Investigation and analysis on the quality of occupational medical examination institutes for radiation workers in Jiangsu, China
Highlight box
Key findings
• There are differences in the distribution and capabilities of radiological occupational medical examination institutes in Jiangsu, China, which are related to their nature.
What is known and what is new?
• In recent years, the number of radiological occupational medical examination institutes has rapidly increased.
• The differences in radiation occupational medical examination institutes have some deep-seated patterns by investigation.
What is the implication, and what should change now?
• The capacity building of relevant institutes needs to be strengthened, and we have put forward some suggestions for this.
Introduction
With the increasingly widespread application of ionizing radiation technology in medical, industrial, and other fields, the number of radiation workers has significantly increased in China. As a result, concerns regarding the occupational hazards of radioactivity have grown, leading to an increase in occupational medical examination institutes for radiation workers. In 2019, China’s departmental regulations underwent a change with the Measures for the Administration of Occupational Medical Examination shifting the management mode of occupational medical examination institutes from administrative licensing to record management. Following this change, the management of these institutes was primarily regulated through quality control measures.
As of March 2023, a total of 109 radiological occupational medical examination institutes have been registered in Jiangsu Province. The stability and development of institutes, as well as the quality of their technical services, are directly related to the health monitoring of the radiation workers (1).
In order to comprehensively understand the current situation of occupational medical examination institutes for radiation workers in Jiangsu Province, and to further improve the inspection level and quality control level of these institutes, Jiangsu Provincial Center for Disease Control and Prevention (CDC) organized this investigation. The investigation plan and quality assessment were formulated according to the requirements of the Law of the People’s Republic of China on the Prevention and Control of Occupational Diseases (2), the Measures for the Administration of Occupational Medical Examination, the Technical Specifications for the Occupational Health Monitoring of Radiation Workers (3,4), and the Quality Control Specifications for Occupational Medical Examination, the investigation plan and the quality assessment were formulated.
It is hoped that through this survey, the current situation of all occupational medical examination institutes for radiation workers in Jiangsu Province can be mastered, the data can be analyzed, and the existing problems and suggestions can be put forward to provide a basis for government departments to strengthen supervision. We present this article in accordance with the STROBE reporting checklist (available at https://jphe.amegroups.com/article/view/10.21037/jphe-24-14/rc).
Methods
Survey subjects
The objects of this survey include all qualified and registered radiological medical examination institutes in Jiangsu Province as of March 2023, a total of 109. No patients were involved in this study. Neither approval from the Ethics Committee nor informed consent from participants was required.
Survey contents
In this study, a cross-sectional study method was adopted to compile a quality assessment checklist. The checklist referred to the items stipulated in a local regulation called the Measures for the Record Management of Occupational Medical Examination Institutes in Jiangsu Province. This regulation clearly divides the requirements of management and technical conditions into six aspects: organization condition, staffing condition, equipment management, workplace condition, quality of reports, and quality management. The inspection experts will score all of the 109 institutes according to the checklist, and the full score shall be 100 points, the passing score is 80 points.
The six aspects of evaluation are as follows:
- Organization condition: this refers to the occupational licensing status of the institute, suitable department setup for work, and sufficient number of staff.
- Staffing conditions: this includes employment qualifications, technical titles, professional abilities and education training of personnel.
- Equipment management: this encompasses adequate equipment for routine health inspection and special radiological inspection as well as maintenance and calibration to meet requirements. In this project, the institutes are specifically required to have detection equipment for analyzing chromosome aberrations and micronuclei. This includes the necessity of having an optical microscope for reading film. It should be noted that in China’s national standards, chromosome aberration and micronucleus analysis are indispensable diagnostic indicators for occupational diseases.
- Workplace condition: this involves ensuring an acceptable environment for carrying out occupational health checks including zoning of sites, ventilation systems, detoxification measures, warning signs and waste disposal procedures.
- Quality of reports: this pertains to evaluating summary report quality along with individual personal examination reports and judgments on worker fitness conclusions issued by the institute.
- Quality management: this covers organizational structure system responsibility emergency plans operation standards daily quality control work at the institute.
Investigation methods and quality control
The first step is to develop the investigation plan and initiate the project with approval from the Jiangsu Health Commission. Subsequently, the Jiangsu CDC is tasked with providing guidance and training for on-site experts, ensuring their proficiency in adhering to a standardized reporting format. A unified approach is employed for recovering the quality assessment checklist, with any logical errors or omissions being addressed through feedback mechanisms. The Epidata 3.1 software is utilized for dual-input by two individuals and two machines, followed by data verification and correction procedures subsequent to a consistency test.
Statistical analysis
After organizing and reviewing the completed on-site checklists, a database was established using Excel 2010 software, and SPSS 26.0 software was utilized for statistical analysis of the data. The measurement data were presented as . An independent sample t-test was employed for indicators with homogeneous variances, while a corrected t-test was used for those with uneven variances. The counting data underwent chi-square testing. A significance level of P<0.05 was applied to determine statistical significance.
Results
Basic information
By March 2023, a total of 109 radiological occupational medical examination institutes had been registered in 13 districted cities of Jiangsu Province. Among these, 58 were private institutes (53.2%) and 51 were public institutes (46.8%). The distribution of medical examination institutes in various cities is presented in Table 1. In terms of regional distribution, Suzhou had the largest number of radiological medical examination institutes, with 25 institutes accounting for 27.52%, followed by Wuxi and Nantong at 13.76% and 11.01% respectively. Zhenjiang had the least number of institutes, with only two representing just 1.83% of the total.
Table 1
| Districted city | No. of mechanisms (composition ratio %) | Mechanism attribute | No. of chromosome aberration analysis institutes (%) | |
|---|---|---|---|---|
| No. of public institutes (%) | No. of chromosome aberration analysis institutes (%) | |||
| Nanjing | 6 (5.50) | 2 (1.83) | 4 (3.67) | 2 (1.83) |
| Suzhou | 30 (27.52) | 10 (9.17) | 20 (18.35) | 3 (2.75) |
| Wuxi | 15 (13.76) | 6 (5.50) | 9 (8.26) | 1 (0.92) |
| Changzhou | 5 (4.59) | 2 (1.83) | 3 (2.75) | 1 (0.92) |
| Xuzhou | 6 (5.50) | 6 (5.50) | 0 | 1 (0.92) |
| Nantong | 12 (11.01) | 4 (3.67) | 8 (7.34) | 0 |
| Lianyungang | 5 (4.59) | 4 (3.67) | 1 (0.92) | 3 (2.75) |
| Huai’an | 8 (7.34) | 5 (4.59) | 3 (2.75) | 0 |
| Yancheng | 6 (5.50) | 4 (3.67) | 2 (1.83) | 0 |
| Yangzhou | 3 (2.75) | 1 (0.92) | 2 (1.83) | 0 |
| Zhenjiang | 2 (1.83) | 2 (1.83) | 0 | 0 |
| Taizhou | 6 (5.50) | 2 (1.83) | 4 (3.67) | 0 |
| Suqian | 5 (4.59) | 3 (2.75) | 2 (1.83) | 1 (0.92) |
| Total | 109 (100.00) | 51 (46.79) | 58 (53.21) | 12 (11.00) |
From a regional perspective, there are a total of 56 institutes located in the south region of Jiangsu (Nanjing, Suzhou, Wuxi, and Changzhou), accounting for over half (51.37%) of the total number across all districts within the province.
The city with the most institutes (Suzhou) has 15 times as many as the city with the least (Zhenjiang). As shown in Table 1, only 12 out of all registered institutions (11.00%) conducted chromosome aberration analysis and micronucleus tests within Jiangsu Province.
Further investigation revealed that all twelve conducting these specific tests were public institutions; no private institute carried out such examinations—indicating significant differences between public and private sectors regarding this aspect (χ2=15.335, P<0.01).
Project assessment
The scores of 109 institutes ranged from 70 to 88 points, with an average score of 79.5 points. Public institutes had an average score of 83.4 points, while private institutes had an average score of 76.1 points. The difference between the two was statistically significant (t=7.955, P<0.05). A total of 66 institutes scored 80 points or higher, accounting for 59.1% of public institutes, while the majority of private institutes (72.1%) scored below 80, as shown in Table 2.
Table 2
| Organization category | Average score () | ≥80 points (household %) | <80 points (home %) |
|---|---|---|---|
| Score of public institutes | 83.4±3.7 | 39 (59.1) | 12 (27.9) |
| Score of private institutes | 76.1±5.6 | 27 (40.9) | 31 (72.1) |
| Total | 79.5±6.1 | 66 (100.0) | 43 (100.0) |
The scores of 109 institutes in the three aspects of personnel conditions, equipment management, and reports’ quality did not reach 80% of the assigned scores, among which the score of reports’ quality accounted for the lowest, as shown in Table 3.
Table 3
| Assessment items | Assigned points | Scores () | Percentage of assigned points (%) |
|---|---|---|---|
| Organization condition | 14 | 11.4±0.9 | 81.6 |
| Staffing condition | 26 | 20.3±4.0 | 78.1 |
| Equipment management | 14 | 11.0±1.4 | 78.5 |
| Workplace condition | 12 | 11.3±0.9 | 94.5 |
| Quality of reports | 18 | 12.2±0.7 | 68.0 |
| Quality management | 16 | 13.2±1.0 | 82.6 |
The statistical analysis of assessment scores from both public and private institutes revealed that public institutes outperformed private institutes in terms of personnel condition, equipment management, and quality management, with statistical significance (P≤0.001). Please refer to Table 4 for further details.
Table 4
| Organization category | Organization condition | Staffing condition | Equipment management | Workplace condition | Quality of reports | Quality management |
|---|---|---|---|---|---|---|
| Score of public institutes | 11.4±0.9 | 17.9±4.2 | 10.2±0.9 | 11.4±0.9 | 12.2±0.6 | 12.9±1.0 |
| Score of private institutes | 11.5±0.9 | 23.0±1.0 | 11.9±1.3 | 11.3±1.0 | 12.3±0.7 | 13.5±0.9 |
| t value | 0.213 | 8.534 | 7.955 | −0.875 | 0.539 | 3.318 |
| P value | 0.83 | <0.001 | <0.001 | 0.38 | 0.59 | 0.001 |
Discussion
The number of radiological occupational medical examination institutes in Jiangsu Province ranks among the top in China. As of March 2022, 109 institutes have been registered in 13 districts. The scores of 109 institutes did not reach 80% of the assigned scores in staffing conditions, equipment management, and reports’ quality, which were the main deduction items. Among them, the quality of reports has the most points deducted. The problems are mainly manifested in the non-standard description of occupational hazard factors in the individual report, the missing part description of positive results of eye crystal examination, incorrect reference values for test items, non-standard main test conclusions (multiple occupational hazard factors), missing signatures of inspectors or auditors, and delayed updating of standards.
In terms of staffing conditions, the Occupational Health Inspection Quality Control Standards (trial) stipulates qualifications for personnel in charge and requirements for personnel training. However, it was found that technical personnel and management personnel in most institutes have not conducted relevant knowledge training regularly. Additionally, some quality managers have demonstrated a poor understanding of the pertinent regulations regarding the diagnosis of occupational diseases. The staffing condition problem is significantly higher in private institutes than public institutes (P<0.001).
Regarding equipment management, only 12 institutes were equipped with chromosome aberration analysis and micronucleus test equipment with an allocation rate of 11.0%. Other institutes lack the testing capacity for chromosome projects and generally outsource these two projects. There are also problems such as incomplete instrument and equipment files; lack status identification; instruments and equipment without required metrology verification and calibration; non-strong inspection equipment without calibration method; and no regular self-calibration.
There are also some common problems in the organization. These include post settings that do not meet requirements and unclear responsibilities. In the workplace, main issues include unreasonable layout of inspection rooms and laboratories, substandard ionizing radiation warning signs, inadequate laboratory ventilation, and insufficient detoxification facilities. Quality management problems mainly consist of non-standard quality management system documents, lack of quality management and supervision records, as well as absence of cause analysis and solution measures for out-of-control samples in the laboratory. It was found that the quality management system of public institutes was superior to that of private institutes, with a statistically significant difference between the two types (P=0.001).
To address these issues identified in this survey, the following improvement suggestions are as follows.
Institute capacity building
It is recommended that private institutes should implement stricter personnel selection processes, enhance the training of professional staff (5), and ensure the high-quality completion of medical examination work. Additionally, it is suggested that institutes should rationally arrange the workplace, standardize the use of instruments and equipment, regularly verify and self-calibrate as required to ensure the accurate operation of the equipment. This will ultimately improve the accuracy of medical examination results.
Improve the equipping rate of key equipment
In the investigation, it was found that the lack of ability to analyze peripheral blood lymphocyte distortion and conduct micronucleus experiments is the primary weakness of private medical institutes. This limitation also hinders their development and competitiveness in the market. It is recommended that these institutes should strive to acquire the chromosome aberration analysis instruments and micronucleus experimental instruments, as well as provide training for personnel with evaluation abilities in order to enhance their comprehensive detection capabilities.
Strengthen the quality control of medical examination reports
In the survey, it was found that there was no significant difference between public and private institutes in the quality of reports. This is because the medical examination report system used by each institute mostly consists of the same company’s software, leading to uniform problems caused by single factors. Therefore, it is suggested to further improve the unified reporting software system. This includes enhancing the comprehensiveness of functions, completeness of indicators, accuracy of information, and timely update of reference values. These improvements will ensure the accuracy and integrity of individual reports and summary reports issued.
Comprehensively improve the quality management system
First and foremost, it is essential to enhance internal capacity building. It is recommended that institutions enhance their internal quality management system, strengthen routine quality management, and conduct annual quality sampling inspections (6). Regularly conducting technical training, ability assessments, and quality evaluations (7,8) is also advised. This includes assessments of testing operation abilities, blind peer reviews of reports, laboratory comparison assessments, and quality control inspections.
Secondly, regulatory authorities should improve regulations, standards, and norms related to occupational health services. They should also provide regular training for professionals and guide institutions in standardizing their services. Furthermore, they should promote comprehensive improvement in the level of medical examinations at institutions from an external perspective.
Conclusions
The results of this survey show that the ability and level of radiological occupational medical examination institutes are constantly improving in Jiangsu Province, China. However, because the marketization of services encourages the entry of new institutes, there are still some differences in the development process of institutes even in the same region. In the subsequent development planning, it is important for the health administration department and local government to pay attention to the distribution of institutes in different areas, ensuring that the capacity of medical examination services matches the number of local radiation workers. Additionally, there is a need to enhance the capacity building of existing institutes and promote resource sharing. Regulatory authorities should improve the assessment management system by clearly defining assessment standards and methods for institutes. Regular theoretical or experimental examinations should be conducted, with unqualified institutes being eliminated based on their results. Ultimately, this will lead to standardization and specialization of institutes.
Acknowledgments
Funding: This study was supported by
Footnote
Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://jphe.amegroups.com/article/view/10.21037/jphe-24-14/rc
Data Sharing Statement: Available at https://jphe.amegroups.com/article/view/10.21037/jphe-24-14/dss
Peer Review File: Available at https://jphe.amegroups.com/article/view/10.21037/jphe-24-14/prf
Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jphe.amegroups.com/article/view/10.21037/jphe-24-14/coif). The authors have no conflicts of interest to declare.
Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. No patients were involved in this study. Neither approval from the Ethics Committee nor informed consent from participants was required.
Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.
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Cite this article as: Zhou Y, Miao Y, Wang J, Chen W. Investigation and analysis on the quality of occupational medical examination institutes for radiation workers in Jiangsu, China. J Public Health Emerg 2025;9:2.
