Bennett M J, Tershakovec A M, Cortner J A, Shannon B M
Lipid Heart Research Center, Children's Hospital of Philadelphia, Pa.
Am J Dis Child. 1993 Mar;147(3):340-5. doi: 10.1001/archpedi.1993.02160270102031.
To develop an easy to use quality assurance program for the measurement of capillary blood cholesterol levels in private pediatric practices. The program needed to comply with the guidelines laid down by the National Cholesterol Education Program.
Intervention study.
Nine private pediatric practices in and around northern Philadelphia, Pa.
The analysts included clinic staff members with laboratory expertise ranging from none to some previous experience. None of the participants had previous experience with a quality assurance program.
Progress was reported monthly to the Lipid Research Laboratory, Philadelphia, and action was taken to correct inaccuracies in bias or variance.
Compliance with the analytical guidelines laid down by the National Cholesterol Education Program in that the coefficient of variation was no greater than 5% and the bias was no greater than +/- 5% in the first year of the study.
Within the first year of the study, there were 152 monthly quality assurance returns for each of two lyophilized control materials. On four occasions the coefficient of variation was greater than 5% while the overall bias was within the desired +/- 5% on 143 (94%) of 152 occasions. After the first 3 months of the study, as user confidence increased, intervention by the Lipid Research Laboratory became minimal. The internal quality assurance was further evaluated by a successful performance in a quarterly external quality assurance program.
It is possible to devise an easy to use quality assurance program for extra laboratory measurement of cholesterol levels in children, and, with minimal assistance, maintain acceptable standards of cholesterol analysis. The quality assurance improved following the first 3 months of training and education. Subsequent continuous quality improvement was maintained with minimal involvement of the specialist center. Should the controversial issue of private office measurement of blood cholesterol levels become universally acceptable, the implication from our study is that standards acceptable to the National Cholesterol Education Program and the Clinical Laboratory Improvement Amendments of 1988 are possible using a suitable quality assurance program.
为私立儿科诊所制定一个易于使用的毛细血管血胆固醇水平测量质量保证计划。该计划需符合国家胆固醇教育计划制定的指南。
干预性研究。
宾夕法尼亚州费城北部及其周边的九家私立儿科诊所。
分析人员包括临床工作人员，其实验室专业知识水平从无到有一定前期经验不等。所有参与者此前均无质量保证计划方面的经验。
每月向费城脂质研究实验室报告进展情况，并采取措施纠正偏差或方差方面的不准确之处。
符合国家胆固醇教育计划制定的分析指南，即研究第一年变异系数不超过5%，偏差不超过±5%。
在研究的第一年，两种冻干对照材料每月各有152次质量保证回报。有4次变异系数大于5%，而在152次中有143次（94%）总体偏差在期望的±5%范围内。研究开始3个月后，随着用户信心增强，脂质研究实验室的干预变得极少。通过在季度外部质量保证计划中的成功表现进一步评估了内部质量保证。
有可能为儿童胆固醇水平的实验室外测量设计一个易于使用的质量保证计划，并在最少的协助下维持可接受的胆固醇分析标准。经过最初3个月的培训和教育，质量保证得到改善。随后在专科中心极少参与的情况下维持了持续的质量改进。如果私人诊所测量血胆固醇水平这一有争议的问题变得普遍可接受，我们的研究表明，使用合适的质量保证计划可以达到国家胆固醇教育计划和1988年《临床实验室改进修正案》认可的标准。
