Abstract
Purpose Autologous serum may be prescribed to patients suffering from severe dryness of the eye that cannot be relieved by conventional pharmaceutical eyedrops. They are prepared from the patient‘s own blood, processed to serum.
Methods Implementation of serum droplet preparation within the hospital comes with both legal and logistic challenges that were solved by in-depth communication between the various involved departments. Legally, in Belgium, the apothecary is responsible for the release of the droplets and to ensure qualitative serum preparation, overruling legislation related to tissue donation as the droplets are considered “medication”. However, the apothecary is allowed to outsource the processing and testing, remaining ultimately responsible for the final product. The blood needs to pass by the tissue bank and an informed consent form is required. The processing and release of serum droplets was limited to a few persons a week due to the high workload at the apothecary. Inclusion of the tissue bank for processing ensured higher patient numbers became feasible, while maintaining high quality standards.
Results Practically, the following workflow was developed. The process is initiated by the ophthalmologist, presenting the informed consent form to the patient in need of serum eye drops. The patient is referred to the blood collection unit where the blood sample is taken. The blood sample is transported to the tissue bank, the blood is kept at room temperature in rest for two hours, it is centrifuged and the serum is kept refrigerated overnight, allowing time for the serological tests and for the release from tissue bank to apothecary. The next day, the serum is processed to eye drops in the tissue bank, after which they are released and transported to the apothecary, and eventually picked up by the patient. It was decided to not perform microbiological testing on each batch of eye drops, as the droplets are sterilized through a 20 micron filter, waiting for the results would significantly increase the waiting time for the patient, and the expensive tests would have to be paid by the patient as the treatment is not reimbursed in Belgium. Instead, an initial validation of sterility was performed, followed by one microbiological test per three months.
Conclusions Though coming with significant legal and logistic challenges, we successfully implemented an efficient workflow for autologous serum droplets in our hospital.
