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INTRODUCTION: Pathology laboratories are increasingly seeking accreditation to quality standards to assure Quality of Service (QoS). However, there is little data available regarding the value of this in laboratories with well-established Quality Management Systems (QMS). Moreover, critics of accreditation claim it redirects resources toward trivial issues. Our objective was to investigate the value of auditing for conformity with the ISO 15189:2012 standard in such laboratories. DESIGN: and Methods: In total, 483 Audit-Identified Non-Conformities (AINCs) were documented within our department since transitioning to an ISO 15189:2012 compliant QMS. The potential consequences of these were assessed by three clinical laboratorians who assigned them into categories based on their likely impact. These were: Unlikely (no clear consequences); Possible (potential for poor QoS/harm); and Probable (Likely to cause poor QoS/harm). Additionally, total numbers/severity of Real-Time Non-Conformities (RTNCs) detected outside of auditing were examined to provide additional insight into the effects of accreditation on QoS. RESULTS: According to majority decision: 395 (81.8%) of AINCs were classified Unlikely, 88 (18.2%) were Possible, and none were Probable. The relative proportion of Unlikely AINCs also rose over time. Total numbers and severity of RTNCs dropped in the short-term following transition to an ISO 15189:2012 QMS, but steadily rose thereafter. CONCLUSIONS: Our data suggest auditing for conformity with ISO 15189:2012 standards may be effective in attaining accreditation, but may have diminishing returns in the long-term once the QMS is established, unless there is continual improvement in the audit process to promote better use of resources.
RESUMEN
This article for the first time reports a large set of monitoring results for formaldehyde exposure during grossing activities in health care anatomic pathology laboratories, and compares the effectiveness of different local exhaust ventilation systems on the exposure. To control the confounding effects from grossing work load, sampling duration, and the sizes of specimens grossed, only 15-min short-term personal exposure samples collected during large tissue specimen grossing were used for the comparison of the effectiveness of these local exhaust systems. While we also collected long-term 8-hr time weighted average samples, these are not treated in this analysis. The systems examined were canopy receiving hoods, slot exhausts, and commercially available pre-manufactured backdraft grossing stations, both recirculating and ducted exhaust types. Out of over 2,000 personal short-term air samples, 307 samples from 163 surveys met the data selection criteria. Over a third of the data were less than the analytical laboratory limits of detection. Using the robust maximum likelihood estimation method for multiple limits of detection, the mean and geometric mean of the dataset for each type of local exhaust system were found to be less than the short-term personal exposure regulatory limit of 2 ppm. Nonparametric Wilcoxon rank-sum pairwise tests of five types of engineering controls showed a statistically significant difference among these controls, with the most effective being the manufactured backdraft grossing stations ducted to the outside, and the least effective being canopy exhaust systems and manufactured filtered recirculating grossing stations. Finally, exposure with each of the major engineering control types was rated by the American Industrial Hygiene Association exposure control rating scheme.