OBJECTIVES: To develop a quality control indicator system for neonatal screening of inherited metabolic diseases in obstetric settings, so as to provide a standardized tool for quality control in clinical neonatal screening of inherited metabolic diseases. METHODS: From March to May 2024, a literature review combined with expert clinical experience was conducted to develop a preliminary questionnaire on quality control indicators for neonatal screening of inherited metabolic diseases. The final indicator system was established after two rounds of the Delphi method, and the Analytic Hierarchy Process was used to determine indicator weights. RESULTS: Sixteen questionnaires were distributed in each of the two consultation rounds, with a valid response rate of 100% for both. The expert authority coefficients were 0.863 and 0.876, respectively. Kendall's coefficient of concordance for the importance and feasibility of the indicators ranged from 0.091 to 0.125. The final indicator system comprised 3 primary indicators, 8 secondary indicators, and 28 tertiary indicators for neonatal screening of inherited metabolic diseases in obstetric settings. CONCLUSIONS The quality control indicator system developed using the Delphi method demonstrates a strong systematic structure, high clinical adaptability, and strong operability, and can be effectively applied to quality control in neonatal screening of inherited metabolic diseases in obstetric settings.
Humans ; Infant, Newborn ; Neonatal Screening/standards* ; Quality Control ; Metabolism, Inborn Errors/diagnosis* ; Metabolic Diseases/diagnosis* ; Delphi Technique ; Female ; Quality Indicators, Health Care ; Pregnancy

On March 19, 2021, the National Medical Products Administration(NMPA) issued the Regulations on the Supervision and Administration of Medical Devices (Order No. 739 of the State Council of the People's Republic of China), which clearly stipulated in Article 53 the basic definition and scope of use of in vitro diagnostic reagents developed by medical institutions. It also pointed out that the relevant administrative measures shall be formulated by the Drug Regulatory Department of the State Council in conjunction with the Health Department of the State Council. This initiative marks the re-incorporation of in vitro diagnostic reagents developed by medical institutions into China's regulatory system. This study reviewed the development of regulatory policies for self-developed in vitro diagnostic reagents at home and abroad, combined with the Key Points of On-site Verification of Self-developed In Vitro Diagnostic Reagents in Shanghai Medical Institutions issued by the Shanghai Municipal Drug Administration, in conjunction with the Shanghai Municipal Health Commission, and the specific verification work of pre-record evaluation, and sorted out the general requirements for the quality management system of self-developed in vitro diagnostic reagents. The purpose is to provide some references for the further development of this pilot work and its nationwide promotion.
China ; Quality Control ; Indicators and Reagents/standards* ; Reagent Kits, Diagnostic/standards*

This study aimed to explore key quality control factors that affected the prognosis of intensive care unit (ICU) patients in Chinese mainland over six years (2015-2020). The data for this study were from 31 provincial and municipal hospitals (3425 hospital ICUs) and included 2 110 685 ICU patients, for a total of 27 607 376 ICU hospitalization days. We found that 15 initially established quality control indicators were good predictors of patient prognosis, including percentage of ICU patients out of all inpatients (%), percentage of ICU bed occupancy of total inpatient bed occupancy (%), percentage of all ICU inpatients with an APACHE II score ⩾15 (%), three-hour (surviving sepsis campaign) SSC bundle compliance (%), six-hour SSC bundle compliance (%), rate of microbe detection before antibiotics (%), percentage of drug deep venous thrombosis (DVT) prophylaxis (%), percentage of unplanned endotracheal extubations (%), percentage of patients reintubated within 48 hours (%), unplanned transfers to the ICU (%), 48-h ICU readmission rate (%), ventilator associated pneumonia (VAP) (per 1000 ventilator days), catheter related blood stream infection (CRBSI) (per 1000 catheter days), catheter-associated urinary tract infections (CAUTI) (per 1000 catheter days), in-hospital mortality (%). When exploratory factor analysis was applied, the 15 indicators were divided into 6 core elements that varied in weight regarding quality evaluation: nosocomial infection management (21.35%), compliance with the Surviving Sepsis Campaign guidelines (17.97%), ICU resources (17.46%), airway management (15.53%), prevention of deep-vein thrombosis (14.07%), and severity of patient condition (13.61%). Based on the different weights of the core elements associated with the 15 indicators, we developed an integrated quality scoring system defined as F score=21.35%xnosocomial infection management + 17.97%xcompliance with SSC guidelines + 17.46%×ICU resources + 15.53%×airway management + 14.07%×DVT prevention + 13.61%×severity of patient condition. This evidence-based quality scoring system will help in assessing the key elements of quality management and establish a foundation for further optimization of the quality control indicator system.
Humans ; China/epidemiology* ; Cross Infection/epidemiology* ; Intensive Care Units/statistics & numerical data* ; Quality Control ; Quality Indicators, Health Care/statistics & numerical data* ; Sepsis/therapy* ; East Asian People/statistics & numerical data*

Objective: To evaluate the newborn hearing screening program in the University of Santo Tomas Hospital based on the quality indicators set by the Joint Committee on Infant Hearing (JCIH) 2019 position statement. Methods: Design: Cross-sectional study Setting: Tertiary Private Training Hospital Participants: All newborns delivered in 2019 at the University of Santo Tomas (UST) Hospital were considered for inclusion Results: The UST Hospital had 778 newborns in 2019, of which 687 (88.3%) completed newborn hearing screening by 1 month of age. There were 81 (10.4%) who failed initial hospitalbased screening and required outpatient re-screening while 11 (1.4%) of those who failed initial screening also failed subsequent rescreening. Forty-five (5.7%) newborns failed initial screening and subsequently passed re-screening. None of the eleven (0/11) patients completed comprehensive audiologic evaluation thus, patients necessitating referral for intervention were not identified. There were a total of 67 (8.6%) dropouts throughout the hearing evaluation process. Fifteen (15) infants were not screened due to unavailability of trained personnel at time of referral, four (4) infants were advised third screening while two (2) were advised observation instead of proceeding to confirmatory test. Conclusion The University of Santo Tomas Hospital newborn hearing screening program has yet to reach the quality indicators set by the Joint Committee on Infant Hearing 2019 for screening and confirmation of hearing loss. Among identified areas for improvement are the availability of trained personnel, insufficient means to ensure compliance, reluctance to pursue further testing and practices among healthcare providers.
otoacoustic emission ; diagnostics ; quality indicators

In recent years, transanal total mesorectal excision (taTME) has been a hot spot in the field of colorectal surgery. Compared with the traditional laparoscopic technique, taTME has potential advantages in the treatment of rectal diseases. However, the procedural safety and effectiveness of taTME need further verification. In order to ensure the safe and standardized implementation of this procedure, the European Society of Coloproctology, together with 14 international academic organizations related to colorectal surgery and minimally invasive surgery, has developed the international expert consensus guidance on indications, implementation and quality measures for taTME. This paper introduces the background of the international consensus guidance, and interprets its core contents, including the surgical indications (complex pelvic conditions, malignant and benign rectal diseases), surgical quality and outcome evaluation, structured training, and expert center. It is expected to provide reference and guidance for Chinese colorectal surgery colleagues performing taTME.
Consensus ; Humans ; Laparoscopy ; Quality Indicators, Health Care ; Rectal Neoplasms/surgery* ; Rectum/surgery* ; Transanal Endoscopic Surgery

BACKGROUND: For creatinine measurement, the enzymatic method is known to be more accurate than the Jaffe method; however, the latter is still widely used. We evaluated the performance of the CRE2 reagent (Siemens Healthcare Diagnostics Inc., USA), which uses a modified Jaffe method. METHODS: Three quality control standards were used for precision evaluations of CRE2 on Dimension VISTA 500 instrument (Siemens). Moreover, the linearity and carryover characteristics were assessed. Sixty-eight creatinine results obtained using the CRE2 and ECREA (enzymatic) reagents (Siemens) were compared with those obtained using the L-CRE (enzymatic) reagent (Shinyang Diagnostics, Korea). The accuracy of CRE2, ECREA, and L-CRE was evaluated using a standard reference material. RESULTS: The CV of within-run (0.7–2.4%), between-run (0.4–1.7%), between-day precision (0.7–0.9%) for three standards, and total CV for medium (1.6%) and high levels (1.3%) satisfied the analytical goal. The linearity for CRE2 was excellent (R2=0.999). Comparisons of CRE2 and ECREA to L-CRE were well correlated (r=0.996 and 0.997, respectively). In comparison with L-CRE, 5 CRE2 results and 15 ECREA results exceeded minimum bias goal (5.1%) in samples with creatinine levels of >1 mg/dL. The carryover rate was −0.04%. In terms of accuracy, the percent bias values of CRE2, ECREA, and L-CRE were 7.4, −6.4, and −3.4, respectively, for low level; and 3.9, −1.5, and 0.7, respectively, for high level. CONCLUSIONS: For creatinine measurements, the CRE2 reagent showed good performance. It can be used in the diagnosis, treatment monitoring, and risk assessment of kidney diseases.
Bias (Epidemiology) ; Creatinine* ; Delivery of Health Care ; Diagnosis ; Indicators and Reagents ; Kidney Diseases ; Methods ; Quality Control ; Risk Assessment

BACKGROUND: Rheumatoid factor (RF) is used as one of the diagnostic criteria for rheumatoid arthritis. The purpose of this study was to evaluate qualitative RF reagents used in clinical laboratories in Korea, and to provide basic data that can be used as a reference to improve the quality of RF testing. METHODS: We reviewed the proficiency testing results for RF from the Korean Association of External Quality Assessment Service (KEQAS) and College of American Pathologists. Moreover, we evaluated five commercially available RF qualitative reagents, including LabSlide RF (IVD Lab Co., Korea), ASAN RA Latex Reagents (Asan Pharmaceuticals Co., Korea), RaPET RF (Stanbio Laboratory, USA), RF Latex Test (Pulse Scientific Inc., Canada), and RF-100 (Teco Diagnostics, USA). Commercially available quality control materials, calibrators, and pooled sera were used in this study. The consistency of qualitative reagents and Kappa statistics were calculated based on the quantitative values of the quality control materials and the mixed sera. RESULTS: Up to 51.5% of high concentration samples were reported as negative in KEQAS. RF qualitative reagent test results were not consistent among reagent types. The consistency of the qualitative and quantitative test results was between 51% and 100%, and the kappa statistics varied depending on the reagent manufacturer. CONCLUSIONS: Measurement of RF qualitative reagents used in domestic clinical laboratories was not consistent with the quantitative values, and hence it is necessary to improve the consistency and verify the adequacy of the cut-off value.
Arthritis, Rheumatoid ; Chungcheongnam-do ; Indicators and Reagents ; Korea ; Latex ; Quality Control ; Rheumatoid Factor

In 2018, external quality assessment trials for urinalysis and fecal occult blood (FOB) were performed using 1,590 participants. Urine chemistry tests were performed thrice while urine sediment and FOB tests twice. Urine chemistry tests comprised of pH, protein, glucose, ketone body, bilirubin, blood, urobilinogen, nitrite, leukocyte, and specific gravity analyses. The results of urine chemistry and specific gravity tests showed accuracy rates >95%, except for the pH test. The accuracy rate of urine sediments was low, especially for atypical calcium oxalate crystal and red blood cell cast. In the FOB quality test, reagents showed accuracy rates >90%, except for SD and GC Genedia FOB reagents. In the FOB quantitative test, Alfresa NS-Plus C instrument showed falsely high values in the FOB negative specimens.
Bilirubin ; Calcium Oxalate ; Chemistry ; Erythrocytes ; Glucose ; Hydrogen-Ion Concentration ; Indicators and Reagents ; Leukocytes ; Occult Blood ; Quality Control ; Specific Gravity ; Urinalysis ; Urobilinogen

BACKGROUND: Quality control is important for accurate diagnosis of human immunodeficiency virus (HIV) infection, and proficiency testing with external quality controls is an important part of quality control. This study intended to develop and supply customized external quality controls for HIV antigen/antibody testing fitted with currently used reagents for standardization of HIV infection diagnosis and evaluation of HIV testing competency of laboratories in Korea. METHODS: Serological tests and inactivation were performed on the obtained HIV antibody positive plasma. To manufacture quality controls having the required antibody titers, dilution ratio was searched using VIDAS (bioMérieux, France), Architect (Abbott Laboratories, USA), and Cobas 8000 (Roche Diagnostics, Germany) analyzers. Diluted source plasma was divided into aliquots after filtering. Homogeneity and stability of the produced external quality controls were evaluated. RESULTS: The collected HIV antibody positive plasma was confirmed by Western blot. Dilution ratios for source plasma were produced for each analyzer showing signal-to-cut-off 2–3, 5–7, and 15–16 reactivity. Diluted plasma was made to 1 mL aliquots and total set of 1,500 external quality controls for HIV antigen/antibody were manufactured. Produced controls satisfied the required criteria of homogeneity and showed less than 10% coefficient of variation for stability except negative controls. CONCLUSIONS: Customized external quality controls were developed and qualified for HIV testing reagents used in Korea. Continuous external quality control assessment for HIV tests with controls would be required.
Blotting, Western ; Diagnosis ; HIV Infections ; HIV* ; Humans* ; Indicators and Reagents ; Korea* ; Plasma ; Quality Control* ; Serologic Tests

BACKGROUND: The purpose of this study is to investigate relationship between the horse racing addiction and the health status indicators. METHODS: Surveys were conducted with visitors of the Korea Racing Association in Gyeonggi-do, from September 1 to September 24, 2017. We used the questionnaire, which contains questions to assess the horse racing addiction, mood depression, health-related quality of life, smoking amount, alcohol dependency, etc. Survey data were analyzed through t-test, chi-square test, logistic regression analysis, and multiple regression analysis by SPSS program (IBM Corp., Chicago, IL, USA). RESULTS: The pathological gambling group was 47.5% (n=38) of the visitors, and they showed a different racecourse use behavior compared to the normal group. In addition, we found that the pathological gambling group had a significantly different health-related quality of life score and a depression score from the normal group, and that the addiction score and the depression score had a linear correlation. CONCLUSIONS: Among the racecourse visitors, the ratio of the pathological gambler was considerably high, and the pathological gambling group showed different health-related quality of life score and a depression score compared to the normal group; especially, the depression score has a significant correlation with horse racing addiction. Therefore, the horse racing association and the health authorities should recognize the seriousness of the horse racing addiction, make an effort to select high risk users, and prepare a program to prevent pathological gambling.
Continental Population Groups ; Depression ; Gambling ; Gyeonggi-do ; Health Status Indicators ; Horses ; Humans ; Korea ; Logistic Models ; Quality of Life ; Smoke ; Smoking