Purpose: Immunochemical fecal occult blood tests (iFOBT) have been utilized as the primary method for colorectal cancer screening within Korea's National Cancer Screening Program. This study aimed to evaluate the impact of the accreditation program for clinical laboratories and external quality assessment (EQA) programs on colorectal cancer screening. Methods: We analyzed the false-positive rates of iFOBT in colorectal cancer screening from 2016 to 2020 according to participation and performance in the Outstanding Laboratory Accreditation Program (OLAP) conducted by the Laboratory Medicine Foundation, and the External Quality Assessment programs run by the Korean Association of External Quality Assessment Service. Results: False-positive rates of iFOBT were lower among institutions accredited by OLAP (2.35%) compared with non-accredited (3.04%) and non-participating institutions (5.60%). Similarly, institutions participating in the EQA program exhibited lower false-positive rates (3.79%) compared to non-participants (7.04%). Within the iFOBT-specific EQA program, institutions that passed demonstrated the lowest false-positive rate (3.37%), while failing institutions showed the highest rate (9.07%), surpassing even non-participating institutions (6.44%). Conclusion Participation in quality management programs such as OLAP and EQA was associated with lower false-positive rates in iFOBT for colorectal cancer screening. These findings suggest that quality management initiatives can increase the accuracy of iFOBT, potentially improving the effectiveness of colorectal cancer screening programs, and reducing unnecessary follow-up procedures and associated healthcare costs.

Purpose: Immunochemical fecal occult blood tests (iFOBT) have been utilized as the primary method for colorectal cancer screening within Korea's National Cancer Screening Program. This study aimed to evaluate the impact of the accreditation program for clinical laboratories and external quality assessment (EQA) programs on colorectal cancer screening. Methods: We analyzed the false-positive rates of iFOBT in colorectal cancer screening from 2016 to 2020 according to participation and performance in the Outstanding Laboratory Accreditation Program (OLAP) conducted by the Laboratory Medicine Foundation, and the External Quality Assessment programs run by the Korean Association of External Quality Assessment Service. Results: False-positive rates of iFOBT were lower among institutions accredited by OLAP (2.35%) compared with non-accredited (3.04%) and non-participating institutions (5.60%). Similarly, institutions participating in the EQA program exhibited lower false-positive rates (3.79%) compared to non-participants (7.04%). Within the iFOBT-specific EQA program, institutions that passed demonstrated the lowest false-positive rate (3.37%), while failing institutions showed the highest rate (9.07%), surpassing even non-participating institutions (6.44%). Conclusion Participation in quality management programs such as OLAP and EQA was associated with lower false-positive rates in iFOBT for colorectal cancer screening. These findings suggest that quality management initiatives can increase the accuracy of iFOBT, potentially improving the effectiveness of colorectal cancer screening programs, and reducing unnecessary follow-up procedures and associated healthcare costs.

Purpose: Immunochemical fecal occult blood tests (iFOBT) have been utilized as the primary method for colorectal cancer screening within Korea's National Cancer Screening Program. This study aimed to evaluate the impact of the accreditation program for clinical laboratories and external quality assessment (EQA) programs on colorectal cancer screening. Methods: We analyzed the false-positive rates of iFOBT in colorectal cancer screening from 2016 to 2020 according to participation and performance in the Outstanding Laboratory Accreditation Program (OLAP) conducted by the Laboratory Medicine Foundation, and the External Quality Assessment programs run by the Korean Association of External Quality Assessment Service. Results: False-positive rates of iFOBT were lower among institutions accredited by OLAP (2.35%) compared with non-accredited (3.04%) and non-participating institutions (5.60%). Similarly, institutions participating in the EQA program exhibited lower false-positive rates (3.79%) compared to non-participants (7.04%). Within the iFOBT-specific EQA program, institutions that passed demonstrated the lowest false-positive rate (3.37%), while failing institutions showed the highest rate (9.07%), surpassing even non-participating institutions (6.44%). Conclusion Participation in quality management programs such as OLAP and EQA was associated with lower false-positive rates in iFOBT for colorectal cancer screening. These findings suggest that quality management initiatives can increase the accuracy of iFOBT, potentially improving the effectiveness of colorectal cancer screening programs, and reducing unnecessary follow-up procedures and associated healthcare costs.

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.

BACKGROUND: Although the same equipment and reagents can be employed for inspecting identical samples, the setting and verification methods for the corresponding reference intervals differ from each other, and such methods are not well established. To address the issues associated with establishing and validating reference intervals, a Web-based application is proposed for collaboratively setting reference intervals. METHODS: A Web application was designed for automatically providing the statistical results associated with a reference interval upon receiving the corresponding test results from participating institutions and incorporating the cumulative data. RESULTS: By employing the proposed Web-based application (www.referencerange.org), reference intervals can be collaboratively set based on objective and statistical analyses incorporating clinical chemistry results obtained from Korea Healthcare Association in the years 2016 and 2017. Cumulative data obtained from the existing input peer group associated with an inspection are updated in real time, and the current set reference interval is displayed in real time. CONCLUSIONS: In this study, a Web-based application is designed for collaboratively setting reference intervals whereby all Korean laboratories can easily participate, collectively set reference intervals, and apply the set reference intervals. Hence, the proposed application can aid in providing basic data associated with health information.
Chemistry, Clinical ; Delivery of Health Care ; Indicators and Reagents ; Korea ; Peer Group