Medical imaging examination result quality requirements

Background and Technological Evolution Analysis of Standard Development

The release of DB11/T 2505—2025 "Quality Requirements for Medical Radiographic Examination Results" marks a new stage of standardization and refinement in Beijing's medical imaging quality management. This standard was proposed and managed by the Beijing Municipal Health Commission, and jointly drafted by authoritative units such as Beijing Friendship Hospital affiliated with Capital Medical University and the Beijing Medical Imaging Quality Control and Improvement Center. It was released on December 29, 2025, and is scheduled to be officially implemented on April 1, 2026. Its development stems from the growing core role of medical imaging in clinical diagnosis and the current reality of inconsistent report quality.

With the rapid development of imaging technologies such as DR, CT, and MRI, the amount of image data is growing exponentially. Ensuring the accuracy, standardization, and consistency of massive amounts of examination results has become a key bottleneck in improving the overall quality of medical services. This standard is an important technical specification developed against this backdrop to unify the quality requirements of medical radiological imaging examination results in Beijing and even the Beijing-Tianjin-Hebei region, promote mutual recognition of examination results, reduce duplicate examinations, and ensure patient safety. From a technological evolution perspective, this standard deepens and supplements national industry operating procedures such as WS/T 389 and WS/T 391. For the first time at the local standard level, it systematically extends the "technical operating specifications" of imaging examinations to "result quality requirements," achieving a closed loop from process management to result management. Particularly noteworthy is that the standard actively responds to the national policy guidance on promoting mutual recognition of examination and testing results, innovatively introducing "mutual recognition identification" rules, providing specific technical support for the integration of medical services in the Beijing-Tianjin-Hebei region.

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Core Framework Interpretation: Basic Requirements, Image Quality, and Report Quality

The main content of this standard is built around three core sections: basic requirements, requirements for the quality of radiological imaging examination images, and requirements for the quality of radiological imaging examination reports. These three parts are progressively structured, forming a complete quality control system.

I. Basic Requirements: Laying the Foundation for Quality

Chapter 5, "Basic Requirements," establishes six principles that radiological imaging examination reports should follow: accuracy, completeness, standardization, timeliness, readability, and consistency. These six principles are the gold standard for evaluating all radiological imaging examination results.

The standard clearly stipulates the qualifications for key personnel:

Position	Qualification and Training Requirements	Equipment Operation Authority
Equipment Operators	1. Complete radiation protection training and pass the assessment; 2. Participate in critical value and first aid training; 3. Undergo relevant equipment operation training and master clinical operation procedures.	Technicians and above can independently operate DR; Technicians and above can independently operate CT and MRI.
Report Issuing Physician	Obtain a practicing physician's license and meet one of the following conditions: 1. Pass the first stage of standardized residency training; 2. Obtain the title of attending physician or above.	Have the authority to review and issue final reports.

In addition, the standard mandates the initiation of a critical value reporting process, encourages the use of structured reports, and stipulates that the report review date must be automatically generated by the RIS system and later than the examination time, eliminating logical errors at the source and ensuring the timeliness and traceability of reports.

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II. Requirements for the Quality of Radiological Imaging Examinations: Standardization of Mutual Recognition Marks

Chapter 6 focuses on the quality of the examination images themselves. Besides requiring operators to strictly adhere to technical procedures outlined in standards such as WS/T389 and WS/T391, the biggest highlight lies in the detailed regulations regarding "examination markings," particularly the **mutual recognition markings**. The standard requires that medical institutions within the mutual recognition scope must display the mutual recognition pinyin abbreviation marking after their name on the image:

Beijing Mutual Recognition: Marked as "BJHR"

Beijing-Tianjin-Hebei Mutual Recognition: Marked as "JJJHR"

If the same examination item simultaneously meets multiple mutual recognition scopes, the largest scope (i.e., Beijing-Tianjin-Hebei mutual recognition) should be used for marking.

This regulation provides a clear and unified technical identifier for cross-institutional and cross-regional image data sharing and result mutual recognition, a key measure to promote hierarchical medical treatment and reduce medical costs.

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III. Quality Requirements for Radiological Imaging Examination Reports: The Core of Structure and Precision

Chapter 7 is the essence of this standard, providing detailed regulations for the writing of radiological imaging examination reports. The report content must fully include four major modules: basic information of the examinee, examination technical parameters, image description, and diagnostic conclusion.

1. Scientific and Standardized Image Description

The standard sets extremely high requirements for image description, aiming to eliminate subjective arbitrariness and achieve objectivity, precision, and comparability in the description.

Application Case: Description of Pulmonary Nodules
According to standard 7.4.1.2, the description of a pulmonary nodule must include: location (e.g., apical segment of the right upper lobe), number (single), size (measured length and length, using uniform units), shape (round/lobulated), density (referencing chest wall muscles or blood vessels, graded as slightly high/iso/slightly low), borders (clear/indistinct), enhancement degree (graded as absent/mild/moderate/significant), and surrounding tissue condition (presence or absence of spiculation, pleural retraction). Simultaneously, negative signs with differential diagnostic value must be described, such as "no enlarged lymph nodes seen in the mediastinum and hilum." This structured description provides clinicians with comprehensive and quantitative information, greatly assisting in diagnostic decisions.

The standard specifically emphasizes the **reference system** and **grading terminology**: density/signal intensity must specify a reference tissue (e.g., brain gray matter, liver parenchyma); intensity must use a five-level grading system: "significantly low, slightly low, equal, slightly high, significantly high"; enhancement intensity must use a four-level grading system: "no enhancement, mild enhancement, moderate enhancement, significant enhancement," and explicitly prohibits vague expressions such as "no significant enhancement." 2. Hierarchical and Accountable Diagnostic Conclusions The diagnostic conclusion section requires direct answers to clinical questions and should be arranged in descending order of disease severity. The standard provides clear guidance for qualitative diagnosis:

Imaging features	Diagnostic conclusion requirements	Example
Typical presentation	Give a clear qualitative diagnosis	“Right lobe cavernous hemangioma of the liver”
Atypical presentation	Give probable diagnoses (≤3), in descending order	“1. Possible inflammatory granuloma; 2. Tuberculoma to be ruled out”
Unable to give a probable diagnosis	Give a clear recommendation (such as further examination, consultation)	“It is recommended to perform PET-CT examination for further differentiation”
Follow-up is required for the lesion	Specific follow-up recommendations	“It is recommended to have a follow-up chest CT scan in 3 months”

In addition, the standard requires that imaging staging be given for malignant tumors, and when there are previous examinations, comparisons must be made and the specific comparison time must be noted, reflecting the dynamism and continuity of diagnosis.

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Standard Implementation Recommendations and Challenge Responses

The implementation of DB11/T 2505—2025 will put forward new requirements for the workflow, personnel training and information systems of radiology departments in secondary and above medical institutions. In order to smoothly promote the implementation of the standard, it is recommended that medical institutions take the following measures:

1. Organization and Training System Construction

Immediately establish a special standard implementation team, led by the department director, to organize all physicians and technicians to study the standard provisions, especially the new descriptive specifications and diagnostic conclusion writing requirements.

For new concepts such as "density/signal gradation" and "enhancement gradation," conduct specialized training and image interpretation assessments to ensure consistent understanding and accurate application by all staff.

2. Information System (RIS/PACS) Upgrade

Check if the existing RIS system supports:
- Automatically generate and verify the logical relationship between the report review date and the inspection time (review date later than inspection time).
- Provide structured report templates, embedding the standard-required descriptive fields (such as location, size, density reference, enhancement gradation, etc.) as required or optional items.
- Automatically add compliant "BJHR" or "JJJHR" mutual recognition identifiers in the image printing or export function.
For medical institutions that do not yet meet the requirements, system upgrade or upgrade plans should be initiated as soon as possible.

3. Quality Monitoring and Continuous Improvement

Establish an internal report quality review system based on this standard.

Regularly sample issued reports and score them according to the requirements of completeness, standardization, and accuracy of the standards, and incorporate the results into individual performance evaluations. Establish a "Standard Demonstration Report" column to share excellent cases, correct common errors, and form a quality culture of continuous improvement.

4. Addressing the Challenges of Mutual Recognition

The introduction of mutual recognition marks means that the imaging examination results issued by institutions will be accepted and evaluated on a larger scale. This requires medical institutions to raise their internal quality control standards to the level of regional mutual recognition. In addition to strictly implementing this standard, they should also actively participate in the interlaboratory quality assessment activities organized by the Beijing Medical Imaging Quality Control and Improvement Center to ensure that their own technical level and report quality are in a leading position in the region, thereby winning mutual recognition trust.

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Summary and Outlook

DB11/T 2505—2025 "Quality Requirements for Medical Radiological Imaging Examination Results" is a forward-looking and practical local standard. It has constructed a complete quality control system for medical radiological imaging examination results by refining image identification, standardizing report writing, clarifying personnel qualifications, and introducing a mutual recognition mechanism.

The implementation of this standard will not only significantly improve the quality of imaging diagnostic reports from individual medical institutions in Beijing, but also break down information barriers and optimize the allocation of regional medical resources through standardization and mutual recognition, ultimately benefiting a wide range of patients and promoting the coordinated and high-quality development of medical and health services in the Beijing-Tianjin-Hebei region. All relevant medical institutions should attach great importance to this, plan ahead, and actively implement the standard, transforming its requirements into conscious actions in their daily work, and jointly ushering in a new era of medical imaging quality management.