Status of Pre-analytical Quality Management of Laboratory Tests at Primary Clinics in Korea

Background@#The quality of laboratory test results is crucial for accurate clinical diagnosis and treatment. Pre-analytical errors account for approximately 60%–70% of all laboratory test errors. Laboratory test results may be largely impacted by pre-analytical phase management. However, primary care clinics currently do not have pre-analytical quality management audit systems. We aimed to understand the current status of pre-analytical quality management in laboratory medicine in Korean primary care clinics. @*Methods@#Questionnaires were designed to focus on essential components of the pre-analytical process of primary care clinics. An online survey platform was used to administer the survey to internal medicine or family medicine physicians in primary care clinics. @*Results@#A total of 141 physicians provided a complete response to the questionnaire. In 65.2% of the clinics, patient information was hand-labeled rather than barcoded on the specimen bottles; 14.2% of clinics displayed only one piece of patient information (name or identification number), and 19.9% of clinics displayed two pieces of information. Centrifuges were not available in 29.1% of the clinics. Institutions carrying out the National Health Screening Program (NHSP) used more barcode system and had more centrifuges than institutions that did not carrying out the NHSP. @*Conclusions@#Pre-analytical quality management is inadequate in many primary clinics. We suggest implementation of a mandatory management system, allowing for a pre-analytical quality management to be carried out in primary care clinics.

A New Strategy for Evaluating the Quality of Laboratory Results for Big Data Research: Using External Quality Assessment Survey Data (2010–2020)

Background@#To ensure valid results of big data research in the medical field, the input laboratory results need to be of high quality. We aimed to establish a strategy for evaluating the quality of laboratory results suitable for big data research. @*Methods@#We used Korean Association of External Quality Assessment Service (KEQAS) data to retrospectively review multicenter data. Seven measurands were analyzed using commutable materials: HbA1c, creatinine (Cr), total cholesterol (TC), triglyceride (TG), alpha-fetoprotein (AFP), prostate-specific antigen (PSA), and cardiac troponin I (cTnI). These were classified into three groups based on their standardization or harmonization status. HbA1c, Cr, TC, TG, and AFP were analyzed with respect to peer group values. PSA and cTnI were analyzed in separate peer groups according to the calibrator type and manufacturer, respectively. The acceptance rate and absolute percentage bias at the medical decision level were calculated based on biological variation criteria. @*Results@#The acceptance rate (22.5%–100%) varied greatly among the test items, and the mean percentage biases were 0.6%–5.6%, 1.0%–9.6%, and 1.6%–11.3% for all items that satisfied optimum, desirable, and minimum criteria, respectively. @*Conclusions@#The acceptance rate of participants and their external quality assessment (EQA) results exhibited statistically significant differences according to the quality grade for each criterion. Even when they passed the EQA standards, the test results did not guarantee the quality requirements for big data. We suggest that the KEQAS classification can serve as a guide for building big data.

Comparison of Thyroid-Stimulating Hormone Results from Eight Different Reagents and Assay-Specific Korean Reference Interval for Subclinical Hypothyroidism Treatment

Background and Objectives@#Recent guidelines from the Korean Thyroid Association have proposed a threshold of 6.8 mIU/L for diagnosing subclinical hypothyroidism based on local research findings. However, due to the lack of standardization/harmonization, thyroid-stimulating hormone (TSH) testing yields varying results across different reagent manufacturers. Hence, the use of uniform reference intervals is challenging. We aimed to establish assay-specific Korean reference interval for TSH. @*Materials and Methods@#We performed duplicate measurements on 100 serum samples with varying TSH concentrations (0-23 mIU/L) using eight different TSH reagents including Alinity I TSH (Abbott), Access TSH (Beckman Coulter), Elecsys TSH (Roche), TSH3UL (Siemens),TSH IRMA (Beckman Coulter), TSH1 RIA (Brahms), TSH IRMA TUBE II (Riakey), Turbo TSH IRMA (Izotop).Correlation and simple linear regression analyses were conducted among 8 reagents with Roche as the reference. @*Results@#The correlation coefficient for each reagent was notably high at 0.99. Through regression analysis, TSH values equivalent to the 6.8 mIU/L (Roche) were determined for each reagent as follows: Abbott 5.2 mIU/L, Beckman 6.5 mIU/L, Siemens 6.9 mIU/L, Beckman-Radioimmunoassay 7.4 mIU/L, Brahms 5.7 mIU/L, Riakey 5.3 mIU/L, Izotop 6.0 mIU/L. Conclusion: Given the observed differences in TSH values associated with different reagents, it is imperative to consider these differences when interpreting results within various clinical contexts and adapting them to clinical practice.

Standardization Status of Total Cholesterol Concentration Measurement: Analysis of Korean External Quality Assessment Data

Background@#Total cholesterol concentration measurement is important in the diagnosis of dyslipidemia and evaluation of cardiovascular disease risk factors. Measurement reliability for obtaining an accurate total cholesterol concentration requires procedure standardization. We evaluated the standardization status for total cholesterol concentration measurement through Korean external quality assessment (EQA) data analysis. @*Methods@#This study involved 1,670 laboratories that participated in the EQA of total cholesterol concentration measurements in 2019 for 32 products from different manufacturers. The target concentrations of three quality control (QC) materials (samples A, B, and C) were measured using the reference method and compared with EQA data. The performance criteria for total cholesterol concentration measurement were based on the National Cholesterol Education Program guidelines, with ± 3% inaccuracy. @*Results@#The target values and inaccuracies of the QC material based on the reference method measurements were 254.65 ± 7.64, 108.30 ± 3.25, and 256.29 ± 7.69 mg/dL (6.59 ± 0.20, 2.80 ± 0.08, and 6.63 ± 0.20 mmol/L) for samples A, B, and C, respectively.The performance criteria were not met in 42.7% laboratories for sample A, 68.4% of laboratories for sample B, and 38.0% laboratories for sample C. @*Conclusions@#Despite significant efforts to accurately measure total cholesterol concentrations, further actions are needed for measurement standardization. Manufacturers reporting values that differ from target values should check calibrator traceability; additional efforts to accurately measure total cholesterol concentrations are required for laboratories that use products from these manufacturers.

Schemes and Performance Evaluation Criteria of Korean Association of External Quality Assessment (KEQAS) for Improving Laboratory Testing

External quality assessment (EQA) is important for evaluating clinical laboratories and enhancing their testing quality. EQA schemes are variable; thus, it is crucial that the EQA organizers share their experiences to continuously improve the EQA scheme. The Korean Association of External Quality Assessment Service (KEQAS) has been the leading, authorized EQA institute for the standardization and quality management of laboratory testing in Korean medical institutions since 1976. The EQA scheme underwent a major change in 2016, and the number of EQA programs increased significantly since then. The key changes implemented in EQA scheme include a fully computerized assessment to accelerate feedback and unification of the testing and reporting methods. We provide an overview of the EQA schemes and performance evaluation criteria of the KEQAS and suggest directions for achieving the global harmonization of EQA.

Effects of the new diagnosis-related group-based payment system and the increased incentive policy rates on the utilization rate of diagnostic laboratory test in Korea

A new diagnosis-related group (DRG) based payment system has been implemented in most public hospitals in Korea. We investigated the effects of the new DRG system and its incentive policy on the utilization rate of diagnostic laboratory tests. Three groups were categorized; 36 hospitals under the new DRG system (participant group), 72 hospitals (control-1) matching with 36 participants according to the number of beds, and 42 tertiary hospitals (control-2). The patients of acute myocardial infarction, cerebral infarction, type 2 diabetes mellitus, and gonarthrosis receiving total arthroplasty were included. We analyzed the mean length of stay and the number of diagnostic laboratory tests conducted during hospitalization of the three groups according to the new DRG system and the incentive policy rates under the new DRG system. Before participating in the new DRG system, the number of diagnostic laboratory tests in the participant group was less than that in the two control groups for all four diseases. However, although the participant group’s length of stay decreased under the new DRG system, the number of diagnostic laboratory tests increased as the maximum incentive policy rate increased. The increment of the number of diagnostic laboratory tests was prominent in the period of a maximum of 35% incentive policy rates. Finally, the number of diagnostic laboratory tests of the participant group was similar to or exceeded that of the control-2 group. The new DRG system’s incentive policy rates played a driving force on the increased utilization rate of the diagnostic laboratory test. For preparing in advance for the change in incentive policy rates, monitoring and guidelines for the utilization of diagnostic laboratory tests are necessary.

Turnaround Time (TAT) Setting Status of 30 Domestic Clinical Laboratories and Consideration for Improvement and Management of TAT

Background@#Turnaround time (TAT) is a major quality control indicator and can be defined differently depending on the starting point in the examination process. To determine effective TAT management plan, we investigated the status of TAT management in clinical laboratories in Korea. @*Methods@#A questionnaire was developed using Google web pages and a questionnaire survey was conducted at 30 clinical laboratories in laboratory medicine from September 1 to 11 in 2018. Questions were developed regarding management time, starting point standards, management goals, most problematic stages of delayed TAT, clinical measures, and shortening barriers for investigation. @*Results@#All clinical laboratories requested to undertake the survey completed the questionnaire (response rate 100%, 30/30) and answered that they were setting and managing TAT for all tests. Many laboratories (33%) set the TAT starting point as the reception stage, prior to commencing centrifugation. Of the surveyed laboratories, 37% achieved a TAT of 120 min or more for general tests, 27% met the TAT of 90 min for pre-clinic tests, and 77% met the TAT of 60 min for completion of stat tests. Most laboratories (67%) reported that the most delayed stage was pre-analysis, and 50% reported that the greatest obstacle to shortening TAT was the ratio of stat and pre-clinic tests to general tests. @*Conclusions@#The laboratories participating in this survey set a TAT based on various criteria and were performing management for TAT improvement. The results of this study can be used as basic data to guide efficient TAT management.

Korean Clinical Laboratory Accreditation Program Quality Standards for Laboratory Management: Identifying a Compliance Gap with World Health Organization Quality System Essentials

Background@#The Laboratory Medicine Foundation (LMF) checklists explain the accreditation requirements of the program and reflect quality standards like those of the Clinical Laboratory Standards Institute (CLSI) or quality system essentials (QSE) of the World Health Organization (WHO). In this study, we have analyzed how the LMF checklists correlate with the 12 QSE elements of the WHO. @*Methods@#The LMF checklists for laboratory management (LM) (version 2019) were classified into the 12 specific QSE elements by five laboratory physicians. Each checklist item was classified into specific element if four or more participants agreed, and into overlapping elements when two or more of them agreed for two different items. Any changes in checklist items and chapter structuring of the checklist since 2009 were investigated. @*Results@#The LM checklists consisted of 183 checklist items, including 20 (10.9%) classified into overlapping QSE elements. The QSE element with the highest number of items was the facilities and safety (62, 33.9%), followed by the personnel (22, 12.0%), and the process control (17, 9.3%). In contrast, QSE elements with the lowest number of items were the customer service (4, 2.2%) and process improvement (4, 2.2%). Items belonging to the customer service and the organization elements have increased since 2017. @*Conclusions@#The LMF checklists reflect current quality goals for clinical laboratories and play a leading role in the laboratory's quality improvement. The results of our study will be of help in potentiating the quality leader role of LMF checklists, and international harmonization of our laboratory accreditation program.

Turnaround Time (TAT) Setting Status of 30 Domestic Clinical Laboratories and Consideration for Improvement and Management of TAT

Background@#Turnaround time (TAT) is a major quality control indicator and can be defined differently depending on the starting point in the examination process. To determine effective TAT management plan, we investigated the status of TAT management in clinical laboratories in Korea. @*Methods@#A questionnaire was developed using Google web pages and a questionnaire survey was conducted at 30 clinical laboratories in laboratory medicine from September 1 to 11 in 2018. Questions were developed regarding management time, starting point standards, management goals, most problematic stages of delayed TAT, clinical measures, and shortening barriers for investigation. @*Results@#All clinical laboratories requested to undertake the survey completed the questionnaire (response rate 100%, 30/30) and answered that they were setting and managing TAT for all tests. Many laboratories (33%) set the TAT starting point as the reception stage, prior to commencing centrifugation. Of the surveyed laboratories, 37% achieved a TAT of 120 min or more for general tests, 27% met the TAT of 90 min for pre-clinic tests, and 77% met the TAT of 60 min for completion of stat tests. Most laboratories (67%) reported that the most delayed stage was pre-analysis, and 50% reported that the greatest obstacle to shortening TAT was the ratio of stat and pre-clinic tests to general tests. @*Conclusions@#The laboratories participating in this survey set a TAT based on various criteria and were performing management for TAT improvement. The results of this study can be used as basic data to guide efficient TAT management.

Effect of Having a Usual Source of Care on Medical Expenses – Using the Korea Health Panel Data

BACKGROUND: There is a controversy about the effect of having a usual source of care on medical expenses. Although many studies have shown lower medical expenses in a group with a usual source of care, some have shown higher medical expenses in such a group. This study aimed to empirically demonstrate the effect of having a usual source of care on medical expenses. METHODS: The participants included those aged 20 years and older who responded to the questionnaire about “having a usual source of care” from the Korean Health Panel Data of 2012, 2013, and 2016 (6,120; 6,593; and 7,598 respectively). Those who responded with “I do not get sick easily” or “I rarely visit medical institutions” as the reasons for not having a usual source of care were excluded. The panel regression with random effects model was performed to analyze the effect of having a usual source of care on medical expenses. RESULTS: The group having a usual source of care spent 20% less on inpatient expenses and 25% less on clinic expenses than the group without a usual source of care. Particularly, the group having a clinic-level usual source of care spent 12% less on total medical expenses, 9% less on outpatient expenses, 35% less on inpatient expenses, and 74% less on hospital expenses, but 29% more on clinic expenses than the group without a usual source of care. CONCLUSION: This study confirmed that medical expenses decreased in the group with a usual source of care, especially a clinic-level usual source of care (USC), than in the group without a usual source of care. Encouraging people to have a clinic-level USC can control excessive medical expenses and induce desirable medical care utilization.

Report on the Project for Establishment of the Standardized Korean Laboratory Terminology Database, 2015

The National Health Information Standards Committee was established in 2004 in Korea. The practical subcommittee for laboratory test terminology was placed in charge of standardizing laboratory medicine terminology in Korean. We aimed to establish a standardized Korean laboratory terminology database, Korea-Logical Observation Identifier Names and Codes (K-LOINC) based on former products sponsored by this committee. The primary product was revised based on the opinions of specialists. Next, we mapped the electronic data interchange (EDI) codes that were revised in 2014, to the corresponding K-LOINC. We established a database of synonyms, including the laboratory codes of three reference laboratories and four tertiary hospitals in Korea. Furthermore, we supplemented the clinical microbiology section of K-LOINC using an alternative mapping strategy. We investigated other systems that utilize laboratory codes in order to investigate the compatibility of K-LOINC with statistical standards for a number of tests. A total of 48,990 laboratory codes were adopted (21,539 new and 16,330 revised). All of the LOINC synonyms were translated into Korean, and 39,347 Korean synonyms were added. Moreover, 21,773 synonyms were added from reference laboratories and tertiary hospitals. Alternative strategies were established for mapping within the microbiology domain. When we applied these to a smaller hospital, the mapping rate was successfully increased. Finally, we confirmed K-LOINC compatibility with other statistical standards, including a newly proposed EDI code system. This project successfully established an up-to-date standardized Korean laboratory terminology database, as well as an updated EDI mapping to facilitate the introduction of standard terminology into institutions.

Clinical Pharmacogenetic Testing and Application: Laboratory Medicine Clinical Practice Guidelines

Pharmacogenetic testing for clinical applications is steadily increasing. Correct and adequate use of pharmacogenetic tests is important to reduce unnecessary medical costs and adverse patient outcomes. This document contains recommended pharmacogenetic testing guidelines for clinical application, interpretation, and result reporting through a literature review and evidence-based expert opinions for the clinical pharmacogenetic testing covered by public medical insurance in Korea. This document aims to improve the utility of pharmacogenetic testing in routine clinical settings.

Predictive Value of Dental Maturity for a Positive Gonadotropin-Releasing Hormone Stimulation Test Result in Girls with Precocious Puberty

Dental maturity is associated with skeletal maturity, which is advanced in girls with central precocious puberty (CPP). We investigated the performance of dental maturity as a screening method for CPP using mandibular second premolar and molar calcification stages, assessed the associated anthropometric and laboratory factors, and evaluated pubertal response predictors using the gonadotropin-releasing hormone stimulation test (GnRHST) in prepubertal and pubertal girls. A prospective case-control study was conducted in girls, aged 7.0–8.9 years, classified into pubertal (peak luteinizing hormone [LH] after GnRHST ≥ 5 IU/L), prepubertal (peak LH < 5 IU/L), and control groups. Auxological and biochemical tests, panoramic radiographs, and GnRHSTs in participants with breast development were conducted. Dental maturity was assessed using the Demirjian index (DI). We included 103 girls (pubertal, 40; prepubertal, 19; control, 44). Chronological age (CA) was not significantly different between groups. Bone age (BA) and BA advancement was higher in the pubertal and prepubertal groups. Increased DI values at the mandibular second premolar and molar were significantly associated with CA, BA, BA advancement, height standard deviation score (SDS), peak LH after GnRHST, and insulin-like growth factor-I (IGF-I) (all P < 0.05). Moreover, odds ratio (OR) of the mandibular second premolar and molar (a DI value of ≥ E) for predicting a positive response to GnRHST was 8.7 (95% confidence intervals [CI], 2.9–26.1) and 5.2 (95% CI, 2.2–12.7), respectively. Dental maturity was a strong predictor for diagnosing CPP. Determining dental maturity in girls with suspected precocious puberty might help determine the performance of GnRHSTs.

Renoprotective effects of febuxostat compared with allopurinol in patients with hyperuricemia: A systematic review and meta-analysis

BACKGROUND: Hyperuricemia is reported to be related to rapid progression of renal function in patients with chronic kidney disease (CKD). Allopurinol, a uric acid lowering agent, protects renal progression. However, it is not widely used in patients with CKD because of its serious adverse event. Febuxostat can be alternatively used for patients who are intolerable to allopurinol. We aimed to determine renoprotective effect and urate-lowering effect between the two drugs. METHODS: We performed a systematic review and meta-analysis of randomized controlled trials to assess the effects of febuxostat compared to allopurinol in patients with hyperuricemia. MEDLINE, Embase, and Cochrane Library databases were searched to identify research publications. RESULTS: Four relevant publications were selected from among 3,815 studies. No significant differences were found in the changes in serum creatinine from baseline between the febuxostat and allopurinol groups. Changes in estimated glomerular filtration rate (eGFR) were observed between the two groups at 1 month (mean difference 1.65 mL/min/1.73 m², 95% confidence interval [CI] 0.38, 2.91 mL/min/1.73 m²; heterogeneity χ² = 1.25, I² = 0%, P = 0.01); however, the changes in eGFR were not significantly different at 3 months. A significant difference did exist in the changes in albuminuria levels from baseline between the febuxostat and allopurinol groups (mean difference −80.47 mg/gCr, 95% CI −149.29, −11.64 mg/gCr; heterogeneity χ² = 0.81, I² = 0%, P = 0.02). A significant difference was also observed in the changes in serum uric acid from baseline between the febuxostat and allopurinol groups (mean difference −0.92 mg/dL, 95% CI −1.29, −0.56 mg/dL; heterogeneity χ² = 6.24, I² = 52%, P < 0.001). CONCLUSION: Febuxostat might be more renoprotective than allopurinol.

A Survey on the Awareness and Usage of the National Transfusion Guideline in Korea / 대한수혈학회지

BACKGROUND: Transfusion guidelines play an important role for the appropriate use and quality assurance of blood and transfusion services. The Korean national transfusion guideline was developed in 2009 and went under full amendment in 2016. The purpose of this study was to investigate the awareness and practicality of the transfusion guideline in Korea. METHODS: Questionnaires about the Korean national transfusion guideline were sent by traditional mail or e-mail to a total of 1,179 clinicians, 32 academic societies, and 6 institutions. RESULTS: Three hundred and seventy-four answers were received; a response rate of 30.7%. The proportion of respondents with good awareness of the guideline was 23.3%, which is a significant increase compared with 10.9% in 2008. Respondents with good awareness were more dependent on the transfusion guideline when making transfusion decisions. CONCLUSION: There was a considerable increase in the awareness of the national transfusion guideline in Korea.

Clinical Pharmacogenetic Testing and Application: Laboratory Medicine Clinical Practice Guidelines Part 1

Pharmacogenetics is a rapidly evolving field, and the number of pharmacogenetic tests for clinical use is steadily increasing. However, incorrect or inadequate implementation and use of pharmacogenetic testing in clinical practice may result in an increase in medical costs and adverse patient outcomes. This document contains suggested pharmacogenetic testing guidelines for clinical application, interpretation, and reporting of the results through a literature review and evidence-based expert opinions. The clinical laboratory practice guideline includes clinical pharmacogenetic testing covered by public medical insurance in Korea. Technical, ethical, and regulatory issues related to clinical pharmacogenetic testing are also addressed. This document aims to improve the utility of pharmacogenetic testing in routine clinical settings.

Bacteremia Caused by Eggerthella lenta in an Elderly Patient with an Intra-abdominal Abscess

Eggerthella lenta is an anaerobic, non-spore-forming, non-motile, gram-positive bacillus that can be isolated from human feces and a few other clinical specimens. Bacteremia caused by the organism is rare but, when present, is always of clinical significance. E. lenta is an emerging pathogen that has been under-recognized because of difficulties with its laboratory identification. Few reports on E. lenta infections and the optimal treatment thereof are available. We describe a case of bacteremia caused by E. lenta in an elderly patient with an intra-abdominal abscess. We also review the current literature.

Comparison of the Ability of Multiplex and Singleplex PCR to Detect Human Respiratory Viruses

BACKGROUND: The use of the multiplex polymerase chain reaction (PCR) technique for respiratory viruses has become popular in Korea owing to its convenience and sensitivity. However, concerns remain with regard to possible interference due to multiplexing. METHODS: We compared the analytical sensitivity and virus interference of a commercially available, multiplex PCR kit (AdvanSure Respiratory virus real-time PCR kit, LG Life Sciences, Korea) with that of singleplex PCR to detect 11 viruses including coronavirus 229E and OC43; parainfluenza virus 1 (PIV 1), parainfluenza virus 2 (PIV 2), and parainfluenza virus 3 (PIV 3); influenza virus A (INF A) and influenza virus B (INF B); respiratory syncytial virus A (RSV A) and respiratory syncytial virus B (RSV B); adenovirus; and rhinovirus A, B, and C. RESULTS: The lowest detected viral concentrations of coronavirus 229E and OC43, INF A and B, RSV A and B, adenovirus, and rhinovirus A, B, and C were the same for both, multiplex and singleplex systems. However, the lowest detected viral concentrations of PIV1, 2, and 3 differed by 1 dilution factor between the two systems. Threshold cycle (Ct) values for mixed viruses within the same well were not significantly influenced by each other, where the difference between Ct values ranged from 0.24 to 1.99. CONCLUSIONS: Analytical sensitivity of multiplex PCR was comparable to that of singleplex PCR for respiratory viruses. No significant interference was observed with mixed virus samples using multiplexed PCR.

Clinical Pharmacogenetic Testing and Application: Laboratory Medicine Clinical Practice Guidelines Part 2

Pharmacogenetics is a rapidly evolving field and the number of pharmacogenetic tests for clinical use is steadily increasing. However, incorrect or inadequate implementation of pharmacogenetic tests in clinical practice may result in a rise in medical costs and adverse outcomes in patients. This document suggests guidelines for the clinical application, interpretation, and reporting of pharmacogenetic test results based on a literature review and the collection of evidence-based expert opinions. The clinical laboratory practice guidelines encompass the clinical pharmacogenetic tests covered by public medical insurance in Korea. Technical, ethical, and regulatory issues related to clinical pharmacogenetic tests have also been addressed. In particular, this document comprises the following pharmacogenetic tests: CYP2C9 and VKORC1 for warfarin, CYP2C19 for clopidogrel, CYP2D6 for tricyclic antidepressants, codeine, tamoxifen, and atomoxetine, NAT2 for isoniazid, UGT1A1 for irinotecan, TPMT for thiopurines, EGFR for tyrosine kinase inhibitors, ERBB2 (HER2) for erb-b2 receptor tyrosine kinase 2-targeted therapy, and KRAS for anti-epidermal growth factor receptor drugs. These guidelines would help improve the usefulness of pharmacogenetic tests in routine clinical settings.

False-Positive Elevation of Creatine Kinase MB Mass Concentrations Caused by Macromolecules in a Patient who Underwent Nephrectomy for Renal Cell Carcinoma

No abstract available.