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1 Journal of the Korea Academia-Industrial cooperation Society Vol. 20, No. 2 pp , ISSN / eissn 김혜정경운대학교임상병리학과 Analysis of Relevant Factors and External Quality Assessment in Small-Medium Sized Hospital Hye-Jeong Kim Division of Biomedical Laboratory Science, Kyungwoon University 요약국내의료기관은임상검사의질향상을위하여외부정도관리를시행하고있으나일차의료기관의경우기관장의인식부족및비용에대한부담으로미시행하고있는실정이다. 본연구는중소의료기관을대상으로임상화학분야외부정도관리를시행하고종합병원이상의의료기관외부정도관리결과와비교해보며, 정도관리에영향을주는관련요인에대하여분석해보았다. 중소의료기관을대상으로 3년간년 1회임상화학분야 21개종목의외부정도관리를실시하고항목별분석방법, 변이계수, 의료기관의특성에따른이상치를분석하였다. 검사항목별분석방법및변이계수는 3년간특이적변화는보이지않았으며, 중소의료기관은임상화학검사의분석방법이다양하고변이계수가높게나타났다. 정도관리에영향을주는이상치 (poor value) 와같은오류발생은외부정도관리를실시하지않을수록 (p 0.05), 내부정도관리의주기가매일이루어지지않을수록 (p 0.01), 검사량이적은의료기관일수록 (p 0.01) 많이발생하는것으로유의하게나타났다. 중소의료기관의외부정도관리에대한인식개선과중소의료기관종사자를위한맞춤식교육이필요하다하겠다. Abstract Korean hospitals implement external quality assessment (EQA) schemes to improve the quality of clinical tests. However, smaller hospital do not implement EQA due to lack of appreciation and cost burdens. The purpose of this study was to analyze the results of EQA from the perspective of clinical chemistry carried out at a small-to-medium sized hospital (SMH) and to investigate factors influencing quality control. The medical institution concerned had performed EQA on 21 items annually for three years and had analyzed measurement s, variation coefficients, and anomalous results as defined by the SMH. No significant change in test s or variation coefficients, which exhibited a high level of variation, were observed for any test item over the 3-year period. The results obtained showed that anomalous test results were significantly more frequent when EQA was not conducted (p 0.05), internal quality control was not conducted daily (p 0.01), and when tests were less frequently performed (p 0.01). Small-to-medium sized hospitals need to be more aware of the benefits of EQA and provide tailored education to staff. Keywords : Chemistry, External Quality Assessment, Hospital, Quality Control, Variation Coefficient 1. 서론 정도관리 (quality control: QC) 의목적은검사의모든과정에서발생할수있는오류의원인을조기감지하고 예방하여환자검사결과에대한타당성을증가시켜신뢰성있는검사결과치를제공하고자함이다. 산업계에서사용되던정도관리의이론과방법이 1950년에 Levey와 Jennings에의해검사실에도입된후, 정도관리 * Corresponding Author : Hye-Jeong Kim(Kyungwoon Univ.) Tel: hjkim11@ikw.ac.kr Received October 26, 2018 Revised (1st November 13, 2nd November 21, 2018) Accepted February 1, 2019 Published February 28,

2 는임상검사실에서점차그중요성이강조되어왔다 [1-3]. 외부정도관리는공인된기관을통하여검사실의정확도를간접적으로확인할수있는방법으로 [4] 내부정도관리에서알아낼수없는문제점을파악할수있고다른검사실, 혹은표준검사법과의비교를통해서검사실의결과를평가할수있다는장점이있다 [5]. 국내에서는외부정도관리를위하여대한임상검사정도관리협회 [6], CAP (college of American Pathologists) survey (USA)[7], AQuAS (Asian Quality Assurance Survey Program)[8], NEQAS (UK)[9] 등의프로그램이사용되고있다. 외부정도관리프로그램에참여하여검사의정확도및재현도를확인하는것이중요하기 [10] 때문에많은검사실에서대한임상검사정도관리협회에서실시하는외부정도관리프로그램에가입하여참여하고있다. 대한임상검사정도관리협회는국내임상검사의질향상을위하여 2016년부터외부정도관리신빙도조사사업을전면시행하고있으나일차의료기관의경우기관장의인식부족및비용에대한부담으로미시행하고있는실정이다. 본연구는중소의료기관을대상으로임상화학분야외부정도관리를시행하고결과를피드백함으로써외부정도관리의중요성에대한인식을높이고자하였으며, 3년간외부정도관리사업결과를분석해보고정도관리에영향을주는요인에대하여조사해보고자한다. 2. 재료및방법 2.1 대상대한임상병리사협회일개도회의의료기관을대상으로년 1회 3년간 (2016년 ~ 2018년 ) 외부정도관리를시행하였다. 도회의외부정도관리사업에참여하고자하는의료기관을대상으로매년신청을받아실시하였다. 종합병원, 병원, 의원으로병원종별을표기하게하였으며, 병원과의원이매년 80% 이상을차지하였다 (Table 1). 정도관리물질은일반화학 2종을특수제작한용기에넣고냉장보관하여일괄적으로한번에발송하고기한내에결과지와설문지를메일로회신하도록하였다. 도회외부정도관리사업에참여를신청하였으나기한내검사결과및설문문항을회신하지않은의료기관은대상에서제외시켰다. Table 1. Control material provided for analysis and number of participating laboratories from 2016 to 2018 Sample No. Manufacturer Lot No Wako Control Bio-Rad Control Bio-Rad Control EQ035 EQ N of Participating Labs Class of Labs ),37 2),31 3) ),30 2),24 3) ),28 2), 28 3) Bio-Rad: Liquid Assayed Multiqual Control (Bio-Rad Laboratories Inc., CA, USA). Wako: Wako Control Serum (Wako Pure Chemica Ltd., Osaka, USA). 1) General hospital; 2) Hospital; 3) Clinic. Table 2. Reference values according to the major s used in clinical chemistry test Item Method reference value unit BUN Urease with GLDH 13.1~17.1 mg /dl Creatinine Jaffe reaction 0.58~1.05 mg /dl Glucose GOD (colorimetric) 47.2~61.5 mg /dl T-Calcium OCPC 5.5~6.8 mg /dl Phosphorous Phosphomolybdate, UV 1.61~2.19 mg /dl Uric Acid Uricase 2.9~3.9 mg /dl T-Bilirubin Diazonium salt 0.36~0.7 mg /dl Protein Biuret 3.6~4.4 g/dl Albumin Dye binding-bcg 2.2~2.8 g/dl T-Cholesterol Enzymatic 96.9~119 mg /dl Triglyceride Enzymatic 81.9~108 mg /dl AST (GOT) UV Rate 33.6~46.8 U/L ALT (GPT) UV Rate 21.9~38.3 U/L P-NPP 23.5~47.9 U/L ALP Sekisui Medical Pureauto S 97.0~137 U/L Enzymatic 97.1~138 U/L LDH Sekisui Medical Pureauto S LD-P 257~317 U/L GGT IFCC 20.9~34.8 U/L HDL-C Sekisui HDL direct 22.0~36.0 mg /dl LDL-C Sekisui LDL direct 57.0~71.0 mg /dl Sodium ISE 103~123 meq/l Potassium ISE 2.4~3.0 meq/l Chloride ISE 67.0~79.0 meq/l Bio-Rad Liquid Assayed Multiqual Control. Abbreviations: BUN, blood urea nitrogen; GLDH, glutamate dehydrogenase; GOD, glucose oxidase; T-Calcium, total calcium; OCPC, o-cresolphthalein complexone; UV, ultra violet; T-Bilirubin, total bilirubin; BCG, bromocresol green; T-cholesterol, total cholesterol; AST, aspartate aminotransferase; ALT, alanine transaminase; ALP, alkaline phosphatase; P-NPP, para nitrophenylphosphate; LDH, lactate dehydrogenase; GGT, gamma glutamyl transferase; IFCC, International Federation of Clinical chemistry; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; ISE, ion-selective electrodes. 295

3 한국산학기술학회논문지제 20 권제 2 호, 정도관리물질과검사종목일반화학정도관리물질은 BioRad 사의 Liquid Assayed Multiqual Control (Bio-Rad Laboratories Inc., CA, USA) 및 Wako사의 Wako Control Serum(Wako Pure Chemica Ltd., Osaka, USA) 제품을사용하였다 (Table 1). BioRad사에서제공하는 Liquid Assayed Multiqual Control 시약에대한검사종목별참고치를 Table 2에정리하였다. 검사종목은 BUN, Creatinine, Glucose 등 21 종목 (Table 2) 으로각의료기관에서분석하여결과및분석방법을입력하도록하였다. 2.3 설문조사설문지의조사내용은각의료기관의규모, 외부정도관리시행여부, 검진기관의여부, 내부정도관리시행주기, 하루검체량, 요구사항등을입력하도록하였다. 2.4 통계분석 3년간의검사항목별의료기관에서사용하고있는분석방법의추이및변이계수를분석하였다. 전체의료기관의평균 ±2표준편차를벗어나는값을이상치 (poor value) 로칭하고 2018년참여의료기관의 poor value의개수와관련성있는요인을알아보기위하여 t-test, ANOVA test 및상관분석을실시하였다. 통계분석은 SPSS version 13.0 (SPSS Inc., Chicago, IL, USA), Microsoft Excel 2016 (Microsoft, Seattle, WA, USA) 을사용하였으며 p값이 0.05 미만인경우통계적으로유의한것으로판정하였다. 요인으로외부정도관리시행여부, 내부정도관리의주기, 검진기관의여부, 의료기관의종별및검사실의일일검체수로정하고이상치 (poor value) 와의관련성을분석하였다. 3. 결과 3.1 일반화학검사항목별분석방법의분포검사항목별주요분석방법의분포를 Table 3에정리하였다. 3년동안측정종목에서한가지의원리가전체의 80% 를넘는항목을살펴보면 BUN (blood urea nitrogen) 은 urease with glutamate dehydrogenase법을, Creatinine은 Jaffe법을, Uric Acid는 uricase를이용한비색법을, Protein은 Biuret법을, Albumin은 BCG법을, T-Cholesterol 및 Triglyceride는효소법을사용하고있는것으로나타났다. T-Calcium, HDL-콜레스테롤및, LDL-콜레스테롤검사는다양한검사방법을사용하고있었다. Table 3. Analytical s used in clinical chemistry from 2016 to 2018 Years(%) Item Method Urease with GLDH Urease Quinolinium dye BUN 1.3 (Vitros) Other Creatinine Glucose T-Calcium Phosphorous Uric Acid T-Bilirubin Protein Albumin T-Cholesterol Triglyceride AST (GOT) ALT (GPT) ALP LDH GGT Jaffe reaction Enzymatic Other GOD(colorimetric) Hexokinase, UV Other ARSENAZO Ⅲ Cresolphthalein complexone (OCPC) Other Phosphomolybdate, UV Other Uricase Other Diazonium salt Oxidation Vanadate oxidation Other Biuret Other Dye binding-bcg Other Enzymatic Other Enzymatic Other UV Rate Enzymatic Other UV Rate Other P-NPP Other Lactate to pyruvate Pyruvate to lactate Other GGCNA (IFCC) GGPNA Other

4 Item HDL-C LDL-C Sodium Potassium Chloride Method Years Homogeneous Direct Enzymatic Roche HDL direct Sekisui HDL direct Wako HDL direct Other Roche LDL direct Sekisui LDL direct Wako LDL direct Other ISE Other ISE Other ISE Other Abbreviations: BUN, blood urea nitrogen; GLDH, glutamate dehydrogenase; GOD, glucose oxidase; UV, ultra violet; T-Calcium, total calcium; OCPC, o-cresolphthalein complexone; T-Bilirubin, total bilirubin; BCG, bromocresol green; T-cholesterol, total cholesterol; AST, aspartate aminotransferase; ALT, alanine transaminase; ALP, alkaline phosphatase; P-NPP, para nitrophenylphosphate; LDH, lactate dehydrogenase; GGT, gamma glutamyl transferase; GGCNA, gammaglutamyl carboxy nitroanilide; IFCC, International Federation of Clinical chemistry; GGPNA, gamma glutamyl p-nitroanilide; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; ISE, ion-selective electrodes. 3.2 검사항목별변이계수의변화 2종 ( 정상물질, 비정상물질 ) 의정도관리물질에대한일반화학검사를실시하고검사항목별전체의료기관의변이계수를 Table 4에정리하였다. 대부분의검사항목변이계수는선택변이계수보다낮은수치를나타내었으나, BUN, Creatinine, T-Calcium, Protein, ALP, LDH, Chloride는높은수치를보였다. 변이계수가 10% 를넘은항목은 Creatinine, T-Bilirubin, ALP, LDH, HDL-C, LDL-C 로나타났다. 정도관리시약별로 3년간의변이계수추이는정상정도관리시약의변이계수는다소증가를보였으나, 비정상정도관리시약의변이계수는감소추세를나타내었다. Table 4. Annual changes in CVs according to the test from 2016 to 2018 Normal Item CCV control Abnormal control BUN Creatinine Glucose T-Calcium Phosphorous Uric Acid T-Bilirubin Protein Albumin T-Cholesterol Triglyceride AST (GOT) ALT (GPT) ALP LDH GGT HDL-C LDL-C Sodium Potassium Chloride Abbreviations: CV, coefficient of variation (SD/Mean); CCV, chosen coefficient of variation. 3.3 의료기관의특성에따른이상치의분석전체참여기관의검사결과를각검사항목별로평균 ±2 표준편차를구하고, 그벗어나는값을이상치 (poor value) 로칭하였다. 각의료기관의이상치의개수와관련성있는요인을분석하여 Table 5에정리하였다. 외부정도관리를시행하고있지않은기관이 42개기관으로시행하고있는의료기관보다이상치의개수가유의하게높은것으로나타났다 (p 0.05). 내부정도관리시행주기가한달에몇번시행하는기관이매일실시하는의료기관보다이상치의개수가유의하게높은것으로나타났다 (p 0.01). 건겅검진의료기관이비건강검진기관보다이상치의개수가낮았으나유의하지는않았다. 병원의종별에따라종합병원, 병원, 의원으로구분하였으며종합병원의경우병원및의원에비해이상치의개수가낮았으나유의하지는않았다. 의료기관이하루에검사하는검체의수와이상치개수와의상관분석을실시한결과, 하루검체량이적을수록이상치의수가유의하게많은것으로나타났다 (p 0.01)(Table 6). 297

5 한국산학기술학회논문지제 20 권제 2 호, 2019 Table 5. Relativity analysis of number of the poor value according to quality management test, medical check up and class of hospital in 2018 N of poor N of values hospital (Mean±SD) Check of Yes ±1.1 EQA test 1) No ±2.6 per day ±1.4 Period of IQA test 2) per week ±1.3 per month ±7.6 Check of Yes ±1.4 MCH 3) No ±4.5 General h ±1.1 Class of hospital 4) Hospital ±3.2 Clinic ±1.2 p- values 0.041* 0.004** Abbreviations: EQA, external quality assessment; IQA, internal quality assessment; MCH, medical check up hospital. 1) * p value less than 0.05 is significance level by t-test. 2) ** p value less than 0.01 is significance level by ANOVA-test. 3) p value is non significance level by t-test. 4) p value is non significance level by ANOVA-test. Table 6. Correlational analysis of number of the chemistry samples tested per day and poor value N of poor value N of chemistry samples tested per day ** r(correlation coefficient) = ** p value less than 0.01 is significance level by CA-test. 4. 고찰 중소병원이 80% 이상을차지하는의료기관을대상으로외부정도관리를시행한결과일반화학검사항목별주요분석방법은 3년간특이적변화는보이지않았고, 측정종목에서한가지의원리가전체의 80% 를넘는항목이 BUN, Creatinine, Uric Acid, Protein, Albumin, T-Cholesterol, Triglyceride로나타났다. 종합병원이상에서참여하고있는신빙도조사사업의결과에서는참여기관의 90% 이상이 urease with glutamate dehydrogenase 법, Jaffe법, 비색법및효소법을사용하고있는것으로보고 [11] 하고있으며, 한가지의원리가전체의 80% 를넘는항목이 BUN, Uric Acid, Protein, Albumin, T-Cholesterol, ALT, AST, sodium, potassium, chloride, phosphorus로나타났다 [12]. 중소병원이많이참여하고있는본연구에서일반화학검사항목별분석방법이더다양한것으로나타났다. 외부정도관리는검사실에서시행한검사결과를다른검사실, 표준검사법 (reference ), 혹은표준검사실 (reference laboratory) 의검사결과와비교하여검사실의검사능력을평가하는것이다 [13]. 외부정도관리결과의평가방법은검사실의평균과표준편차를이용하는표준편차지수법 (standard deviation index, SDI) 또는영국의화학검사정도관리의평가를위해이용하는선택변이계수 (chosen coefficient of variation, CCV) 로계산하는변동지수점수법 (variation index score, VIS) 를사용한다 [14]. 선택변이계수 (CCV) 는영국국내화학검사정도관리의평가를위해 1971 년에선택된변이계수로서각검사종목에대해 United Kingdom National Quality Control Scheme 의몇해동안얻은가장낮은변이계수 (CV) 치를선택하여고정한값이다 [14]. 2종 ( 정상물질, 비정상물질 ) 의정도관리물질에대한검사항목별전체의료기관의변이계수는대부분의검사항목변이계수는선택변이계수보다낮은수치를나타내었으나, 다양한분석방법을사용하고있는 LDH, HDL-C, LDL-C 검사는높은변이계수를나타내었다. 또한, 분석방법에따라참고치의수치가큰차이를보이는 ALP, LDH 검사는높은변이계수를나타내었다. 종합병원이상의의료기관연구결과 [11,12] 에서는 10% 이상의변이계수를나타내는검사가 ALP, LDH, T-Bilirubin 으로중소의료기관이대다수를차지하는본연구에서변이계수가높은것으로나타났다. 이는중소의료기관의일반화학검사분석방법이다양하고, 같은원리의분석방법을사용하는참여기관수가적기때문으로사료된다. 외부정도관리에서는각항목에서평균 ±2표준편차이상의값을배제한후재계산한평균과표준편차값을기준으로사용하고있다 [12]. 각검사항목별평균 ±2표준편차를벗어나는값을이상치 (poor value) 로칭하고이상치의개수와관련요인을분석한결과, 외부정도관리를시행하고있지않은기관이시행하고있는의료기관보다, 내부정도관리시행주기가한달에몇번시행하는기관이매일실시하는의료기관보다이상치개수가유의하게높은것으로나타났다. 비건강검진기관보다건강검진기관이이상치의개수가높았으며, 병원의종별에따라의원이종합병원에비해이상치의개수가높은것으로나타났다. 또한, 의료기관의하루검체량이적을수록이상치의개수가유의하게많은것으로나타났다. 298

외부정도관리결과에서발생할수있는오류의원인은사무적오류, 검사과정의오류, 분석상의문제, 검체취급시의오류및정도관리물질자체검사의각과정에서일어날수있다 [15]. 본연구에서도이상치와같은오류발생은외부정도관리를실시하지않고, 내부정도관리의주기가매일이루어지지않으며, 검사량이적은일차의료기관에서많이발생하는것으로나타나일차의료기관의정도관리가검사결과의질에영향을미칠수있음을보여주고있다.

6 외부정도관리결과에서발생할수있는오류의원인은사무적오류, 검사과정의오류, 분석상의문제, 검체취급시의오류및정도관리물질자체검사의각과정에서일어날수있다 [15]. 본연구에서도이상치와같은오류발생은외부정도관리를실시하지않고, 내부정도관리의주기가매일이루어지지않으며, 검사량이적은일차의료기관에서많이발생하는것으로나타나일차의료기관의정도관리가검사결과의질에영향을미칠수있음을보여주고있다. 일차의료기관임상병리실의정도관리수준을평가한연구결과에서도정도관리개선의필요성을보고하고있으며계획적인교육의필요성을강조하고있다 [16]. 중소의료기관은일반화학의료장비의분석방법이다양한것으로나타났으며, 분석방법에따른원리가다양하므로변이계수가높은것으로나타났다. 또한중소의료기관은외부정도관리에참여하는기관수가적고내부정도관리주기가크기때문에검사결과의질향상을위하여지속적인관리와중소의료기관검사자만을위한맞춤교육이필요하다하겠다. References [1] J. Büttner, R. Borth, P. M.. Broughton, R. C. Bowyer, Approved recommendation (1983) on quality control in clinical chemistry IV Internal quality control, J Clin Chem Clin Biochem, Vol.21, No.12, pp , [2] M. M. Rizk, N. A. el-badawi, P. E. Moez, A. A. Khattab, "Implementation of quality control performance criteria and approved guidelines for upgrading of clinical chemistry laboratory procedures in Alexandria University hospitals", Clin Biochem, Vol.42, No.4-5, pp , DOI: [3] Y. K. Lee, "Annual Report on the External Quality Assessment Scheme for Routine Hematology in Korea (2016)", J Lab Med Qual Assur, Vol.39, No.2, pp , DOI: [4] M. Han, H. E. Chang, K. U. Park, J. Song, K. S. Han, Serum ferritin levels for normal hemoglobin blood donors in a Korean population, Korean J Blood Transfus, Vol.22, No.2, pp , [5] W. G. Miller, The role of proficiency testing in achieving standardization and harmonization between laboratories, Clin Biochem, Vol.42, pp , DOI: [6] Korean Association of External Quality Assessment Service. Reliability survey. KAEQAS. Available From: (accessed October, 24, 2018). [7] College of American Pathologists surveys catalog. CAP. Available From: Contribution%20Folders/WebContent/pdf/2019-surveys-c atalog.pdf (accessed October, 24, 2018). [8] Asian Network for Clinical Laboratory Standardization. Asian Quality Assurance Survey Program. ANCLS. Available From: (accessed October, 24, 2018). [9] United Kingdom National External Quality Assessment. International Quality Expertise. UK NEQAS. Available From: (accessed October, 24, 2018). [10] KS Han, MH Park, SI Kim. Transfusion medicine. 3rd ed. p , Seoul Korea Medical Book Publisher, [11] S. H. Jun, J. H. Song, W. H. Song, "Annual Report on the External Quality Assessment Scheme for Clinical Chemistry in Korea (2015)", J Lab Med Qual Assur, Vol.38, No.3, pp , DOI: [12] Y. W. Lee, B. R. Jeon, J. G. Kim, S. H. Jun, Y. M. Yun, S. I. Chun, J. H. Song, W. K. Min, Annual Report on the External Quality Assessment Scheme for Clinical Chemistry in Korea (2016), J Lab Med Qual Assur, Vol.39, No.2, pp , DOI: [13] Clinical and Laboratory Standards Institute. Using proficiency testing to improve the clinical laboratory; approved guideline-second edition. p. 1-45, CLSI. Document GP27-A2. Wayne, PA: CLSI., [14] Korea Society of Laboratory Medicine. Laboratory medicine. 5th ed. p.46-47, Seoul, Panmuneducation, [15] C. H. Ihm, H. S. Lim, Quality Management of Clinical Chemistry Tests in Blood Center, Korean J Blood Transfus, Vol.28, No.1, pp. 1-12, DOI: [16] S. S. Cho, M. S. Kim, K. A. Shin, Chemical Preservation Methods of Urine Sediment for Quality Control, Korean J Clin Lab Sci, Vol.49, No.4, pp , DOI: 김혜정 (Hye-Jeong Kim) [ 정회원 ] < 관심분야 > 혈액수혈학, 천연물효능평가, 독성학 1990 년 2 월 : 계명대학교공중보건학과 ( 학사 ) 2004 년 8 월 : 경북대학교보건학과 ( 석사 ) 2008 년 8 월 : 계명대학교공중보건학과 ( 박사 ) 2011 년 3 월 ~ 현재 : 경운대학교임상병리학과교수 299

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<31372DB1E8C0B1C8F12E687770> 임상검사와정도관리 : 제 28 권제 1 호 2006 J Lab Med Qual Assur 2006:28:213-217 213 외부정도관리물질을이용한내부정도관리시행의유용성 김윤희 보령아산병원진단검사의학과 The Usefulness of Internal Quality Control Procedure Using External Quality Control Materials