Brescia Vincenzo, Varraso Lucia, Antonucci Mariantonietta, Lovero Roberto, Schirinzi Annalisa, Mascolo Elisa, Di Serio Francesca
Clinical Pathology Unit, AOU Policlinico Consorziale di Bari-Ospedale Giovanni XXIII, 70124 Bari, Italy.
Diagnostics (Basel). 2023 Mar 9;13(6):1044. doi: 10.3390/diagnostics13061044.
We evaluated and compared blood gas analysis (EGA) non-conformities (NC) considered operator-dependent performed in Point-Of-Care (POC) analyzer as quality indicators (IQ) of the pre-analytical phase. To this end, four different NC registered in the resuscitation departments of the Hospital Polyclinic Bari from the beginning of the pandemic (March 2020) until February 2022 were evaluated. The results obtained were compared with those recorded in the pre-COVID period (March 2018-February 2020) to check if there were differences in number and type.
GEM 4000 series blood gas analyzers (Instrumentation Laboratory, Bedford, MA, United States) are installed with integrated Intelligent Quality Management (iQM), which automatically identify and log pre-analytical errors. All blood gas analyzers are connected to the company intranet and interfaced with the GEM Web Plus (Werfen Instrumentation Laboratory, Bedford, MA, United States) data management information system, which allows the core laboratory to remotely supervise all decentralized POC stations. The operator-dependent process NC were expressed in terms of absolute and relative proportions (percentiles and percentage changes). For performance evaluation, the Mann-Whitney U test, Chi-squared test and Six-Sigma Metric calculation for performance classification were performed.
In the COVID period, 31,364 blood gas tests were performed vs. 16,632 tests in the pre-COVID period. The NC related to the suitability of the EGA sample and manageable by the operators were totals of 652 (3.9%) and 749 (2.4%), respectively, in the pre-COVID and COVID periods. The pre-analytical phase IQs used did not show statistically significant differences in the two periods evaluated. The Sigma evaluation did not show an increase in error rates.
Considering the increase in the number of EGAs performed in the two periods, the training procedures performed by the core laboratory staff were effective; the clinical users of the POC complied with the indications and procedures shared with the core laboratory without increasing the operator-dependent NCs. Furthermore, the core laboratory developed monitoring activities capable of guaranteeing the maintenance of the pre-analytical quality.
我们评估并比较了在即时检验（POC）分析仪上进行的、被认为取决于操作人员的血气分析（EGA）不符合项（NC），将其作为分析前阶段的质量指标（IQ）。为此，我们评估了从疫情开始（2020年3月）到2022年2月期间在巴里综合医院复苏科室记录的四种不同的NC。将获得的结果与新冠疫情前时期（2018年3月 - 2020年2月）记录的结果进行比较，以检查数量和类型是否存在差异。
GEM 4000系列血气分析仪（美国马萨诸塞州贝德福德市的Instrumentation Laboratory公司）安装了集成智能质量管理（iQM）系统，该系统可自动识别并记录分析前误差。所有血气分析仪都连接到公司内部网，并与GEM Web Plus（美国马萨诸塞州贝德福德市的Werfen Instrumentation Laboratory公司）数据管理信息系统接口，这使得核心实验室能够远程监控所有分散的POC站点。取决于操作人员的过程NC以绝对和相对比例（百分位数和百分比变化）表示。为进行性能评估，进行了曼 - 惠特尼U检验、卡方检验和用于性能分类的六西格玛指标计算。
在新冠疫情期间，共进行了31,364次血气检测，而在新冠疫情前时期为16,632次。在新冠疫情前和疫情期间，与EGA样本适用性相关且可由操作人员处理的NC总数分别为652（3.9%）和749（2.4%）。所使用的分析前阶段IQ在两个评估时期均未显示出统计学上的显著差异。西格玛评估未显示错误率增加。
考虑到两个时期进行的EGA数量增加，核心实验室工作人员执行的培训程序是有效的；POC的临床用户遵守了与核心实验室共享的指示和程序，而没有增加取决于操作人员的NC。此外，核心实验室开展了能够保证分析前质量维持的监测活动。
