Rao Shalinee, Masilamani Suresh, Sundaram Sandhya, Duvuru Prathiba, Swaminathan Rajendiran
Additional Professor, Department of Pathology and Laboratory Medicine, All India Institute of Medical Sciences , Rishikesh, Uttarakhand, India .
Associate Professor, Department of Pathology, Dhanalakshmi Srinivasan Medical College , Perambalur, Tamil nadu, India .
J Clin Diagn Res. 2016 Jan;10(1):EC07-11. doi: 10.7860/JCDR/2016/14546.7087. Epub 2016 Jan 1.
Quality monitoring in histopathology unit is categorized into three phases, pre-analytical, analytical and post-analytical, to cover various steps in the entire test cycle. Review of literature on quality evaluation studies pertaining to histopathology revealed that earlier reports were mainly focused on analytical aspects with limited studies on assessment of pre-analytical phase. Pre-analytical phase encompasses several processing steps and handling of specimen/sample by multiple individuals, thus allowing enough scope for errors. Due to its critical nature and limited studies in the past to assess quality in pre-analytical phase, it deserves more attention.
This study was undertaken to analyse and assess the quality parameters in pre-analytical phase in a histopathology laboratory.
This was a retrospective study done on pre-analytical parameters in histopathology laboratory of a tertiary care centre on 18,626 tissue specimens received in 34 months. Registers and records were checked for efficiency and errors for pre-analytical quality variables: specimen identification, specimen in appropriate fixatives, lost specimens, daily internal quality control performance on staining, performance in inter-laboratory quality assessment program {External quality assurance program (EQAS)} and evaluation of internal non-conformities (NC) for other errors.
The study revealed incorrect specimen labelling in 0.04%, 0.01% and 0.01% in 2007, 2008 and 2009 respectively. About 0.04%, 0.07% and 0.18% specimens were not sent in fixatives in 2007, 2008 and 2009 respectively. There was no incidence of specimen lost. A total of 113 non-conformities were identified out of which 92.9% belonged to the pre-analytical phase. The predominant NC (any deviation from normal standard which may generate an error and result in compromising with quality standards) identified was wrong labelling of slides. Performance in EQAS for pre-analytical phase was satisfactory in 6 of 9 cycles.
A low incidence of errors in pre-analytical phase implies that a satisfactory level of quality standards was being practiced with still scope for improvement.
组织病理学部门的质量监测分为三个阶段，即分析前、分析中和分析后，以涵盖整个检测周期的各个步骤。对有关组织病理学质量评估研究的文献综述表明，早期报告主要集中在分析方面，而对分析前阶段评估的研究有限。分析前阶段包括多个处理步骤以及多个人员对标本/样品的处理，因此存在足够的出错空间。由于其关键性质以及过去对分析前阶段质量评估的研究有限，它值得更多关注。
本研究旨在分析和评估组织病理学实验室分析前阶段的质量参数。
这是一项对一家三级护理中心组织病理学实验室在34个月内接收的18626份组织标本的分析前参数进行的回顾性研究。检查登记册和记录，以了解分析前质量变量的效率和错误情况：标本识别、标本置于适当固定剂中、丢失标本、染色的日常内部质量控制表现、实验室间质量评估计划（外部质量保证计划（EQAS））中的表现以及对其他错误的内部不符合项（NC）评估。
研究显示，2007年、2008年和2009年标本标签错误率分别为0.04%、0.01%和0.01%。2007年、2008年和2009年分别有0.04%、0.07%和0.18%的标本未用固定剂送检。没有标本丢失的情况。共识别出113项不符合项，其中92.9%属于分析前阶段。识别出的主要不符合项（任何偏离正常标准可能产生错误并导致质量标准受损的情况）是玻片标签错误。在9个周期中的6个周期，分析前阶段的EQAS表现令人满意。
分析前阶段的低错误发生率意味着质量标准的实施水平令人满意，但仍有改进空间。
