Objective To analyze a case of violations by an occupational medical examination (OME) institution and to explore the key control points for the supervision and management of OME institutions, as well as the core role of quality assessment in this context. Methods An OME institution suspected of illegal activities was used as the study subject. Retrospective analysis was conducted. Clues of suspected violations were identified by an on-site quality assessment. After investigation and verification by the local health authorities, legal action was taken against the institution for its violations. Results During an on-site quality assessment, the Guangdong Province OME quality control expert group discovered that the OME institution violated regulations, including unqualified personnel file, exceeding the scope of services category, issuing false reports, failing to report suspected occupational diseases on time, and failing to notify workers about suspected occupational diseases as required. The evidence was then submitted to the Guangdong Province OME Quality Control Center, which subsequently forwarded the case to local health administration department for filing and investigation. After the investigation, penalties were imposed on the OME institution for its illegal activities. Conclusion The key supervision and inspection points in the quality assessment of OME institutions include personnel file configuration, the quality control management system and its implementation, the quality of OME reports, and information reporting. Quality assessment plays a pivotal role in ensuring the legal and compliant practice of OME institutions, safeguarding the health rights and interests of workers, and enhancing the overall standard of the OME industry.

Objective To understand the instrument distribution and capacities of inter-laboratory comparisons among occupational medical examination (OME) institutions in Guangdong Province. Methods A total of 291 OME institutions in Guangdong Province that were within the validity period of filing in June 2024 and 101 OME institutions that participated in inter-laboratory comparisons in 2023 were selected as the study subjects. Their filing categories, instrument distribution and external quality assessment in laboratories were collected and analyzed. Results The location of 291 OME institutions distributed in 21 prefectural-level cities in the province, mainly in the Pearl River Delta (PRD) region, accounting for 68.4% of the total. The public hospitals, private medical institutions, the center for disease control and prevention and occupational disease prevention and treatment institutions (hereinafter referred to as "occupational prevention institutions") accounted for 61.2%, 28.5% and 10.3%, respectively. The filing rates for physical factors, chemical factors, and dust categories among OME institutions were 91.1%, 86.9%, and 86.6%, respectively. The average number of institutional instruments, from high to low, was 53.8, 38.8 and 38.2 per unit in occupational prevention institutions, private medical institutions and public hospitals, respectively. The passing rates of inter-laboratory comparisons among OME institutions of external quality assessment in laboratories among OME institutes in Guangdong Province, from high to low were occupational prevention institutions, public hospitals and private medical institutions (96.2% vs 86.8% vs 73.0%, P<0.05). Conclusion The regional distribution of OME institutes in Guangdong Province is unbalanced, mainly concentrated in the PRD region. Low overall level of OME capacity is found in public hospitals and private medical institutions. Leading by the occupational prevention institutions, public hospitals and private medical institutions should strengthen the development and investment in OME hardware, in order to improve the OME level.

Objective To analyze the risk factors and effective predictive indicators for postpartum hemor-rhage(PPH)in pregnant women with severe pre-eclampsia(sPE)in singleton pregnancies.The findings will serve as a valuable reference for the clinical prevention and management of PPH in these patients.Methods A retrospective analysis was conducted on 932 pregnant women with sPE at two tertiary hospitals in Guangzhou from January 1,2016,to December 31,2022.Among these,95 cases were complicated by PPH.A comparative analysis was performed between the sPE group and the sPE with PPH group.Results(1)The incidence of assisted reproductive technology,intrapartum blood loss,placental abruption,elevated D-dimer levels,increased monocyte counts,and higher SIRI levels were significantly higher in the PPH group,whereas platelet counts were significantly lower(P<0.05).(2)The results indicated that intrapartum blood loss,D-dimer levels,and platelet counts were inde-pendently associated with PPH in pregnant women with sPE.(3)The area under the curve(AUC)for intrapartum blood loss,D-dimer,and platelet counts were 0.805,0.717,and 0.571,respectively.The optimal cutoff value for D-dimer was determined to be 2.295 μg/mL.The combined AUC for intrapartum blood loss and D-dimer was 0.859.(4)Intrapartum blood loss values were significantly higher in the PPH group for both vaginal delivery and cesarean section(P<0.001).The corresponding optimal cutoff values were 285 mL and 375 mL,respectively.Conclusions Intrapartum haemorrhage,D-dimer levels,and platelet count were identified as independent risk factors for PPH in pregnant women with sPE.Specifically,pregnant women with sPE who experienced blood loss exceeding 285 mL during vaginal delivery or 375 mL during caesarean section,along with a D-dimer level greater than 2.295 μg/mL,demonstrated an increased likelihood of developing PPH.Therefore,it is crucial to enhance clinical monitoring of these relevant indicators in high-risk populations.

Objective To analyze the risk factors and effective predictive indicators for postpartum hemor-rhage(PPH)in pregnant women with severe pre-eclampsia(sPE)in singleton pregnancies.The findings will serve as a valuable reference for the clinical prevention and management of PPH in these patients.Methods A retrospective analysis was conducted on 932 pregnant women with sPE at two tertiary hospitals in Guangzhou from January 1,2016,to December 31,2022.Among these,95 cases were complicated by PPH.A comparative analysis was performed between the sPE group and the sPE with PPH group.Results(1)The incidence of assisted reproductive technology,intrapartum blood loss,placental abruption,elevated D-dimer levels,increased monocyte counts,and higher SIRI levels were significantly higher in the PPH group,whereas platelet counts were significantly lower(P<0.05).(2)The results indicated that intrapartum blood loss,D-dimer levels,and platelet counts were inde-pendently associated with PPH in pregnant women with sPE.(3)The area under the curve(AUC)for intrapartum blood loss,D-dimer,and platelet counts were 0.805,0.717,and 0.571,respectively.The optimal cutoff value for D-dimer was determined to be 2.295 μg/mL.The combined AUC for intrapartum blood loss and D-dimer was 0.859.(4)Intrapartum blood loss values were significantly higher in the PPH group for both vaginal delivery and cesarean section(P<0.001).The corresponding optimal cutoff values were 285 mL and 375 mL,respectively.Conclusions Intrapartum haemorrhage,D-dimer levels,and platelet count were identified as independent risk factors for PPH in pregnant women with sPE.Specifically,pregnant women with sPE who experienced blood loss exceeding 285 mL during vaginal delivery or 375 mL during caesarean section,along with a D-dimer level greater than 2.295 μg/mL,demonstrated an increased likelihood of developing PPH.Therefore,it is crucial to enhance clinical monitoring of these relevant indicators in high-risk populations.

Objective To analyze the problems found in the on-site quality assessment of occupational medical examination (OME) institutions in Guangdong Province. Methods A total of 150 OME institutions were selected as the research subjects from Guangdong Province in 2023 using a random number table method. The on-site quality assessment was conducted by listening to reports, meeting discussion, on-site inspection, data review and human-machine assessment. The relevant assessment results were analyzed. Results Occupational disease prevention and treatment institutes (institutes, centers) and disease control and prevention centers (hereinafter referred to as "occupational prevention institutions"), public hospitals, and private institutions accounted for 8.7%, 51.3%, and 40.0% respectively. The top three categories of registered inspections were physical factors, chemical factors and dust, accounted for 98.0%, 96.7% and 96.0%, respectively, among the 150 OME institutions. A total of 1 063 rectification items were identified, and the average number of rectification items identified per occupational prevention institutions, public hospitals and private institutions was four, six and nine, respectively. The rectification rates of the four modules of quality assessment from high to low were OME work quality control, quality management system, organizational structure, and OME information reporting, accounted for 53.2%, 23.3%, 13.7% and 9.7%, respectively. The coincidence rate from high to low of occupational reporting of noise-exposure, dust-exposure, and other hazard-exposure was 92.5%, 91.1%, and 93.4%, respectively. The on-site failure rate of quality control director, technical director, chief physician, pneumoconiosis film reader, audiometry reader and pulmonary function examination operator accounted for 15.3%, 12.7%, 8.0%, 6.7%, 6.0% and 2.7%, respectively. Institutions capable of conducting registered and partially registered OME accounted for 90.7% and 6.0%, respectively. The five institutions that were unable to conduct registered OME were private institutions. A total of five private institutions were found to be suspected of illegal and irregular activities. Conclusion The problems of OME in the on-site quality assessment of OME institutions in Guangdong Province were mainly quality control. Private institutions had more prominent problems in various aspects. It is necessary to strengthen the training of key personnel such as technical directors, quality control directors, and chief physicians.

ObjectiveTo establish a managing mode for illegal and irregular acts of occupational medical examination (OME) institutions to the requirements of the new situation. Methods The OME institutions from the “Guangdong Province Key Occupational Disease Monitoring and Management Platform” were selected as the study subjects using the judgment sampling method. The clues of suspected illegal and irregular acts of OME institutions were found and submitted to the local health commission for investigation and managed according to the case information monitoring and on-site quality assessment. The OME institutions found to have illegal and irregular acts were filed and investigated according to the national law after investigation and verification. A “follow-up inspection” was conducted on five OME institutions for closed loop management. Results A total of 12 OME institutions were found to have suspected illegal and irregular acts, including seven institutions that did not meet the filing requirements for effective personnel, five institutions that conducted projects beyond the scope without filing to the provincial health authorities within 15 work days from the start of the project, and two institutions that failed to fulfill the obligation of informing and reporting to the health authorities, employers, and workers as required. After submitting relevant clues and evidence to the local health commission for investigation and management, seven institutions were not given penalty, and five institutions were given administrative penalties including two institutions were fined and warned, and three institutions were warned. No illegal or irregular acts were found in the five institutions inspected during the “follow-up inspection”. Conclusion It is beneficial to explore the managing mode of “clue discovery, clue submission, investigation and disposal, follow-up inspection” for OME institutions suspected of illegal and irregular acts, which helps urge OME institutions to work in accordance with laws and regulations and effectively protect the legitimate rights and interests of workers' occupational health.

As the management system of Occupational Medical Examination (OME) institutions is moving to a record-filing model, the traditional management approach might not fulfill the current policy requirements. There is a pressing need for development of high-quality occupational health management system. In this context, the Guangdong Provincial Occupational Health Examination Quality Control Center (hereinafter referred to as the "Provincial Quality Control Center") pioneered the integration of the Performance Excellence Model (PEM) framework into the macro-quality management of OME institutions in Guangdong Province. In light of the current research gaps in the field of macro-quality management for OME institutions, the Provincial Quality Control Center, based on the core principles and standards of PEM, has closely aligned with the professional characteristics of occupational health examinations. The established macro-quality management innovation in OME institutions in Guangdong Province consists of seven dimensions: strategic direction, leadership development, identification of key management subjects, data analysis and management, human resources allocation, process optimization, and the application of quality control outcomes. This system has provided a robust impetus for the ongoing improvement of quality control efforts. The initial implementation of PEM demonstrated notable improvements in macro-quality management for OME institutions. Moving forward, the Provincial Quality Control Center will continue to strengthen the development of key technical personnel, innovate training models, harness the advantages of big data technology, restate and upgrade the system continuously, and refine the macro-quality management mechanisms of OME institutions to ensure that the health rights and interests of workers and employers are effectively safeguarded and enhanced.

Objectives::The aim of this multicenter, prospective, single-arm pilot study (ClinicalTrials.gov number: NCT05040074) was to observe the procedural and 30-day results of the novel transcatheter mitral valve repair system, SQ-Kyrin ?-M Clip (Shenqi Medical, Shanghai, China), in patients with severe mitral regurgitation (MR). Methods::The heart team considered patients from 5 centers in China with clinically significant functional mitral regurgitation ≥3+ despite optimal medical therapy or degenerative mitral regurgitation ≥3+ with high surgical risk as candidates for transcatheter repair. All patients received transcatheter edge-to-edge mitral valve repair under general anesthesia. The primary outcome was technical success, which included all of the following measured at the exit from the catheterization laboratory: (1) absence of procedural mortality; (2) successful access, delivery, and retrieval of the device delivery system; (3) successful deployment and correct positioning of the first intended device; and (4) no emergency surgery or reintervention related to the device or access procedure. The secondary outcomes included all-cause mortality, serious adverse events, device success, and procedural success 30 d after the intervention.Results::From June 2021 to December 2021, 18 patients were enrolled in this study with age (75.7 ± 7.4) years. Fifteen patients had MR 4+, while 3 had MR 3+. Technical success was achieved in all patients, including 6 degenerative mitral regurgitation and 12 functional mitral regurgitation patients. There was no all-cause mortality at 30 d. One patient had single leaflet device attachment within 30 d, which was regarded as a serious adverse event, and the patient was successfully treated with reintervention by implanting another clip. Another patient’s transmitral gradient was 6 mmHg (>5 mmHg), with an effective orifice area of 2.57 cm 2 after the procedure. Sixteen patients had device success and procedural success at 30 d postoperation. Fourteen patients had MR 1+, 3 had MR 2+, and only 1 patient had MR 3 + 30 d after the procedure. Conclusions::The results of this feasibility study showed the efficacy and safety of the SQ-Kyrin ?-M device in the Chinese population with severe MR, laying a solid foundation for a subsequent large-scale confirmatory study.

Objectives::The aim of this multicenter, prospective, single-arm pilot study (ClinicalTrials.gov number: NCT05040074) was to observe the procedural and 30-day results of the novel transcatheter mitral valve repair system, SQ-Kyrin ?-M Clip (Shenqi Medical, Shanghai, China), in patients with severe mitral regurgitation (MR). Methods::The heart team considered patients from 5 centers in China with clinically significant functional mitral regurgitation ≥3+ despite optimal medical therapy or degenerative mitral regurgitation ≥3+ with high surgical risk as candidates for transcatheter repair. All patients received transcatheter edge-to-edge mitral valve repair under general anesthesia. The primary outcome was technical success, which included all of the following measured at the exit from the catheterization laboratory: (1) absence of procedural mortality; (2) successful access, delivery, and retrieval of the device delivery system; (3) successful deployment and correct positioning of the first intended device; and (4) no emergency surgery or reintervention related to the device or access procedure. The secondary outcomes included all-cause mortality, serious adverse events, device success, and procedural success 30 d after the intervention.Results::From June 2021 to December 2021, 18 patients were enrolled in this study with age (75.7 ± 7.4) years. Fifteen patients had MR 4+, while 3 had MR 3+. Technical success was achieved in all patients, including 6 degenerative mitral regurgitation and 12 functional mitral regurgitation patients. There was no all-cause mortality at 30 d. One patient had single leaflet device attachment within 30 d, which was regarded as a serious adverse event, and the patient was successfully treated with reintervention by implanting another clip. Another patient’s transmitral gradient was 6 mmHg (>5 mmHg), with an effective orifice area of 2.57 cm 2 after the procedure. Sixteen patients had device success and procedural success at 30 d postoperation. Fourteen patients had MR 1+, 3 had MR 2+, and only 1 patient had MR 3 + 30 d after the procedure. Conclusions::The results of this feasibility study showed the efficacy and safety of the SQ-Kyrin ?-M device in the Chinese population with severe MR, laying a solid foundation for a subsequent large-scale confirmatory study.

Objective: To analyze the status of occupational medical examination (OME) institutions in Guangdong Province and the critical control points affecting their future development. Methods: A total of 211 OME institutions registered in Guangdong Province were selected as the research subjects. Their current statue was investigated, and the risk assessment of their future development was carried out based on hazard analysis and critical control point theory. Results: The OME institutions were mainly concentrated in the Pearl River Delta, accounting for 72.0%. The public and private medical and health institutions accounted for 70.6% and 29.4% respectively. The filing rates of different OME categories from high to low in the order were physical factors, chemical factors, dust, other, radiation factors, biological factors (P<0.01), and the filing rates were 89.6%, 88.6%, 84.8%, 63.0%, 7.1% and 1.0%, respectively. The rates of excellence in the field assessment from high to low in the order were hearing atlas analysis personnel, lung function examination operators, chest film reading personnel, chief examination physician, technical director, quality director (P<0.01), and the rates of excellence were 49.4%, 26.2%, 20.6%, 10.8%, 8.2% and 4.6%, respectively. A total of 37 institutions did not submit OME information, of which 23 institutions did not carry out OME work after filing. The required diagnosis rate and confirmed diagnosis rate of suspected occupational diseases in 2020 were 34.3% and 55.3%, respectively. In 2021, the detection rate of suspected occupational diseases was only 1.1‰. Among the institutions with biological monitoring records, 64.1% did not participate in external quality assessment program in laboratory, and the unqualified rate of 38 participating institutions was 55.3%. The risk assessment results show that the future development of OME institutions needs to focus on private institutions, institutions that have not reported OME information, institutions that have missed diagnosis and missed reporting of suspected occupational diseases, institutions that have not participated in external quality assessment program in laboratory and core personnel such as quality managers, technical leaders, and main inspection physicians. Conclusion: OME institutions in Guangdong Province show the characteristics of centralized filing category, centralized filing region and centralized filing institution nature. Combined with the potential risks of OME institutional capacity building, it is necessary to implement classified management, strengthen information construction, supervision and management, implement post responsibilities, and promote the high-quality development of OME institutions.