Development of Independently Established Medical Imaging Diagnostic Centers and Other Specialized Healthcare Institutions: Interpretation by the National Health and Family Planning Commission

At the end of 2016, the National Health and Family Planning Commission (NHFPC) successively issued the basic standards and management regulations for four categories of independently established medical institutions: medical imaging diagnostic centers, medical laboratory testing facilities, blood purification institutions, and pathology diagnostic centers. Following the release of these regulations, the NHFPC recently published an interpretive report addressing seven key issues of concern to the industry and the public. VCBeat Primary Care & Health (WeChat ID: idaifu) has selected several of these major issues for analysis and presentation.

Under the healthcare reform policies of the Party and the state, the current priority is to shift the focus and resources of medical and health services downward and establish a “gatekeeper” system for health. This constitutes a fundamental solution to meeting the public’s needs for medical consultation and treatment.

Establishing independently set up medical institutions, such as medical testing laboratories, can alleviate the problem of unbalanced resource allocation to a certain extent. Centered on the construction of an urban-rural collaborative healthcare service network, we encourage active participation by social forces and explore a healthcare service system architecture that rationally allocates resources, effectively revitalizes existing assets, and improves the efficiency of resource allocation and utilization. This will promote healthcare provision by non-public entities and help fulfill the commitments made by the Party and the government to safeguard the health of the people.

Moreover, both the “Several Opinions of the State Council on Promoting the Development of the Health Service Industry” and the “Guiding Opinions of the General Office of the State Council on Advancing the Construction of a Tiered Diagnosis and Treatment System” explicitly put forward the reform direction of rationally allocating medical resources, namely to “vigorously develop third-party services and guide the development of specialized medical laboratory centers and imaging centers,” and to “explore the establishment of independent regional medical laboratory institutions, pathology diagnosis institutions, medical imaging examination institutions, sterile supply institutions, and blood purification institutions, so as to achieve regional resource sharing.”

According to preliminary statistics, by the end of May 2016, a total of 323 independent clinical laboratories had been established across 22 provinces, including Beijing and Shanghai (309 of which were privately operated, accounting for 95.7%), completing 460 million medical tests in total. Six pathology diagnostic centers were established in three provinces—Beijing, Zhejiang, and Jiangxi (four of which were privately operated, accounting for 66.7%), completing 2.05 million pathology diagnoses. Nine medical imaging diagnostic centers were set up in five provinces, including Shanghai, Zhejiang, and Jiangxi (eight of which were privately operated, accounting for 88.9%). Fifty-seven blood purification institutions were established in five provinces, including Shandong, Hebei, and Jiangxi (with 100% private operation), performing 247,000 blood purification procedures; the average cost of hemodialysis for patients decreased by 17.3%.

The state has issued basic standards and management specifications for these four categories of independently established medical institutions. These primarily include “baseline” requirements concerning diagnostic and therapeutic specialties, departmental configuration, personnel, premises and facilities, zoning and layout, equipment, as well as rules and regulations.

The Management Specifications clarify the internal management “software” requirements for independently established medical institutions. These primarily encompass institutional management, quality management, safety and infection prevention and control, personnel training and occupational safety protection, as well as supervision and management, constituting the internal management requirements that independently established medical institutions must adhere to.

For example, the Basic Standards for Medical Laboratory stipulate personnel qualification requirements. There must be at least one licensed clinician with a professional title of associate senior level or higher. Each clinical laboratory specialty must have at least five medical laboratory technicians, among whom at least one holds an associate senior professional title or higher, and at least two hold intermediate professional titles or higher. For laboratories conducting next-generation sequencing (NGS) projects, there must be at least one bioinformatics specialist; for those offering genetic testing services related to hereditary conditions, there must be at least one medical genetics specialist.

It also stipulates the minimum standards for premises and facilities, requiring that the usable area of medical rooms account for no less than 75% of the total area. For institutions offering one clinical laboratory specialty, the building area shall be no less than 500 square meters; for those offering two or more clinical laboratory specialties, the building area shall increase by 300 square meters for each additional specialty, and so on.

In accordance with the relevant requirements of basic standards and management specifications, medical imaging diagnostic centers, medical laboratories, and pathology diagnostic centers shall be established and approved by the health and family planning administrative departments at the level of cities divided into districts or above. Blood purification institutions shall be established and approved by the provincial-level or higher health and family planning administrative departments.

Unlike departments established within medical institutions, independently established medical institutions are independent legal entities that bear corresponding legal liabilities independently. The National Health and Family Planning Commission encourages active participation by social forces in establishing such independently set-up medical institutions, promoting their development toward group-based and chain-based models. By introducing social capital and increasing the supply of high-quality resources, it aims to gradually form large-scale healthcare groups, leverage technological advantages, enhance risk resistance during operations, establish standardized and normalized management and service models, and ensure medical safety.

The National Health and Family Planning Commission also requires that, during the approval process for establishment, priority be given to entities that have already achieved scale. Furthermore, independently established medical institutions must form collaborative partnerships with general hospitals at Level II or above within their regions and establish green channels in areas such as emergency care for critically ill patients to ensure patient safety. Finally, independently established medical institutions should fully leverage their high-quality resource platforms to provide services to primary healthcare institutions within their regions, enabling patients to access high-quality, standardized medical services close to home.