ABSTRACT
BACKGROUND: The aim of this study was to explore how the implementation of the quality management system (QM; according to DIN EN ISO 9001â:â2008) 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.
Subject(s)
Corneal Transplantation , Eye Banks , Cornea , Humans , Retrospective Studies , Tissue DonorsABSTRACT
BACKGROUND AND PURPOSE: With the discrepancy between availability and demand for corneal donors, the purpose of our study was to identify significant factors influencing the suitability and affecting the main reasons for discarding organ-cultured corneas. We thus aimed to minimise the percentage of unsuitable corneas in the long term. PATIENTS AND METHODS: 4140 corneas of 2083 donors were analysed between 2006 and 2016. The factors included age, gender and medical history of the donors as well as storage factors such as post-mortem times. The data was recruited in a Microsoft Access database and evaluated with SPSS 20.0, using logistic regression analyses. In a multiple regression model, six factors influencing the suitability of the donor tissue were analysed. All corneas that did not meet the criteria for elective keratoplasty were considered unsuitable. RESULTS: A high donor age of > 80 years was found to be a significantly negative factor on the suitability of the cornea (p = 0.001) compared to the reference group of donors < 40 years. Previous cataract surgery (p < 0.001) also significantly reduced suitability. Male corneas were significantly less suitable than female corneas (p = 0.028). Hypertension (p = 0.612), chemotherapy (p = 0.745) or diabetes mellitus (p = 0.321) did not significantly affect the suitability. Sepsis (p = 0.026) and multiorgan failure (p < 0.001) as cause of death resulted in significantly higher discarding rates due to contamination of the culture medium. Corneas in which the blood sample collection took more than 12 h from death of the donor had to be discarded significantly more frequently due to a positive donor serology. CONCLUSIONS: Factors such as a history of cataract surgery and high donor age reduced the suitability of corneal donor tissue in organ culture. Diabetes, arterial hypertension and chemotherapy in the donor history did not statistically significantly affect the suitability of donor tissue. Causes of death such as sepsis or multi-organ failure increased the contamination rate of the medium. Post-mortem blood collection after more than 12 h should be avoided due to increased positive serology results.
