A Practical Tool for Risk Management in Clinical Laboratories.

Risk management constitutes an essential component of the Quality Management System (QMS) of medical laboratories. The international medical laboratory standard for quality and competence, International Standards Organization (ISO) 15189, in its 2012 version, specified risk management for the first time. Since then, there has been much focus on this subject. We authors aimed to develop a practical tool for risk management in a clinical laboratory that contains five major cyclical steps: risk identification, quantification, prioritization, mitigation, and surveillance. The method for risk identification was based on a questionnaire that was formulated by evaluating five major components of laboratory processes, namely i) Specimen, ii) Test system, iii) Reagent, iv) Environment, and v) Testing. All risks that would be identified using the questionnaire can be quantified by calculating the risk priority number (RPN) using the tool, failure modes, and effects analysis (FMEA). Based on the calculated RPN, identified risks then shall be prioritized and mitigated. Based on our collective laboratory management experience, we authors also enlisted and scheduled a few process-specific quality assurances (QA) activities. The listed QA activities intend to monitor new risk emergence and re-emergence of those previously mitigated ones. We authors believe that templates of risk identification, risk quantification, and risk surveillance presented in this article will serve as ready references for supervisors of clinical laboratories.

First metatarsophalangeal joint fusion using a Fyxis plate.

PURPOSE: To report the outcome of fusion of the first metatarsophalangeal joint (MTPJ) using the Fyxis plate and compression screws. METHODS: Medical records of 12 men and 39 women (54 feet) aged 28 to 74 (mean, 58) years who underwent primary fusion of the first MTPJ using the Fyxis plate and compression screws for hallux rigidus (n=38), severe hallux valgus (n=8), or rheumatoid arthritis (n=8) were reviewed. The outcome measures included the fusion rate, time to fusion, complication rate, hallux valgus angle, dorsiflexion angle, and the American Orthopaedic Foot and Ankle Society (AOFAS) scale. RESULTS: The mean follow-up was 14.8 (range, 12-20) months. The mean time to fusion was 3.2 months. 48 feet achieved complete fusion at 3 months, 5 at 6 months, and one had non-union at 12 months, which was treated with revision surgery. The mean hallux valgus angle improved from 23º to 12º. The mean dorsiflexion angle improved from 22º to 23º. The mean AOFAS scale score improved from 31 to 86. 98% of the feet achieved a score of >72. One patient with non-union had a score of 59. Two feet developed superficial wound infection, which resolved with antibiotic treatment. Two other feet developed numbness over the medial aspect of the great toe, which persisted after one year. CONCLUSION: The outcome of fusion of the first MTPJ using the Fyxis plate and compression screws was good.

Scarf osteotomy with or without proximal phalangeal osteotomy for severe hallux valgus deformity.

PURPOSE: To report outcome of Scarf osteotomy with or without proximal phalangeal osteotomy for correction of severe hallux valgus deformity. METHODS: Records of 48 women and 4 men aged 28 to 68 (mean, 52) years who underwent 57 Scarf osteotomies with or without proximal phalangeal osteotomy for severe hallux valgus by a single surgeon were reviewed. The patients had a hallux valgus angle (HVA) of up to 55º. An additional proximal phalangeal osteotomy was performed in 11 of the patients whose hallux valgus persisted (HVA >10º). The American Orthopaedic Foot and Ankle Society (AOFAS) hallux score, the HVA and intermetatarsal angle (IMA) on radiographs, and the complication rate were assessed. RESULTS: The mean follow-up period was 26 (range, 24-36) months. The mean AOFAS hallux score improved from 57.4 (range, 49-64) to 91.6 (range, 75-100). The mean HVA improved from 38.1º (range, 28º-52º) to 12.8º (range, 5º-20º). The mean IMA improved from 17.0º (range, 13º-24º) to 6.8º (range, 3º-10º). One patient developed chronic regional pain syndrome. There were no instances of non-union, delayed union, or malunion of the osteotomy site. CONCLUSION: Scarf osteotomy with or without proximal phalangeal osteotomy is an effective treatment for correcting severe hallux valgus deformity.