharmacist’s Office.

Result & Outcome :

The new service was commenced in the first quarter of 2019 with workflow as follows: (a) ASED treatment is provided at 3 HA hospitals, viz. PWH, HKEH and TMH. Ophthalmologists prescribe ASED to indicated patients and appointment will be arranged with BTS after obtaining informed consent. (b) About 100 mL whole blood is collected after health check including questionnaire compliance, physical examination and screening for haemoglobin level as well as meticulous disinfection at venepuncture site. (c) Serum is extracted after complete clotting and centrifugation in a closed system. After dilution with normal saline, ASED is dispensed into tear drop bottles inside a biosafety cabinet and frozen. (d) After clearing of infectious markers screening and bacterial surveillance, packaged ASED, for 31-day use, is delivered to respective eye clinics of the requesting hospitals, which is then ready for collection. Application and storage instructions are provided by hospitals. In conclusion, centralized provision of ASED is a successful collaborative project with enhanced clinical safety, clinical governance and risk management.