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Strategic Planning to Establish Quality System in Medical Laboratory
Z Rahmani, S Royani, Ar Ahmadi,
Volume 7, Issue 1 (4-2013)
Abstract
Abstract Background and Objective: Every organization requires ongoing evaluation of existing conditions. The purpose of this study is to assess and analyze the standards and criteria that each Laboratory system is required to observe and upgrade them, to determine the gap between the ideal and the current status and finally to present the strategy and executive plan in order to achieve the desirable status. Material and Methods: This study was performed in a medical diagnostic laboratory in Gorgan by using the quality system checklist related to medical diagnostic laboratories, which was revised in 2009. Internal evaluation matrix (Internal Factor Evaluation) was used to examine the main factors in the context of establishing a quality management system in a clinical laboratory.After examining the factors, determining the laboratory status, recording the results of monitoring (in terms of strengths and weaknesses) and determining the gap between existing and desirable status, we provided the appropriate and effective solutions in line with defined standard. Results: of 164 items thatshould have been done in the first assessment, 111 (67.7%) items are in performed group and 53 (32.3%) are not in. After compiling and running a plan, 147 (89.6%) are performed, 15 (9.2%) needed to be modified and 2 (1.2%) still not performed. It is evident that a significant difference (p< 0.05) and a tangible improvement in current problems are seen after establishing the qualitysystem in the laboratory. The lab equipment, lab space and facilities, pre-examination process, testing process and post-examination process are considered .Regarding the health and safety in the laboratory, lab equipment, lab space and facilities, pre-examination process, testing process and post-examination process, no significant difference is observed between before and after the implementation of the program. Conclusion:after establishing the quality system in laboratory, a significant difference and tangible improvement in the current problems are observed. It is implied the importance of pre-planned responses to problems and the performance of strategic planning. Keywords: Strategic Planning, Medical Diagnostic Laboratory, Quality Control
Effect of ISO 9001-2008 in Reducing the Number of Repeated Tests in Medical Diagnostic Laboratories
Royani, S, Ravaghi, H, Ahmadi, Ar, Vafaeian, Z. ,
Volume 9, Issue 3 (9-2015)
Abstract

Abstract

Background and Objective: One of the organizations that have proceeded for very high standard quality management programs, ISO 9001-2008, is medical diagnostic laboratories. One of the important goals of most laboratories in the implementation of this standard is to reduce the current costs of repeated tests.

Material and Methods: The number of repeated tests was evaluated in biochemistry section (Glucose, Urea, Creatinine, Cholesterol, Triglycerides, AST and ALT) and hormones (T3, T4, and TSH) in three stages (pre-standard implementation, three and nine months after performing program).  We analyze the data by Stat data software (version 8) using Pearson chi square test.

Results: The percentages of repeated tests for glucose, urea, creatinine, cholesterol, triglycerides, AST, ALT, T3, T4, TSH were 16.5, 2.57, 2.88, 12.7, 14.9, 10.38, 12.6, 3.55, 4.69, 1.85 for the first time  and 20.5, 5.56, 5.41, 7.25, 20.0, 27.2, 30.1, 0.3, 6.04, 3.08 for the second time and 8, 8.3, 9.2, 7.1, 12.8, 17.4, 19.5, 0.0, 5.81,1.01 for the third time, respectively. The changes in statistical analysis of urea, creatinine, cholesterol, AST, ALT, and TSH were significant. The percentage trend of repeated tests for urea and creatinine was increased while for TSH, it was decreased.

Conclusion: Due to the nature of the experiments and the principles governing repeated tests, the acceptance and implementation of the ISO 9001-2008 only to reduce costs by reducing the percentage of repeated tests cannot be  justified. To implement this process, all aspects of the effectiveness should be considered together.

Keywords: ISO 9001-2008, Medical Diagnostic Laboratory, Effectiveness, Cost Reduction.


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