• Korean Journal of Clinical Laboratory Science
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• v.48 no.2
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• pp.158-167
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• 2016

The requirements for medical laboratories ISO 15189 is examined in organization and a quality management system, stressing the importance of evidence, document control, and control of records and clinical material. Medical services are provided from the areas of resource management, and pre-examination, examination and post-examination processes. The main goal of ISO 15189 accreditation is to improve the quality of laboratory services provided for patients and clinical users not only through compliance with consensually developed and harmonized requirements but also by adopting the philosophy of continual improvement using the Plan-Do-Check-Act cycle. Laboratory quality should be evaluated and improved in all steps of the testing process as the state-of-the art indicates that the pre- and post-analytical phases are more vulnerable to errors than the intra-analytical phase. The Korea Laboratory Accreditation Scheme (KOLAS), a national accreditation body, provides medical laboratory accreditations for appropriate approaches to evaluating the competence of a medical laboratory in providing effective services to its customers and clinical users. Adoption of ISO 15189 in 2010s as a government policy has been delayed, and only 5 laboratories have been accredited to date in Korea. The medical laboratories should seek the adoption of ISO 15189 with a positive attitude for quality improvement and strengthening of international competitiveness.

• The Korean Journal of Nuclear Medicine Technology
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• v.14 no.1
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• pp.94-100
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• 2010

Purpose: We can evaluate function of kidney by Glomerular Filtration Rate (GFR) test using $^{99m}Tc$-DTPA which is simple. This test is influenced by several parameter such as net syringe count, kidney depth, corrected kidney count, acquisition time and characters of gamma camera. In this study, we evaluated predose count according to matrix size in the GFR test using $^{99m}Tc$-DTPA. Materials and Methods: Gamma camera of Infinia in GE was used, and LEGP collimator, three types of matrix size ($64{\times}64$, $128{\times}128$, $256{\times}256$) and 1.0 of zoom factor were applied. We increased radioactivity concentration from 222 (6), 296 (8), 370 (10), 444 (12) up to 518 MBq (14 mCi) respectively and acquired images according to matrix size at 30 cm distance from detector. Lastly, we evaluated these values and then substituted them for GFR formula. Results: In $64{\times}64$, $128{\times}128$ and $256{\times}256$ of matrix size, counts per second was 26.8, 34.5, 41.5, 49.1 and 55.3 kcps, 25.3, 33.4, 41.0, 48.4 and 54.3 kcps and 25.5, 33.7, 40.8, 48.1 and 54.7 kcps respectively. Total counts for 5 second were 134, 172, 208, 245 and 276 kcounts from $64{\times}64$, 127, 172, 205, 242, 271 kcounts from $128{\times}128$, and 137, 168, 204, 240 and 273 kcounts from $256{\times}256$, and total counts for 60 seconds were 1,503, 1,866, 2,093, 2,280, 2,321 kcounts, 1,511, 1,994, 2,453, 2,890 and 3,244 kcounts, and 1,524, 2,011, 2,439, 2,869 and 3,268 kcounts respectively. It is different from 0 to 30.02 % of percentage difference in $64{\times}64$ of matrix size. But in $128{\times}128$ and $256{\times}256$, it is showed 0.60 and 0.69 % of maximum value each. GFR of percentage difference in $64{\times}64$ represented 6.77% of 222 MBq (6 mCi), 42.89 % of 518 MBq (14 mCi) at 60 seconds respectively. However it is represented 0.60 and 0.63 % each in $128{\times}128$ and $256{\times}256$. Conclusion: There was no big difference in total counts of percentage difference and GFR values acquiring from $128{\times}128$ and $256{\times}256$ of matrix size. But in $64{\times}64$ of matrix size when the total count exceeded 1,500 kcounts, the overflow phenomenon was appeared differently according to predose radioactivity of concentration and acquisition time. Therefore, we must optimize matrix size and net syringe count considering the total count of predose to get accurate GFR results.

• The Korean Journal of Nuclear Medicine Technology
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• v.18 no.1
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• pp.43-48
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• 2014

Purpose: In the PET/CT images, The SUV (standardized uptake value) enables the quantitative assessment according to the biological changes of organs as the index of distinction whether lesion is malignant or not. Therefore, It is too important to enter parameters correctly that affect to the SUV. The purpose of this study is to evaluate an allowable error range of SUV as measuring the difference of results according to input errors of Activity, Weight, uptake Time among the parameters. Materials and Methods: Three inserts, Hot, Teflon and Air, were situated in the 1994 NEMA Phantom. Phantom was filled with 27.3 MBq/mL of 18F-FDG. The ratio of hotspot area activity to background area activity was regulated as 4:1. After scanning, Image was re-reconstructed after incurring input errors in Activity, Weight, uptake Time parameters as ${\pm}5%$, 10%, 15%, 30%, 50% from original data. ROIs (region of interests) were set one in the each insert areas and four in the background areas. $SUV_{mean}$ and percentage differences were calculated and compared in each areas. Results: $SUV_{mean}$ of Hot. Teflon, Air and BKG (Background) areas of original images were 4.5, 0.02. 0.1 and 1.0. The min and max value of $SUV_{mean}$ according to change of Activity error were 3.0 and 9.0 in Hot, 0.01 and 0.04 in Teflon, 0.1 and 0.3 in Air, 0.6 and 2.0 in BKG areas. And percentage differences were equally from -33% to 100%. In case of Weight error showed $SUV_{mean}$ as 2.2 and 6.7 in Hot, 0.01 and 0.03 in Tefron, 0.09 and 0.28 in Air, 0.5 and 1.5 in BKG areas. And percentage differences were equally from -50% to 50% except Teflon area's percentage deference that was from -50% to 52%. In case of uptake Time error showed $SUV_{mean}$ as 3.8 and 5.3 in Hot, 0.01 and 0.02 in Teflon, 0.1 and 0.2 in Air, 0.8 and 1.2 in BKG areas. And percentage differences were equally from 17% to -14% in Hot and BKG areas. Teflon area's percentage difference was from -50% to 52% and Air area's one was from -12% to 20%. Conclusion: As shown in the results, It was applied within ${\pm}5%$ of Activity and Weight errors if the allowable error range was configured within 5%. So, The calibration of dose calibrator and weighing machine has to conduct within ${\pm}5%$ error range because they can affect to Activity and Weight rates. In case of Time error, it showed separate error ranges according to the type of inserts. It showed within 5% error when Hot and BKG areas error were within ${\pm}15%$. So we have to consider each time errors if we use more than two clocks included scanner's one during the examinations.