[1]孔丽蕊,王华丽,吴风.基于风险管理设计临床生物化学酶类检测项目质量控制策略[J].现代检验医学杂志,2019,34(01):154-156.[doi:10.3969/j.issn.1671-7414.2019.01.040]
KONG Li-rui,WANG Hua-li,WU Feng.Quality Control Strategy of Clinical Biochemical Enzyme
Detection Project Based on Risk Management[J].Journal of Modern Laboratory Medicine,2019,34(01):154-156.[doi:10.3969/j.issn.1671-7414.2019.01.040]
点击复制
基于风险管理设计临床生物化学酶类检测项目质量控制策略(
)
《现代检验医学杂志》[ISSN:/CN:]
- 卷:
-
第34卷
- 期数:
-
2019年01期
- 页码:
-
154-156
- 栏目:
-
质量控制·实验室管理
- 出版日期:
-
2019-02-28
文章信息/Info
- Title:
-
Quality Control Strategy of Clinical Biochemical Enzyme
Detection Project Based on Risk Management
- 文章编号:
-
1671-7414(2019)01-
154-03
- 作者:
-
孔丽蕊; 王华丽; 吴风
-
(成都市郫都区中医医院检验
科，成都611730)
- Author(s):
-
KONG Li-rui; WANG Hua-li; WU Feng
-
(Department of Laboratory Medicine，
Chengdu Pidu District Hospital of Traditional Chinese Medicine，Chengdu 611730，China)
-
- 关键词:
-
风险管理; 酶类检测项目; 质量控制策略
- 分类号:
-
R446
- DOI:
-
10.3969/j.issn.1671-7414.2019.01.040
- 文献标志码:
-
A
- 摘要:
-
目的应用基于患者风险管理的统计质量控制程序Sigma-S
QC诺曼图设计临床生物化学酶类检测项目的质量控制策略。方法根
据实验室酶类检测项目Sigma度量值大小不同，应用患者风险参数MaxE(NUF)相关联图形工具
即Sigma-SQC诺曼图，设计日立7180生化分析仪酶类检测项目起始质控程序和过程监测质控
程序。结果Sigma度量值5.1～6.0的项目丙氨酸氨基转移酶(ALT)
、天门冬氨酸氨基转移酶(AST)、碱性磷酸酶(ALP)和肌酸激酶(CK)起始候选质控程序：多规
则MR N4，分析样本量=200，误差检出概率(Ped)=1.00；MR N2，分析样本量=200，Ped=0
.94；过程监测候选质控程序：12.5 s N1，分析批长度=200，假失控概率(Pf
r)=0.01；13 s N1，分析批长度=70，Pfr=0.00。Sigma度量值4.1～5.0的
项目乳酸脱氢酶(LDH)、淀粉酶(AMY)和谷氨酰转肽酶(GGT)，起始候选质控程序：多规则MR
N4，分析样本量=200，Ped=1.00；MR N2，分析样本量=200，Ped=0.94；过程监测候
选质控程序：13 s N2，分析批长度=25，Pfr=0.00；MR N2，分析批长度=50
，Pfr=0.01；13 s N4，分析批长度=70，Pfr=0.01。结论
临床生物化学酶类检测项目ALT，AST，ALP，CK的起始质控程序MR N2，分析样本量=
200，过程监测质控程序12.5 s N1，分析批长度=200；LDH，AMY，GGT的起始
质控程序MR N2，分析样本量=200，过程监测质控程序MR N2，分析批长度=50，MaxE(NU
F)≤1可以最大程度地降低患者风险。
- Abstract:
-
Objective The quality control strategy of bioch
emical enzyme detection project is designed by using the statistical quality con
trol program based on patient risk management Sigma-SQC Norman map．
Methods The initial quality control program and the process monitori
ng program for the biochemical enzyme detection project of Hitachi 7180 biochemi
cal analyzer were designed according to the size of different Sigma metric value
s
using the graphical tool of MaxE (NUF) associated with Sigma-SQC．R
esults Alanine aminotransferase (ALT)，aspartate aminotransferase (A
ST)，alkaline phosphatase (ALP)，creatine kinase (CK) of the Sigma metric value
5.1 to 6.0，and the initial quality control program was multi rule MR N4，an
d the sampl
e size=200．Error positive rate (Ped) was 1.00，MR N2，and the sample size=20
0，error
positive rate (Ped)=0.94．The process monitoring program was 12.5 s
N
1，and the analytical run length=200，Pfr=0.01．13 s N1 analytical r
un le
ngth was 70 and Pfr was 0.00．Sigma metric values 4.1 to 5 of the project lact
ate dehydro
genase (LDH)，amylase (AMY)，gamma-glutamyl transferase (GGT)，and the initial
qual
ity control program were multi rule MR N4．The sample size was 200，PED=1.00．M
R N2，sample size was 200，PED=0.94．Ｔhe process monitoring program were 1
3 s N2，analytical run length=25，Pfr=0.00，and 13 s N4，th
e analytical run length=70，Pfr=0.01．Conclusion The ini
tial quality contro
l program MR N2 of biochemical enzyme detection projects ALT，AST，ALP and CK
，the sample size were 200，and the process monitoring program 12.5 s
N1，the analytical run length was 200．The initial quality control program MR
N2 of biochemical enzyme detection projects LDH，AMY and GGT，the sample size
were 200，the process monitoring program，the analytical run length was 50，MaxE
(NUF)≤1 could minimize the risk of patients．
参考文献/References:
[1］International Organization for standardization．ISO 15 189：2012
．Me
dical laboratories-requirements for quality and competence［S］．General：Swtze
rland ISO 15189：2012，2012．
[2］Clinical and Laboratory Standards Institute.CLSI C2 3-A．Laboratory qua
l
ity control based on risk management［S］．Wayne PA，Clinical and Laboratory Sta
ndards Institute CLSI 23-A，2011．
[3］中华人民共和国卫生部．WS/T 403-2012．临床生物化学检验常规项分析质量指标
［S］．北京：中国标准出版社，2013．
Ministry of Health of People’s Republic of China．Analysical gualit
y specifications for routiue analyses in clinical biochemistry［S］．Beijing：Ch
in
ese Standards Publishing House，2013．
[4］Yundt-Pacheco J，Parvin CA．Validating the performance of QC procedures
［J］．Clinics in Laboratory Medicine，2013，33(1)：75-88．
[5］Parvin CA．Assessing the impact of the frequency of quality control testi
ng on the quality of reported patient results［J］．Clinical Chemistry，2008，54
(12)：2049-2054．
[6］Clinical Laboratory Standards Institute．CLSI C24：Statistical quality co
ntrol for quantitative measurement procedures：principles and defnitions［S］．W
ayne：PA，CLSI C24，2016．
[7］YAGO M，ALCOVER S．Selecting statistical procedures for quality control p
lanning based on risk management［J］．Clin Chem，2016，62(7)：959-965．
[8］BAYAT H．Selecting multi-rule quality control procedures based on patien
t risk［J］．Clin Chem Lab Med，2017，55(1)：1702-1708．
[9］WESTGARD J O， BAYAT H， WESTGARD S A．Planning risk-based SQC schedules for bracketed operation of continuous production analyzers［J］．Clinical Chemistr
y，2018，64(2)：289-296．
备注/Memo
- 备注/Memo:
-
作者简介：孔丽蕊(1972-)，女，本科，学士学位，副主任技师，研究方向：临床
生化和免疫学，E-mail：524392472@qq.com。
通讯作者：吴风(1982-)，男，本科，主管技师，研究方向：临
床生化，E-mail：804648906@qq.com。
更新日期/Last Update:
2019-02-28