Ultrasound Imaging of Subtalar Joint Instability for Chronic Ankle Instability.

The purpose of this study was to develop the assessment of subtalar joint instability with chronic ankle instability (CAI) using ultrasonography. Forty-six patients with anterior talofibular ligament (ATFL) abnormalities and a history of ankle sprain were divided into CAI (21.2 ± 5.9 y/o, 7 males and 17 females) and asymptomatic groups (21.0 ± 7.4 y/o, 9 males and 12 females) on the basis of subjective ankle instability assessed using the CAIT and the Ankle Instability Instrument Tool (AIIT). Twenty-six age-matched feet participated in a control group (18.9 ± 7.0 y/o, 9 males and 17 females). Ultrasound measurements of the width of the posterior subtalar joint facet were obtained at rest and maximum ankle inversion (subtalar joint excursion; STJE). The differences in STJE among the three groups were assessed by one-way ANOVA. The relationship between STJE and subjective ankle instability was assessed using Spearman's correlation tests. The STJE value was significantly greater in the CAI group (2.3 ± 0.8 mm) than in the asymptomatic (1.0 ±0.4 mm) and control groups (0.8 ±0.2 mm) (p < 0.001, effect size: 0.64). STJE had significant negative correlations with CAIT (r = -0.71, p < 0.01), and significant positive correlations with AIIT (r = 0.74, p < 0.01). The cut-off value to distinguish between the CAI and asymptomatic groups was 1.7 mm using the ROC curve.

[Validation of the ISO 15189 trial assessment results of clinical laboratories--effects of accreditation and interpretation of ISO 15189].

Japanese Committee for Clinical Laboratory Standards (JCCLS) and the Japan Accreditation Board for Conformity Assessment (JAB) have developed an accreditation program for clinical laboratories using ISO 15189 in Japan. On October 1, 2004, twelve clinical laboratories applied for trial accreditation assessment. Seven laboratories were selected, including a university hospital laboratory, two other hospital-based laboratories, three large private clinical laboratories and an other private clinical laboratory. JAB had given a one week-training course to the candidate technical assessors who were nominated from the Japanese Society of Laboratory Medicine (JSLM) and the Japanese Association of Medical Technologists (JAMT), and candidate system assessors who were nominated from JAB. Thirty-five members had successfully passed the examination. During the period from November 2004 to May 2005, five laboratories were visited for assessment by four to six assessors for two or three days. Final assessment reports were discussed by the program developing committee for the validation of the accreditation program. The conclusions were that the program did not have any critical problems, but the assessment visit would have been more efficient if JAB published an easily understandable guidance document on ISO 15189, and had some training courses for laboratories in Japan in order to understand ISO 15189 more deeply. In addition, JAB should develop a more simplified checklist, mainly describing the important requirements. JAB formally started the clinical laboratory accreditation scheme from August 1, 2005 and five laboratories were accredited by the newly started accreditation committee on August 31, 2005, and four laboratories were additionally accredited on November 28, 2005. The most difficult clauses in ISO 15189:2003 were 5.6.2 and 5.6.3 on uncertainty and traceability, and 5.7.1 on post-examination procedures. Some difficult clauses to understand in the International Standard were discussed.

[ISO 15189 medical laboratory accreditation].

This International Standard, based upon ISO/IEC 17025 and ISO 9001, provides requirements for competence and quality that are particular to medical laboratories. While this International Standard is intended for use throughout the currently recognized disciplines of medical laboratory services, those working in other services and disciplines will also find it useful and appropriate. In addition, bodies engaged in the recognition of the competence of medical laboratories will be able to use this International Standard as the basis for their activities. The Japan Accreditation Board for Conformity Assessment (AB) and the Japanese Committee for Clinical Laboratory Standards (CCLS) are jointly developing the program of accreditation of medical laboratories. ISO 15189 requirements consist of two parts, one is management requirements and the other is technical requirements. The former includes the requirements of all parts of ISO 9001, moreover it includes the requirement of conformity assessment body, for example, impartiality and independence from any other party. The latter includes the requirements of laboratory competence (e.g. personnel, facility, instrument, and examination methods), moreover it requires that laboratories shall participate proficiency testing(s) and laboratories' examination results shall have traceability of measurements and implement uncertainty of measurement. Implementation of ISO 15189 will result in a significant improvement in medical laboratories management system and their technical competence. The accreditation of medical laboratory will improve medical laboratory service and be useful for patients.