Leucine-rich alpha-2 glycoprotein as a marker of mucosal healing in inflammatory bowel disease.

Leucine-rich alpha-2 glycoprotein (LRG) may be a novel serum biomarker for patients with inflammatory bowel disease. The association of LRG with the endoscopic activity and predictability of mucosal healing (MH) was determined and compared with those of C-reactive protein (CRP) and fecal markers (fecal immunochemical test [FIT] and fecal calprotectin [Fcal]) in 166 ulcerative colitis (UC) and 56 Crohn's disease (CD) patients. In UC, LRG was correlated with the endoscopic activity and could predict MH, but the performance was not superior to that of fecal markers (areas under the curve [AUCs] for predicting MH: LRG: 0.61, CRP: 0.59, FIT: 0.75, and Fcal: 0.72). In CD, the performance of LRG was equivalent to that of CRP and Fcal (AUCs for predicting MH: LRG: 0.82, CRP: 0.82, FIT: 0.70, and Fcal: 0.88). LRG was able to discriminate patients with MH from those with endoscopic activity among UC and CD patients with normal CRP levels. LRG was associated with endoscopic activity and could predict MH in both UC and CD patients. It may be particularly useful in CD.

[Quality management of medical laboratory--a survey for National University Hospital].

Since ISO (International Organization for Standardization) 15189 for medical laboratories was established in Japan in 2003, 60 medical laboratories had been certified until April 2011. Among them, 10 medical laboratories belong to national university hospitals. To investigate the current status for the development of a quality management system, we carried out a questionnaire survey targeting all national university hospitals. ISO and ISO 15189 have already been introduced in about 70% of all laboratories and 53% are ready to accept them. In medical laboratories that have already accepted ISO 15189, it was suggested that their quality management systems have been functioning effectively and a gradual decrease of the number of the incidents has been confirmed.

[Effect of ISO15189 accreditation on Okayama University Hospital].

The evaluation of medical laboratories by a third person has recently become popular in Japan. Establishing a quality management system, putting it into practice, and maintaining and improving it are considered to achieve the standardization, efficacy improvement, and safety management of laboratory activities. The Departments of Clinical Laboratory and Blood Transfusion, Okayama University Hospital was awarded ISO15189 accreditation on July 6, 2007. In this paper, we describe the process of ISO15189 accreditation in our institute. As an outcome of ISO accreditation, the frequency of laboratory incidents was reduced through seeking the causes of incidents and performing continual improvement according to ISO 15189: "Plan, Do, Check, Action". Additionally the motivation and competence of laboratory staff concerned have also improved, consequently leading to a favorable influence on other laboratory staff members. Therefore, we conclude that ISO15189 is an effective tool for medical laboratory management.