Dr. Shroff's Charity Eye Hospital, New Delhi, India.
Samagra Development Associates Private Ltd, New Delhi, India.
Indian J Ophthalmol. 2018 Mar;66(3):389-393. doi: 10.4103/ijo.IJO_861_17.
The aim of this study is to identify quality indicators of the eye bank and validate their effectivity.
Adverse reaction rate, discard rate, protocol deviation rate, and compliance rate were defined as Quality Indicators of the eye bank. These were identified based on definition of quality that captures two dimensions - "result quality" and "process quality." The indicators were measured and tracked as part of quality assurance (QA) program of the eye bank. Regular audits were performed to validate alignment of standard operating procedures (SOP) with regulatory and surgeon acceptance standards and alignment of activities performed in the eye bank with the SOP. Prospective study of the indicators was performed by comparing their observed values over the period 2011-2016.
Adverse reaction rate decreased more than 8-fold (from 0.61% to 0.07%), discard rate decreased and stabilized at 30%, protocol deviation rate decreased from 1.05% to 0.08%, and compliance rate reported by annual quality audits improved from 59% to 96% at the same time. In effect, adverse reaction rate, discard rate, and protocol deviation rate were leading indicators, and compliance rate was the trailing indicator.
These indicators fulfill an important gap in available literature on QA in eye banking. There are two ways in which these findings can be meaningful. First, eye banks which are new to quality measurement can adopt these indicators. Second, eye banks which are already deeply engaged in quality improvement can test these indicators in their eye bank, thereby incorporating them widely and improving them over time.
本研究旨在确定眼库的质量指标并验证其有效性。
将不良反应率、淘汰率、方案偏离率和合规率定义为眼库的质量指标。这些指标是根据质量的定义确定的，该定义包括两个维度——“结果质量”和“过程质量”。这些指标被作为眼库质量保证（QA）计划的一部分进行测量和跟踪。定期进行审核，以验证标准操作规程（SOP）与监管和外科医生接受标准的一致性，以及眼库内开展的活动与 SOP 的一致性。通过比较 2011 年至 2016 年期间的观察值，对这些指标进行了前瞻性研究。
不良反应率下降了 8 倍以上（从 0.61%降至 0.07%），淘汰率下降并稳定在 30%，方案偏离率从 1.05%降至 0.08%，年度质量审核报告的合规率从 59%提高到 96%。实际上，不良反应率、淘汰率和方案偏离率是领先指标，而合规率是滞后指标。
这些指标填补了眼库质量保证文献中的一个重要空白。这些发现有两种意义。首先，对于新开展质量测量的眼库，可以采用这些指标。其次，对于已经深入参与质量改进的眼库，可以在其眼库中测试这些指标，从而广泛采用这些指标并随着时间的推移不断改进。
