Public health implementation of pathogen genomics: the role for accreditation and application of ISO standards.

Pathogen genomics has transitioned rapidly from the research setting into a powerful tool now routinely used in public health microbiology, for surveillance, outbreak investigations and disease control. As these investigations can have significant public health, treatment and legal impacts, we must ensure the accuracy of these results through validation of testing processes. For laboratories working in this space, it is important to approach this work with a quality and accreditation framework in mind, working towards implementation of quality systems and test validation that meet international regulatory standards. Here we outline the key international standards and processes that lead toward accreditation for pathogen genomics.

A pilot study of on-site evaluation as external quality assessment for ISO 15189 accreditation of laboratories performing next-generation sequencing oncology tests.

BACKGROUND: As next-generation sequencing (NGS) oncology tests vary by platform, application, and target of genes, specific methods for external quality assessment (EQA) have not been universally applied. Hence, we have attempted to implement on-site evaluation as EQA in the accreditation program under ISO 15189 for laboratories that perform NGS oncology tests. METHODS: A total of 10 laboratories that performed NGS oncology tests were enrolled. Two types of EQA samples were prepared (Acrometrix Oncology Hotspot Control DNA and OncoSpan gDNA DNA samples), and the variant allele frequency of targeted genes was assigned. The samples were subjected to NGS oncology tests in participant laboratories according to their routine protocols. Based on the result reports, auditors visited the participant laboratories to perform on-site evaluations and provided feedback regarding possible laboratory process improvement. RESULTS: The participant laboratories identified the targeted variants in the Acrometrix Oncology Hotspot Control DNA and OncoSpan gDNA samples with a success rate of 31-100% and 9.5-100%, respectively, compared with reference information, depending on their sequencing systems, and reported a few lower-variant allele frequencies. Six of the eight evaluated laboratories failed to report at least three pathogenic variants due to errors in wet-lab and/or dry-lab processes. Based on the feedback reports and self-assessment, auditors and laboratory staff discussed potential improvements to processes during on-site evaluations for laboratory accreditations. CONCLUSIONS: On-site evaluation as EQA for NGS oncology tests in the laboratory accreditation program under ISO 15189 was successfully implemented and proved applicable to a broad spectrum of NGS tests.

Survey on the Construction Status of Forensic Virtual Autopsy Laboratory and the Applicability of Laboratory Accreditation.

OBJECTIVES: To survey the development status and actual needs of virtual autopsy technology in China and to clarify the applicability of forensic virtual autopsy laboratory accreditation. METHODS: The questionnaire was set up included three aspects：(1) the current status of virtual autopsy technology development; (2) the accreditation elements such as personnel, equipment, entrustment and acceptance, methods, environmental facilities; (3) the needs and suggestions of practicing institutions. A total of 130 forensic pathology institutions were surveyed by online participation through the Questionnaire Star platform. RESULTS: Among the 130 institutions, 43.08% were familiar with the characteristics of virtual autopsy technology, 35.38% conducted or received training in virtual autopsy, and 70.77% have establishment needs (including maintenance). Relevant elements were suitable for laboratory accreditation. CONCLUSIONS: Virtual autopsy identification has gained social recognition. There is a demand for accreditation of forensic virtual autopsy laboratory. After the preliminary assessment, considering the characteristics and current situation of this technology, China National Accreditation Service for Conformity Assessment (CNAS) can first carry out the accreditation pilot of virtual autopsy project at large comprehensive forensic institutions with higher identification capability, and then CNAS can popularize the accreditation in a wide range when the conditions are suitable.

Using the SLIPTA checklist to assess laboratory readiness for Joint Commission International accreditation.

Background: The Stepwise Laboratory Improvement Process Towards Accreditation (SLIPTA) helps prepare laboratories in low- and middle-income countries to achieve international accreditation aligned with the ISO 15189:2012 standards. Accreditation by the Joint Commission International (JCI) is among the highest sought by hospitals worldwide. While the readiness of laboratories with a five-star SLIPTA score to undergo ISO 15189:2012 accreditation was recently assessed, the compliance of the SLIPTA checklist with JCI is still unknown. Objective: The study evaluated the SLIPTA checklist's utility in assessing laboratories to meet the JCI standards. Methods: We conducted a detailed gap analysis between SLIPTA and JCI laboratory standards from January 2021 to January 2022. We cross-matched the JCI standard requirements to SLIPTA clauses and categorised each standard into 'met', 'partially met', and 'not met'. We highlighted similarities, discrepancies, and improvement areas. Results: A total of 109 JCI standards were included. The SLIPTA checklist completely met 61 standards, partially met four, but did not meet 44. The unmet JCI standards focused on the quality planning, control, and improvement sections. Healthcare organisation management and quality control processes, including selecting an accredited reference laboratory, collecting quality management data, creating of post-analytical policies and procedures, and validating monitoring systems, constitute the basis of this preparation. Conclusion: The SLIPTA checklist covers major quality management system elements of the JCI standards for laboratories. However, some components should be addressed to assure readiness for JCI accreditation. What this study adds: This study identified additional areas not covered by the SLIPTA checklist that are required for JCI accreditation.

Survey on the Construction Status of Forensic Virtual Autopsy Laboratory and the Applicability of Laboratory Accreditation / 法医学杂志

OBJECTIVES@#To survey the development status and actual needs of virtual autopsy technology in China and to clarify the applicability of forensic virtual autopsy laboratory accreditation.@*METHODS@#The questionnaire was set up included three aspects：(1) the current status of virtual autopsy technology development; (2) the accreditation elements such as personnel, equipment, entrustment and acceptance, methods, environmental facilities; (3) the needs and suggestions of practicing institutions. A total of 130 forensic pathology institutions were surveyed by online participation through the Questionnaire Star platform.@*RESULTS@#Among the 130 institutions, 43.08% were familiar with the characteristics of virtual autopsy technology, 35.38% conducted or received training in virtual autopsy, and 70.77% have establishment needs (including maintenance). Relevant elements were suitable for laboratory accreditation.@*CONCLUSIONS@#Virtual autopsy identification has gained social recognition. There is a demand for accreditation of forensic virtual autopsy laboratory. After the preliminary assessment, considering the characteristics and current situation of this technology, China National Accreditation Service for Conformity Assessment (CNAS) can first carry out the accreditation pilot of virtual autopsy project at large comprehensive forensic institutions with higher identification capability, and then CNAS can popularize the accreditation in a wide range when the conditions are suitable.

Repository of intra- and inter-run variations of quantitative autoantibody assays: a European multicenter study.

OBJECTIVES: No reference data are available on repositories to measure precision of autoantibody assays. The scope of this study was to document inter- and intra-run variations of quantitative autoantibody assays based on a real-world large international data set. METHODS: Members of the European Autoimmunity Standardisation Initiative (EASI) group collected the data of intra- and inter-run variability obtained with assays quantifying 15 different autoantibodies in voluntary participating laboratories from their country. We analyzed the impact on the assay performances of the type of immunoassay, the number of measurements used to calculate the coefficient of variation (CVs), the nature and the autoantibody level of the internal quality control (IQC). RESULTS: Data were obtained from 64 laboratories from 15 European countries between February and October 2021. We analyzed 686 and 1,331 values of intra- and inter-run CVs, respectively. Both CVs were significantly dependent on: the method of immunoassay, the level of IQC with higher imprecision observed when the antibody levels were lower than 2-fold the threshold for positivity, and the nature of the IQC with commercial IQCs having lower CVs than patients-derived IQCs. Our analyses also show that the type of autoantibody has low impact on the assay' performances and that 15 measurements are sufficient to establish reliable intra- and inter-run variations. CONCLUSIONS: This study provides for the first time an international repository yielding values of intra- and inter-run variation for quantitative autoantibody assays. These data could be useful for ISO 15189 accreditation requirements and will allow clinical diagnostic laboratories to assure quality of patient results.

Preparedness of district clinical laboratories towards ISO 15189: 2012 accreditation scheme in Lake Zone, Tanzania (a descriptive cross-sectional study).

Introduction: diagnosis, prevention, and surveillance of diseases relies on high quality laboratory services. However, accessibility and availability of the quality laboratory services among healthcare facilities remains a serious challenge among sub-Saharan African countries. This study investigated the preparedness of district clinical laboratories for ISO 15189: 2012 accreditation scheme using Stepwise Laboratory Quality Improvement Process towards Accreditation (SLIPTA) checklistin Lake Zone, Tanzania. Methods: this descriptive cross-sectional study was conducted from September 2018 to August 2019 among clinical laboratories at district hospitals and council designated hospitals in Lake Zone regions of Tanzania. Data were collected using the verified WHO-SLIPTA checklist. In each laboratory, either the laboratory manager, quality officer or safety officer was interviewed. Results: a total of 10 health laboratories affiliated to 6 districts and 4 councils designated hospitals were enrolled. Six laboratory managers and four quality officers were interviewed. Six (60%) and 4 (40%) laboratories were under government ownership and private ownership, respectively. The majority (70%, n=7) of medical district laboratories in Lake Zone-Tanzania were not registered for WHO-SLIPTA. Conclusion: about two third of district and council designated hospital laboratories in Lake zone are not registered for WHO-SLIPTA indicating unpreparedness towards ISO 15189: 2012 accreditation.

Strengthening Medical Laboratory Systems in Kenya: An Innovative Biosafety Training Model.

Background: With increased rates of laboratory-acquired infections from clinical and research laboratories globally, efforts have been made to improve awareness of modern practices and pursue innovations in biosafety to manage risks and laboratory exposures arising from infectious agents and other hazards. Objectives: This article demonstrates a sustainable biosafety training model developed to enhance laboratory quality and support accreditation in health facilities in Kenya. Methods: A biosafety technical working group was formed, and sensitization meetings held with health managers. Trainings were then conducted for training of trainers (TOTs) who then cascaded trainings in health facilities. This was followed by mentorships and monitoring for implementation. Results: Five sensitization meetings were carried out for 264 health managers. TOTs was done for 48 trained trainers and 1044 laboratory workers in 216 facilities covering 44 counties. Site visits were done in 51 facilities, with biosafety achievements measured in 21 (41%), respectively. Achievements in 21 facilities included the following: improvised eye wash stations in 16 facilities (76%), biological spill kits in 17 (81%), buckets of sand in 15 (71%), fire extinguishers in 12 (57%), hepatitis B vaccination in 14 (66%), establishment of phlebotomy areas in 18 facilities (85%), material safety data sheets in 18 (85%), documentation of incidents and exposures in 16 (76%), and proper waste segregation in 17 (81%). Conclusion: This model ensured rapid scale-up to multiple counties and enabled learners to understand biosafety principles. Due to management buy-in, resources were availed to implement interventions, and this was demonstrated by remarkable achievements across all assessed facilities.

Managing Deviating EQA Results: A Survey to Assess the Corrective and Preventive Actions of Medical Laboratories Testing for Oncological Biomarkers.

Laboratories testing predictive biomarkers in lung and colorectal cancer are advised to participate in external quality assessment (EQA) schemes. This study aimed to investigate which corrective actions were taken by laboratories if predetermined performance criteria were not met, to ultimately improve current test practices. EQA participants from the European Society of Pathology between 2014 and 2018 for lung and colorectal cancer were contacted, if they had at least one analysis error or test failure in the provided cases, to complete a survey. For 72.4% of 514 deviating EQA results, an appropriate action was performed, most often including staff training (15.2%) and protocol revisions (14.6%). Main assigned persons were the molecular biologist (40.0%) and pathologist (46.5%). A change in test method or the use of complex techniques, such as next-generation sequencing, required more training and the involvement of dedicated personnel to reduce future test failures. The majority of participants adhered to ISO 15189 and implemented suitable actions by designated staff, not limited to accredited laboratories. However, for 27.6% of cases (by 20 laboratories) no corrective action was taken, especially for pre-analytic problems and complex techniques. The surveys were feasible to request information on results follow-up and further recommendations were provided.

Precision of autoantibody assays in clinical diagnostic laboratories: What is the reality?

BACKGROUND: ISO 15189 accreditation remains a challenge for specialized laboratories. In the field of autoimmunity, beside the crucial problem of absence of standardization, laboratories have to manage the analytical performances of the large panel of assays in terms of sensitivity and specificity, but also on their measurement precision for which no reference values are available on biorepositories. METHODS: As an initiative of the French EASI (European Autoimmunity Standardization Initiative) group, French clinical diagnostic laboratories were requested to participate in a survey aiming to analyze the coefficients of variation (CVs) of intra-run and inter-run variability obtained with assays quantifying 14 different autoantibodies. Two performance goals corresponding to the 90th percentile and the 50th percentile (lowest CV values reached by 90% and 50% of laboratories respectively) defined for three levels of concentration were calculated. The impact on the assay performances of the number of measurements, of the nature of the internal quality control (IQC) and the type of immunoassay, was also analyzed. RESULTS: 414 and 616 values of intra-run and inter-run CVs were collected, respectively. The 50th percentile performance goals were comprised between 1.0% and 8.9% for the intra-run CVs, and between 1.8% and 14.6% for the inter-run CVs. At 90th percentile, the performance goals were comprised between 3.2% and 13.5% for the intra-run CVs, and between 7.3% and 30.8% for the inter-run CVs. CVs calculated from 10 values were similar to those obtained from more values. Higher imprecision was observed when the antibody levels of the IQC was lower than 2 fold the positive threshold. Commercial IQCs gave lower CVs than IQCs derived from patient samples. CONCLUSION: Our results allow proposing some acceptability limits for the precision performances of the autoantibody assays, compatible with the reality of life in diagnostic laboratories and clinical care.

Glucose point-of-care meter operators competency: An assessment checklist.

BACKGROUND AND OBJECTIVES: Glucose point-of-care testing meters are essential technology ubiquitous in hospitals. They are operated by non-specialized staff who are assessed through an auto-recertification process that is dependent on operators successfully producing expected outcomes. Alternatively, we suggest that operator practices be directly observed using a competency assessment checklist. METHOD: We designed a checklist based on literature and manufacturers' instructions and tested it by observing 30 operators at two sites (three hospitals) over two months in 2018. RESULTS: Despite all operators being auto-recertified, the checklist revealed that only 20% met the 80% threshold of compliance to standards. Moreover, the site with a POCT coordinator had a compliance rate of 82% versus 67% for the site that did not. DISCUSSION: The checklist is more reliable than auto-recertification in assessing operators' competence. It also highlights areas for process improvement and provides an opportunity to give personalized feedback to operators.

Medical laboratory accreditation in a resource-limited district health centre laboratory, Addis Ababa, Ethiopia.

BACKGROUND: Improving the quality of medical laboratory services is a high priority in many countries. However, quality management systems for laboratories in resource-limited settings are often inadequate. OBJECTIVES: This article shares the experiences, benefits and challenges of the laboratory journey towards accreditation in a primary healthcare laboratory in Addis Ababa, Ethiopia. METHODS: A retrospective review of laboratory records in Addis Ketema Health Center was conducted from 2012 to 2015. The study was supplemented by observations from some of the authors of this article who worked in the laboratory. RESULTS: The laboratory journey towards accreditation began with a baseline assessment in 2012 using the World Health Organization African Region Stepwise Laboratory Quality Improvement Process Towards Accreditation; the baseline score was 78 points (0 stars). After mentorship support, the laboratory improved to 198 points (3 stars) in 2013 and 249 points (5 stars) in 2014. The laboratory scaled up to International Organization for Standardization 15189 requirements and received limited-scope accreditation for tuberculosis sputum microscopy and hematology tests in 2015. After adopting and implementing the standards, steady improvement was observed in the reliability of the laboratory services. Lack of resources was the major challenge the laboratory encountered. CONCLUSION: Even though a remarkable quality performance improvement was observed over the entire process, inadequate skilled personnel was the major challenge identified in the road towards accreditation. Therefore, an appropriate, workload-based staffing structure should be developed to improve and sustain medical laboratory quality standards in resource-limited settings.

Acreditación de los laboratorios de Andrología en la República Argentina / Accreditation of Andrology laboratories in Argentina / Credenciamento dos laboratórios de Andrologia na República Argentina

La acreditación de laboratorios especializados en Andrología tiene como objetivo promover, mejorar y asegurar la calidad del servicio. Las especialidades requieren de la participación de expertos que asesoren a los organismos autónomos que efectúan las auditorías de tercera parte. El objetivo del trabajo es comunicar la experiencia de trabajo cooperativo llevado a cabo por una sociedad científica, la Sociedad Argentina de Andrología (SAA) y el Programa de Acreditación de Laboratorios (PAL) de la Fundación Bioquímica Argentina (FBA) para el aseguramiento de la calidad de la prestación bioquímica en el área andrológica. Con tal fin se firmó un convenio marco y específico de colaboración para la acreditación de laboratorios especializados en Andrología. La FBA llevaría a cabo la logística del proceso, con su plantel de auditores, aplicando como instrumento el Manual de Acreditación MA3 y la SAA proveería asesoramiento científico. Junto con las autoridades del PAL se elaboró un documento que especifica los apartados correspondientes al MA3 capítulo Nº 4 Anexo Nº 4, "Estándares para la acreditación de laboratorios especializados". Se realizó capacitación para la elaboración de la documentación y formación de los auditores en la especialidad. Esta experiencia demuestra que el trabajo cooperativo entre organizaciones permite alcanzar logros a favor de la seguridad del paciente.

Laboratory accreditation aims to promote, improve and ensure the quality of the service. The specialties require the participation of experts who advise the autonomous bodies that carry out third-party audits. The objective is to communicate the experience of cooperative work carried out by a scientific society, the Sociedad Argentina de Andrología (SAA) (Argentine Society of Andrology) and the Laboratory Certification Programme (PAL for its name in Spanish) of Fundación Bioquímica Argentina (FBA) (Argentine Biochemistry Foundation) for quality assurance of the biochemical work in the andrology area. To reach this goal, a framework and specific collaboration agreement was signed for the certification of specialized laboratories in Andrology. The FBA will carry out the logistics of the process, with its auditors' staff, applying the MA3 Accreditation Manual as an instrument, and the SAA will provide scientific advice. Together with the PAL authorities, a document was drawn to specify the sections corresponding to the MA3 chapter No. 4 Annex No. 4, "Standards for the certification of specialized laboratories". Training was carried out to prepare the documentation and the auditors in the specialty were trained as well. This experience has proven that cooperative work between organizations can achieve results favouring the patient's safety.

O credenciamento dos laboratórios visa promover, melhorar e garantir a qualidade do serviço. As especialidades requerem a participação de profissionais que assessoram os órgãos autônomos que realizam auditorias de terceiros. O objetivo é comunicar a experiência do trabalho cooperativo realizado por uma sociedade científica, a Sociedade Argentina de Andrologia (SAA) e o Programa de Credenciamento (PAL) da Fundação Bioquímica Argentina (FBA) para garantir a qualidade do trabalho bioquímico na área andrológica. Para esse fim, foi assinado um acordo-quadro e específico de cooperação para o credenciamento de laboratórios especializados em Andrologia. A FBA iria executar a logística do processo, com a sua equipe de auditores, por meio do Manual de Credenciamento MA3 como instrumento e a SAA como um instrumento e a SAA forneceria assessoramento científico. Junto com as autoridades do PAL foi elaborado um documento especificando as seções relativas ao MA3 capítulo Nº 4 Anexo Nº 4, "Normas para a credenciamento de laboratórios especializados". O treinamento foi realizado para a elaboração da documentação e formação dos auditores na especialidade. Essa experiência tem demonstrado que o trabalho cooperativo entre organizações permite atingir resultados positivos para a segurança do paciente.

The association of imaging equipment age with other quality metrics and successful laboratory accreditation by the Intersocietal Accreditation Commission.

BACKGROUND: Intersocietal Accreditation Commission (IAC) accreditation is granted or delayed depending on the fulfillment of several quality metrics. Investing in up-to-date equipment might reflect a commitment to quality. METHODS: Data from echocardiography (n = 3079) and nuclear cardiology (n = 1835) accreditation applications submitted between 2012 and 2014 were evaluated to determine the mean age of laboratory equipment. Laboratory quality was assessed by the number of missing quality metrics, and a composite quality score was calculated as the sum of missing quality metrics. A lower score thus represented better laboratory quality. The relationship between equipment age and quality was explored as an interaction term between equipment age and the composite quality score and was incorporated into regression models for prediction of accreditation status. RESULTS: During the study period, 49% of echocardiography and 42% of nuclear laboratories were granted accreditation without delay. For both echocardiography and nuclear laboratories, there was a statistically significant trend toward an increasing number of missing quality metrics with increasing quartiles of equipment age. The interaction between equipment age and the composite quality score was a significant predictor of delay of accreditation for both echocardiography and nuclear cardiology laboratories, with a stronger association for 1st-time applicants. Among sites applying for accreditation in both modalities simultaneously, accreditation in one modality predicted the accreditation decision for the other. CONCLUSIONS: Laboratory quality is an important determinant of IAC accreditation, and equipment age is an effect modifier of this relationship. Contemporary equipment likely reflects a commitment to quality, for both echocardiography and nuclear laboratories.

Development of Statistical Software for the Korean Laboratory Accreditation Program Using R Language: LaboStats.

BACKGROUND: In Korea, the Korean Laboratory Accreditation Program (KLAP) has set minimum standards for verification of clinical test performance. This verification process is time-consuming and labor-intensive when performed manually. We developed a free, statistical software program for KLAP, using the R language (R Foundation for Statistical Computing, Vienna, Austria). METHODS: We used CLSI guidelines for the algorithm. We built graphic user interfaces, including data input, with Embarcadero Delphi EX4 (Embarcadero Technologies, Inc., Texas, USA). The R Base Package and MCR Package for Method Comparison Regression were used to implement statistical and graphical procedures. RESULTS: Our program LaboStats has six modules: parallel test, linearity, method comparison, precision, reference interval, and cutoff. Data can be entered into the field either manually or by copying and pasting from an MS Excel worksheet. Users can print out precise reports. CONCLUSIONS: LaboStats can be useful for evaluating clinical test performance characteristics and preparing documents requested by KLAP.

Development of Statistical Software for the Korean Laboratory Accreditation Program Using R Language: LaboStats

BACKGROUND: In Korea, the Korean Laboratory Accreditation Program (KLAP) has set minimum standards for verification of clinical test performance. This verification process is time-consuming and labor-intensive when performed manually. We developed a free, statistical software program for KLAP, using the R language (R Foundation for Statistical Computing, Vienna, Austria). METHODS: We used CLSI guidelines for the algorithm. We built graphic user interfaces, including data input, with Embarcadero Delphi EX4 (Embarcadero Technologies, Inc., Texas, USA). The R Base Package and MCR Package for Method Comparison Regression were used to implement statistical and graphical procedures. RESULTS: Our program LaboStats has six modules: parallel test, linearity, method comparison, precision, reference interval, and cutoff. Data can be entered into the field either manually or by copying and pasting from an MS Excel worksheet. Users can print out precise reports. CONCLUSIONS: LaboStats can be useful for evaluating clinical test performance characteristics and preparing documents requested by KLAP.

Accreditation and Quality Assurance for Clinical Liquid Chromatography-Mass Spectrometry Laboratories.

For mass spectrometry (MS) testing in the clinical laboratory, postimplementation monitoring for quality is just as important as method development and validation but often receives less attention. Quality-assurance monitoring for liquid chromatography-tandem MS (LC-MS/MS) testing should be proactive rather than reactive and should monitor the entire testing process. An LC-MS/MS quality-assurance plan should cover overall batch review parameters, individual peak review parameters, system and reagent changes, and assessment of long-term accuracy. This article discusses Clinical Laboratory Improvement Amendments' regulations as they apply to LC-MS/MS-based testing and reviews available guidelines for LC-MS/MS quality assurance and postimplementation monitoring.

Budget Impact of the Accreditation Program for Clinical Laboratories on Colorectal Cancer Screening via Fecal Immunochemical Testing: Results from the National Cancer Screening Program in Korea.

BACKGROUND: False-positive fecal immunochemical test (FIT) results in the National Cancer Screening Program (NCSP) for colorectal cancer may lead to unnecessary procedures, such as colonoscopies, increasing the medical costs. We estimated reductions in the cost of National Health Insurance according to the accreditation status of screening facilities participating in the NCSP for colorectal cancer. METHODS: We used data collected between 2007 and 2010 from NCSP and the Korea Central Cancer Registry to identify patients with colorectal cancer. We also ascertained the history of the accreditation of each facility by the Korean Laboratory Accreditation Program (KLAP). Budget impact was defined as a reduction in medical costs achieved when the false-positive rate of the non-accredited facilities decreased relative to that of the accredited facilities. RESULTS: A total of 3,285 screening facilities participated in the NCSP. Of these, 196 were accredited by the KLAP. The false-positive rate of the accredited facilities was 2.47%, and that of the non-accredited facilities was 6.83%. Medical costs were estimated to be reduced by approximately 19 million US dollars (USD), and the cost of detecting one case of colorectal cancer was estimated to decrease from 9,212 USD to 7,332 USD if the false-positive rate of non-accredited facilities were decreased to that of the accredited facilities. Clinics were estimated to have the largest associated cost reduction. CONCLUSIONS: Quality assurance in clinical laboratories could lower false-positive rates and prevent the use of unnecessary procedures, ensuring patient safety and increasing the cost-effectiveness of FIT screening in the NCSP for colorectal cancer.

Budget Impact of the Accreditation Program for Clinical Laboratories on Colorectal Cancer Screening via Fecal Immunochemical Testing: Results from the National Cancer Screening Program in Korea

BACKGROUND: False-positive fecal immunochemical test (FIT) results in the National Cancer Screening Program (NCSP) for colorectal cancer may lead to unnecessary procedures, such as colonoscopies, increasing the medical costs. We estimated reductions in the cost of National Health Insurance according to the accreditation status of screening facilities participating in the NCSP for colorectal cancer. METHODS: We used data collected between 2007 and 2010 from NCSP and the Korea Central Cancer Registry to identify patients with colorectal cancer. We also ascertained the history of the accreditation of each facility by the Korean Laboratory Accreditation Program (KLAP). Budget impact was defined as a reduction in medical costs achieved when the false-positive rate of the non-accredited facilities decreased relative to that of the accredited facilities. RESULTS: A total of 3,285 screening facilities participated in the NCSP. Of these, 196 were accredited by the KLAP. The false-positive rate of the accredited facilities was 2.47%, and that of the non-accredited facilities was 6.83%. Medical costs were estimated to be reduced by approximately 19 million US dollars (USD), and the cost of detecting one case of colorectal cancer was estimated to decrease from 9,212 USD to 7,332 USD if the false-positive rate of non-accredited facilities were decreased to that of the accredited facilities. Clinics were estimated to have the largest associated cost reduction. CONCLUSIONS: Quality assurance in clinical laboratories could lower false-positive rates and prevent the use of unnecessary procedures, ensuring patient safety and increasing the cost-effectiveness of FIT screening in the NCSP for colorectal cancer.

International Organization for Standardization (ISO) 15189.

The College of American Pathologists (CAP) offers a suite of laboratory accreditation programs, including one specific to accreditation to the international organization for standardization (ISO) 15189 standard for quality management specific to medical laboratories. CAP leaders offer an overview of ISO 15189 including its components, internal audits, occurrence management, document control, and risk management. The authors provide a comparison of its own ISO 15189 program, CAP 15189, to the CAP Laboratory Accreditation Program. The authors conclude with why laboratories should use ISO 15189.