How Implementing a Quality Management System at the LIONS Eye Bank Saar-Lor-Lux, Trier/Western Palatinate from 2006 to 2016 Impacted the Rate and Reasons for Discarding Human Organ-Cultured Corneas

Abstract

Background The aim of this study was to explore how the implementation of the quality management system (QM; according to DIN EN ISO 9001 : 2008) at the LIONS Eye Bank impacted the rate and reasons for discarding donated corneas. The QM system was introduced in November 2010. Material and methods The rate of and reasons for discarding cornea tissues at the LIONS Eye Bank Saar-Lor-Lux,Trier/Western Palatinate from 2006 to 2016 were analysed retrospectively. 4,140 corneas from 2,084 donors were analysed. 1,640 corneas were processed before the QM system had been introduced and 2,500 corneas thereafter. Main reasons for discarding cornea tissues were endothelial quality, contamination of the medium and a positive conjunctival swab. The data was extracted from clinical files and data filing systems, entered into a Microsoft Access database and analysed statistically with SPSS. Outcome Following the implementation of a QM system, the discard rate decreased significantly from 50.1% to 39.7% (p < 0.0001). Prior to the implementation of the QM system, 493 (30.1%) cornea tissues had been discarded due to endothelial quality, while this figure improved significantly to 604 (24.2%) after the QM system had been implemented (p < 0.0001). Contamination was the reason for discarding tissue in 173 (10.5%) cases before implementation of the QM system, and in 124 (5.0%) cases thereafter (p < 0.0001). Positive conjunctival swab was the reason for discarding tissue in 10 (0.6%) cases before the QM system had been implemented, and in 53 (2.1%) cases thereafter (p < 0.0001). Conclusion Implementation of a QM system significantly reduced the rate of discarded donor tissue in the LIONS Eye Bank. Better management of contamination as a reason for discarding cornea tissues can be attributed to improved standards, protocols and training that are part of this QM system.

Prevalence and severity of cornea guttata in the graft following Descemet Membrane Endothelial Keratoplasty (DMEK)

“…It should be noted that, when looking at a retrospective study conducted by the Lions Eye Bank, the mean donor age from 2006 to 2016 was 70.3 AE 15.0 years. This study showed that the main reasons of non-suitable potential donors in the eye bank were a decreased endothelial cell quality and higher donor ages above 80 years (Kramp et al 2020;Laun et al 2021).…”

Trends in Corneal Transplantation and Characteristics of Donors in the Chongqing Eye Bank, China: A Retrospective Study, 1999–2018

“…Cornea arcus senilis was one of the causes of poor corneal quality as well as corneas with an endothelial cell count below 2,000 per mm 2 . Both factors are known to be associated with donor age (27,29) and as mentioned earlier, the average age of donors was older than 50 years. A previous study has reported a similar result showing that a high donor age (>80 years), compared to younger donors (age < 40 years), reduced the final suitability of corneal donor tissue (30).…”

“…The report from India proposed a quality assurance program (QAP) for increasing corneal utilization; such a program would introduce high-level scrutiny of wasted donated tissues, and the authors suggest that such a QAP would improve the corneal utilization rate. Another report from Germany has also found that the implementation of a quality management system and better management of contamination significantly reduces the rate of discarded donor tissue in the eye bank (27). Moreover, technical improvements, such as the application of anterior segment optical coherence tomograph providing a sterile screening method to identify corneal tissues, have further optimized donor selection and increased the utilization rate (28).…”

Prevalence and Impact of Cornea Guttata in the Graft After Penetrating Keratoplasty in Germany

“…It was also found that a high percentage of the discarded grafts were associated with a high donor age (.80 yrs). [17][18][19] The occurrence of CG immediately after PKP suggest that guttae cannot always be reliably detected in the eye bank with the inverted light microscope. However, according to a study performed by Safi et al, 20 several morphological criteria that can be preoperatively detected using inverted light microscopy correlate with the appearance of postoperative CG.…”

“…It was also found that a high percentage of the discarded grafts were associated with a high donor age (>80 yrs). 17–19…”