Old signage faced iconography, variable layouts, visual presentations, and contents, as well as degradation issues, undermine the effectiveness of hazard communication in the laboratory. A 2016 project was initiated to standardize all hazard signages at the Laboratory Research Division of the Research Institute for Tropical Medicine (RITM), incorporating standard colors and iconography for better compliance and safety. As part of a broader initiative to enhance biorisk practices within the institute, there are plans for improvement and expansion to non-laboratory areas.

Background: According to the guidelines of the Department of Health (DOH)’s Health Facilities and Services Regulatory Bureau (HFSRB), accreditation of drug testing laboratories (DTLs) requires annual participation in a proficiency testing (PT) program. Since 2009, the National Reference Laboratory for Environmental and Occupational Health, Toxicology and Micronutrient Assay of the East Avenue Medical Center (NRL-EAMC) has conducted the PT program for DTLs. Objectives: This article aims to provide a general overview of the PT program conducted for screening drug testing laboratories (SDTLs) and to examine data on laboratories’ participation and performance in the PT program. Methodology: Laboratories registered for the PT program were given ten 3-mL synthetic urine specimens which may or may not contain drugs of abuse such as methamphetamine and tetrahydrocannabinol at or above the cut-off level. Laboratories analyzed the PT specimens using immunoassay test kits. The results of the analysis were reported back to NRL-EAMC. The performance of the laboratories in the PT depends on the number of incorrect responses. Results: For ten years (2009-2019), 1102 ± 188 laboratories annually participated in the program. The mean passing rate was 96.6 ± 4.8%. The number of laboratories which initially failed the PT program significantly decreased from 2009 (15.1%) to 2012 (1.5%). From 2013 to 2019, only below 2.5% of the participating laboratories initially failed the PT. On average, 48.4 ± 18.4% of the laboratories achieved an excellent performance, 34.0 ± 13.6% had a highly satisfactory performance, and 14.3 ± 5.4% got an acceptable performance. Conclusion The continued decreasing number of laboratories which failed the PT signifies the improvement of laboratories in urine drug testing. In general, some laboratories participating in the PT for the first time are the ones which initially fail the PT which could be due to a lack of experience in handling PT test items. The PT program highlights the effectiveness of quality control procedures being implemented in a drug testing laboratory.
Laboratories ; Quality Control ; Accreditation ; Methamphetamine

OBJECTIVE: Taking artificial hip joint test as the object, integrating ISO/IEC 17025 and GLP, and establishing a new set of management requirements for test influence factors. METHODS: The requirements of ISO/IEC 17025 and GLP regulations for influencing factors were compared and analyzed, the similarities and differences were found, and the two were integrated to formulate new management requirements for each influencing factor. RESULTS: From the personnel, equipment, materials, methods, reports, filing and other factors, a set of management requirements in line with ISO/IEC 17025 and GLP was formulated, so that the laboratory can provide the objective, real and accurate test data for medical equipment manufacturers and regulatory authorities. CONCLUSIONS It can improve the test quality of the laboratory and ensure the authenticity and reliability of the test data and conclusions.
Reproducibility of Results ; Laboratories ; Hip Joint

Objective: To characterize the serum bile acid profiles of healthy children in Zhejiang Province. Methods: A cross-sectional study was conducted on 245 healthy children who underwent imaging and laboratory biochemical tests during routine physical examinations at the Children's Hospital of Zhejiang University School of Medicine from January 2020 to July 2022. Overnight fasting venous blood samples were collected, and the concentrations of 18 individual bile acids in the serum were accurately quantitated using tandem mass spectrometry. The concentration difference of bile acid were compared between different genders and to explore the correlation between age and bile acid levels. Used the Mann-Whitney U test for intergroup comparison and Spearman test to correlation analysis. Results: A total of 245 health children with a age of 10 (8, 12) years including 125 boys and 120 girls. There were no significant differences in levels of total bile acids, primary and secondary bile acids, free and conjugated bile acids between the two gender groups (all P>0.05). The serum concentrations of ursodeoxycholic acid and glycoursodeoxycholic acid in girls were significantly higher than those in boys (199.0 (66.9, 276.5) vs. 154.7 (49.3, 205.0) nmol/L, 274.0 (64.8, 308.0) vs. 181.0 (43.8, 209.3) nmol/L, Z=2.06, 2.71, both P<0.05). The serum taurolithocholic acid in both boys and girls were positively correlated with age (r=0.31, 0.32, both P<0.05). The serum chenodeoxycholic acid and glycochenodeoxycholic acid in the boys group were positively correlated with age (r=0.20, 0.23, both P<0.05), whereas the serum tauroursodeoxycholic acid in the girls group was negatively correlated with age (r=-0.27, P<0.05), and the serum cholic acid was positively correlated with age (r=0.34, P<0.05). Conclusions: The total bile acid levels are relatively stable in healthy children in Zhejiang province. However, individual bile acids showed gender differences and were correlated with age.
Humans ; Child ; Female ; Male ; Cross-Sectional Studies ; Bile Acids and Salts ; Hospitals, Pediatric ; Laboratories

OBJECTIVE: To compare the prevalence of chromosomal aneuploidies and pregnancy outcomes of D5 and D6 blastocysts subjected to preimplantation genetic testing for aneuploidy (PGT-A). METHODS: Clinical and laboratory data of 268 couples who underwent PGT-A at the Reproductive Center of the First Affiliated Hospital of Zhengzhou University from September 2018 to September 2020 were collected. The prevalence of chromosomal aneuploidies and pregnancy outcomes of D5/D6 biopsied blastocysts were compared. RESULTS: Compared with D6 blastocysts, the euploidy rate of D5 blastocysts was significantly higher (49.1% vs. 41.1%, P = 0.001 1), whilst their aneuploidy rate was significantly lower (50.9% vs. 58.9%, P = 0.001 1). The rate of numerical abnormalities of D6 blastocysts was significantly higher than that of D5 blastocysts (27.9% vs. 20.2%, P = 0.000 5). For patients under 35 years old, the euploidy rate of D5 blastocysts was significantly higher than that of D6 blastocysts (53.8% vs. 44.3%, P = 0.001), whilst the numerical abnormality rate was significantly lower (16.3% vs. 23.9%, P = 0.001). For both D5 and D6 blastocysts, the euploidy rates for patients <= 35 were significantly higher than those for > 35. The elder group had the lowest rates for aneuploidies and live births. Compared with those receiving D6 blastocysts transplantation, the pregnancy rate, implantation rate and live birth rate for those receiving thawed D5 blastocysts transplantation were significantly higher (60.2% vs.37.0%, P = 0.000 3; 59.1% vs.37.0%, P = 0.000 6; 47.7% vs. 28.3%, P = 0.002). CONCLUSION For patients undergoing PGT-A, the chromosomal euploidy rate for D5 blastocysts is higher than that for D6 blastocysts, and the clinical outcome of D5 blastocysts with normal signal is better than that of D6 blastocysts. Elder patients have a higher rate of aneuploidies.
Female ; Pregnancy ; Humans ; Aged ; Adult ; Pregnancy Outcome ; Aneuploidy ; Blastocyst ; Genetic Testing ; Laboratories

INTRODUCTION

Inferior vena cava (IVC) filters entrap emboli from the periphery going to the pulmonary circulation, preventing pulmonary embolism (PE). Studies show that many IVC filter insertions are done for weak or non–guideline directed indications. This study examined the indications for IVC filter insertion in a tertiary care hospital in Metro Manila, adherence to society guidelines, and clinical outcomes after filter insertion.

This study is a retrospective cohort involving patients who received an IVC filter from January 2015 to February 2021. The main outcome was the indication for IVC filter. Other outcomes were strength of recommendation for filter placement and postfilter clinical outcomes: all-cause death, venous thromboembolism–related mortality, PE, and filter related complications.

Eighty-three patients received IVC filters from January 2015 to February 2021, and 77 were included in the analysis. Sixty-one percent had moderate to strong indications for the procedure, 49% were due to contraindication to anticoagulation. Thirty-nine percent had unclear indications: 16% concomitantly received therapeutic anticoagulation, whereas 11% had isolated distal deep vein thrombosis. Mean follow-up was 170 days. Postfilter clinical outcomes included all-cause death in 12%, venous thromboembolism–related mortality in 1%, and PE in 3%. Filter complications occurred in 4%. Retrievable IVC filters were used in 51% with attempted removal in 4%, 3% of which were successful.

The majority of patients receiving IVC filters in our center had strong to moderate indications for the procedure. The use of retrievable filters and consequent retrieval is low and should be encouraged. Venous thromboembolism–related mortality and filter complications were low, comparable to international data.

INTRODUCTION: Maldistribution of echocardiographic expertise is a relevant issue in an archipelago such as the Philippines. We specifically looked at (1) the nationwide census of physician echocardiographers, cardiac sonographers, and cardiac laboratory managers; (2) their geographic distribution; and (3) background training and laboratory classification. METHODS: Data from paper and online surveys conducted in 2015 and 2021 were consolidated alongside the existing society database. Surveys (Google Forms; Google, Mountain View, California) were disseminated through a variety of online, social media, and communication avenues and focused on three categories of respondents: (1) physician echocardiographers, (2) cardiac sonographers, and (3) laboratory managers. The main variables of interest included estimated census per category and geographical distribution. Secondary variables included training background and laboratory classification. RESULTS: In 2021, there were 651 physician echocardiographers, 2487 cardiac sonographers, and 443 cardiac laboratory managers on record, with86 readers, 405 sonographers, and 101 managers responding to the survey. The majority of the surveyed readers (41.2%), sonographers (48.3%), and laboratory managers (28.2%) were situated in the National Capital Region. Close to half of the readers were level III echocardiographers. The majority of the sonographers (46.7%) were nurses, followed by medical technologists (21.8%) and radiologic technologists (18.9%).Most laboratory managers were in nontraining hospitals (38.2%) or stand-alone facilities (20.9%). The minority were in hospitals with cardiology (18.2%) or internal medicine (22.7%) training programs. CONCLUSION Geographical maldistribution of echocardiographic resources is still evident, with the majority of human resources being concentrated in the metropolis. The majority of the sonographers have nursing as their training background, and many laboratory managers are situated in facilities with no established training programs.
echocardiography ; laboratories ; resources ; health resources ; surveys and questionnaires

As a special kind of in vitro diagnostic devices（IVDs）, laboratory developed tests（LDTs） are of great significance to the development of clinical laboratories. This study aims to explore the regulatory requirements ideas of LDTs. By introducing the development of LDTs and the changing of regulatory requirements in the United States, combing the current regulatory framework and discussing relevant ideas in the regulatory requirements of LDTs.
Clinical Laboratory Services ; Laboratories ; Reagent Kits, Diagnostic ; United States ; United States Food and Drug Administration

SARS-CoV-2 has infected more than 600 million people worldwide and caused more than 6 million deaths. The emerging novel variants have made the epidemic rebound in many places. Meteorological factors can affect the epidemic spread by changing virus activity, transmission dynamic parameters and host susceptibility. This paper systematically analyzed the currently available laboratory and epidemiological studies on the association between the meteorological factors and COVID-19 incidence, in order to provide scientific evidence for future epidemic control and prevention, as well as developing early warning system.
Humans ; SARS-CoV-2 ; COVID-19 ; Meteorological Concepts ; Laboratories ; Epidemiologic Studies

Malaria remains a global health challenge, although an increasing number of countries will enter pre-elimination and elimination stages. The prompt and precise diagnosis of symptomatic and asymptomatic carriers of Plasmodium parasites is the key aspect of malaria elimination. Since the launch of the China Malaria Elimination Action Plan in 2010, China has formulated clear goals for malaria diagnosis and has established a network of malaria diagnostic laboratories within medical and health institutions at all levels. Various external quality assessments were implemented, and a national malaria diagnosis reference laboratory network was established to strengthen the quality assurance in malaria diagnosis. Notably, no indigenous malaria cases have been reported since 2017, but the risk of re-establishment of malaria transmission cannot be ignored. This review summarizes the lessons about malaria diagnosis in the elimination phase, primarily including the establishments of laboratory networks and quality control in China, to better improve malaria diagnosis and maintain a malaria-free status. A reference is also provided for countries experiencing malaria elimination.
China/epidemiology* ; Clinical Laboratory Techniques ; Global Health ; Humans ; Laboratories ; Malaria/prevention & control*