On October 15, the National Health Commission issued the "Notice on Printing and Distributing the Action Plan for Improving the Quality of Tumor Diagnosis and Treatment," further enhancing the quality level of tumor diagnosis and treatment, standardizing diagnosis and treatment behaviors, and ensuring medical quality and safety.

　　Action Plan for Improving the Quality of Tumor Diagnosis and Treatment

　　To implement the decisions and deployments of the Party Central Committee and the State Council, continuously and deeply promote the construction of Healthy China, further improve the quality level of tumor diagnosis and treatment, standardize diagnosis and treatment behaviors, and ensure medical quality and safety, this action plan is formulated.

　　I. Work Objectives

　　From 2021 to 2024, organize and guide local health administrative departments and relevant medical institutions to further strengthen tumor diagnosis and treatment management, and strictly implement relevant laws, regulations, and rules. Promote further improvement in the quality and standardization level of tumor diagnosis and treatment, continuously improve tumor diagnosis and treatment management systems, establish a long-term mechanism for tumor diagnosis and treatment quality supervision, promote high-quality development of tumor diagnosis and treatment services, and safeguard the health rights and interests of the people.

　　II. Promote the Construction of Diagnosis and Treatment Systems and Enhance Tumor Diagnosis and Treatment Capabilities

　　(1) Strengthen the construction of tumor diagnosis and treatment-related specialties. Relevant medical institutions should implement the requirements of the "Notice on Strengthening the Standardized Management of Tumor Diagnosis and Treatment" (Guo Wei Ban Yi Fa [2016] No. 7), and reasonably set up related departments such as oncology, internal medicine, surgery, gynecology, traditional Chinese medicine, radiotherapy, pathology, laboratory, pharmacy, radiology, imaging diagnosis, and nuclear medicine according to the "Basic Standards for Medical Institutions (Trial)" (Wei Yi Fa [1994] No. 30), so that the department layout, equipment configuration, and technical level match the tumor diagnosis and treatment work carried out. Traditional Chinese medicine hospitals with conditions are encouraged to set up oncology departments to carry out tumor diagnosis and treatment work, emphasizing the characteristics of traditional Chinese medicine.

　　(2) Strengthen the construction of professional talent teams. Relevant medical institutions should allocate qualified medical personnel according to tumor diagnosis and treatment needs and increase training efforts. While building the team of physicians in oncology and related surgical departments, strengthen training on tumor medication knowledge, increase the allocation of clinical pharmacists specialized in tumors, and improve the rational use of anti-tumor drugs and related medications; strengthen the allocation and training of pathologists and pathology technicians to improve pathological diagnosis ability and quality; strengthen the allocation and training of nursing staff for tumor patients to provide high-quality nursing services; strengthen the allocation and training of radiotherapy physicians, radiotherapy technicians, and medical physicists to ensure the quality of radiotherapy.

　　(3) Improve the tumor diagnosis and treatment service system. Local health administrative departments should incorporate the tumor diagnosis and treatment system into the construction of hierarchical diagnosis and treatment systems, medical consortiums, and telemedicine service systems, and increase efforts to promote them. Coordinate tumor diagnosis and treatment resources within the jurisdiction, clarify the functional positioning of general hospitals, tumor specialty hospitals, traditional Chinese medicine hospitals, medical testing laboratories, medical imaging diagnosis centers, pathology diagnosis centers, rehabilitation medical institutions, palliative care institutions, and primary medical and health institutions; strengthen cooperation and targeted support; enhance the diagnosis and treatment capabilities of primary medical institutions; establish and improve a medical service system covering the entire cycle and process of tumor diagnosis and treatment; and form a service mechanism featuring technical guidance, vertical and horizontal connectivity, hierarchical diagnosis and treatment, division of labor and cooperation, and integration of traditional Chinese and Western medicine.

　　 III. Optimize Tumor Diagnosis and Treatment Models and Improve Scientific Decision-Making Levels

　　(1) Implement guideline standards and clinical pathways. Medical institutions implementing tumor diagnosis and treatment should strictly follow relevant regulations such as the "Physician Law" and "Regulations on the Administration of Medical Institutions," and strictly implement relevant diagnosis and treatment guidelines (standards), technical operation specifications, and clinical pathways. Based on tumor pathological classification, staging, grading, molecular biological characteristics, and comprehensively considering the patient's basic condition and treatment history, scientifically and reasonably select treatment methods such as surgery, chemotherapy, radiotherapy, biological targeted therapy, and traditional Chinese medicine; formulate and improve detailed and operable specific diagnosis and treatment plans and clinical pathways; and implement standardized diagnosis and treatment.

　　(2) Promote the "single disease, multidisciplinary" diagnosis and treatment model. Medical institutions should implement the "Core System Points for Medical Quality and Safety" (Guo Wei Yi Fa [2018] No. 8), organize discussions on difficult cases, surgeries, and special examinations. According to the requirements of the "Notice on Strengthening the Standardized Management of Tumor Diagnosis and Treatment" (Guo Wei Ban Yi Fa [2016] No. 7), actively promote the concept of "single disease, multidisciplinary" diagnosis and treatment, establish and improve relevant diagnosis and treatment system processes, emphasize multidisciplinary collaboration and the equal importance of traditional Chinese and Western medicine, and improve clinical decision-making levels. Enhance treatment effects through multidisciplinary discussions to formulate comprehensive diagnosis and treatment plans, multidisciplinary joint ward rounds to monitor and evaluate diagnosis and treatment effects and disease progression, and jointly implement related examinations and treatments. Traditional Chinese medicine hospitals should actively promote integrated tumor diagnosis and treatment models of traditional Chinese medicine and multi-professional integrated diagnosis and treatment models, exploring new ideas, methods, and models for the prevention and treatment of tumors combining traditional Chinese and Western medicine.

　　(3) Strengthen informed consent requirements. Medical personnel must strictly implement relevant provisions such as the seventh part of the "Civil Code" and the "Regulations on the Prevention and Handling of Medical Disputes," explain the patient's condition and medical measures to the patient. For surgeries, experimental clinical treatments, clinical trials, special examinations, and special treatments, written consent from the patient or family must be obtained. Medical institutions should strengthen the cultivation of medical personnel's communication skills and awareness to improve communication effectiveness. Implement hospital affairs disclosure requirements by publishing information on medical service items, prices, and medical insurance policies on the official website of medical institutions and in prominent locations within the institutions.

　　IV. Improve Tumor Diagnostic Capabilities and Promote Rational Medical Examinations

　　(1) Strengthen the construction and management of related departments. Relevant medical institutions should strengthen the capacity building of medical imaging, laboratory, and pathology departments to meet clinical needs. Medical institutions conducting related medical examination projects must register according to the "Management Measures for Clinical Laboratories of Medical Institutions" (Wei Yi Fa [2006] No. 73), establish and strictly implement various rules and regulations, strictly comply with relevant technical specifications and standards, strengthen internal quality control and management, participate in inter-laboratory quality assessments, and use inspection and testing equipment and diagnostic reagents that comply with the "Regulations on the Supervision and Administration of Medical Devices" and other regulations. Clinical gene amplification testing laboratories must be managed according to the "Management Measures for Clinical Gene Amplification Testing Laboratories of Medical Institutions" (Wei Ban Yi Zheng Fa [2010] No. 194).

　　(2) Strengthen supervision of medical examinations. Local health administrative departments should prioritize tumor-related medical examinations, explore establishing key monitoring catalogs and abnormal warning systems according to the "Guiding Opinions on Further Regulating Medical Behavior to Promote Rational Medical Examinations" (Guo Wei Yi Fa [2020] No. 29), promptly warn and correct unreasonable medical examination behaviors. Regularly report monitoring of high-value and high-frequency examination projects and link with performance assessments, evaluations, and awards. Medical institutions should establish a suitability evaluation system for large medical equipment examinations, assess indications, necessity, positive rates of examination results, and publicly disclose results within the institution.

　　(3) Standardize the implementation of medical examination projects. Medical institutions should implement medical examinations for patients based on relevant diagnosis and treatment guidelines (standards), clinical pathways, and according to the principle of medical necessity. Medical examination projects with higher risks or lacking support from diagnosis and treatment guidelines (standards) or clinical pathways should have relevant evidence-based medical support and be implemented after departmental discussion. Medical institutions are encouraged to comprehensively consider factors such as risk, medical costs, and evidence-based medicine recommendation levels to classify and manage examination projects, clarifying specific management requirements for different levels of examination and testing projects.

　　(4) Establish and improve the medical examination collaboration mechanism. For medical examination items that the treating medical institution (hereinafter referred to as the treating medical institution) cannot carry out, it is encouraged to implement through the establishment of medical alliances, tumor diagnosis and treatment collaboration groups, or entrusting third parties. When the treating medical institution entrusts or purchases services and sends samples to third-party institutions for medical examinations, it should thoroughly understand their qualifications and capabilities and sign cooperation agreements clarifying the cooperation projects, responsibilities of both parties, as well as sample collection and transportation, fee collection, and result feedback processes. Medical examinations entrusted to third parties must have the informed consent form, examination order (medical advice), and examination results recorded (stored) in the patient's medical record. For public medical institutions entrusting third parties, the related medical examination fees should be collected by the public medical institution. Medical institutions and medical personnel must not induce, suggest, or coerce patients in any form to undergo examinations or treatments at designated locations outside the medical institution for improper benefits.

　 　5. Strengthen tumor medication management and improve the standardization of medication use.

　　(1) Standardize the clinical application of anti-tumor drugs. Medical institutions and medical personnel should follow the "Administrative Measures for the Clinical Application of Anti-tumor Drugs (Trial)" (Guo Wei Yi Han [2020] No. 487) and other regulations, adhere to the principles of safety, effectiveness, and economy, fully consider the clinical therapeutic value, accessibility, and cost-effectiveness of drugs, and use anti-tumor drugs rationally. Priority is encouraged for drugs included in the National Essential Medicines List, the National Basic Medical Insurance Drug List, or those involved in national medical insurance negotiations or bidding procurement. Before using anti-tumor drugs, pathological diagnosis support should be obtained; for drugs with clear target actions, target detection support should be obtained. For tumors difficult to diagnose pathologically, clinical diagnosis can be made based on relevant diagnosis and treatment standards (guidelines).

　　(2) Strengthen the clinical application management of anti-tumor drugs. Medical institutions must strictly implement the "Drug Administration Law" and its implementing regulations, the "Prescription Management Measures" (Ministry of Health Order No. 53), the "Regulations on Pharmaceutical Affairs Management in Medical Institutions" (Wei Yi Zheng Fa [2011] No. 11), the "Standards for Prescription Review in Medical Institutions" (Guo Wei Ban Yi Fa [2018] No. 14), and other relevant regulations and technical standards to strengthen the whole-process management of anti-tumor drugs. Establish a selection and evaluation system for anti-tumor drugs, conduct comprehensive clinical evaluations, closely integrate clinical needs to formulate and regularly adjust the anti-tumor drug supply catalog, and continuously improve the clinical value and supply guarantee capacity of anti-tumor drugs. Strengthen physician prescription authority management, develop a hierarchical management catalog for anti-tumor drugs, and grant corresponding levels of prescription rights based on physician qualifications. Set regulatory indicators scientifically, strengthen clinical application management of anti-tumor drugs through treatment effect evaluation and prescription review, regularly assess and publish application status. Also, actively participate in clinical application monitoring of anti-tumor drugs organized by health administrative departments.

　　(3) Standardize the expanded use of anti-tumor drugs. The clinical application of anti-tumor drugs must follow clinical application guidelines, diagnosis and treatment guidelines (standards), and drug instructions. For drugs without clearly defined indications in instructions, clinical application guidelines, or diagnosis and treatment guidelines but supported by clear evidence-based medicine for certain tumor treatments, expanded use may be conducted under special circumstances where no better treatment options exist. Medical institutions should establish and improve management systems to strictly manage the expanded use of anti-tumor drugs. Expanded use must be discussed by clinical, pharmaceutical, and other relevant experts and approved by the medical institution. Patients or their families must be fully informed about the necessity of medication, medical costs, insurance policies, and risks, and provide written consent.

　　(4) Strictly manage the use of externally purchased drugs. Drugs necessary for clinical diagnosis and treatment but not included in the medical institution's supply catalog should be incorporated into the institution's catalog and procured according to prescribed procedures. For special treatment needs, if drugs outside the institution's catalog must be used, a temporary procurement procedure can be initiated, and the pharmacy department can purchase them temporarily and one-time for use. For urgent clinical needs where procurement cannot be completed in a short time, the clinical department should organize discussions and, after approval by relevant departments of the medical institution, issue prescriptions. Patients or their families must be fully informed about the necessity of externally purchased drugs, medical costs, insurance policies, and risks, and provide written consent. The use of externally purchased drugs must be recorded in medical records. Medical institutions and personnel are strictly prohibited from inducing, suggesting, or coercing patients in any form to purchase drugs at designated locations outside the medical institution for improper benefits.

　　(5) Strengthen the management of key monitored drugs. Medical institutions should develop their own catalogs based on the provincial key monitored rational drug use catalog and publish them according to government and hospital transparency requirements. For drugs included in the catalog, prescription review and evaluation should be strengthened, with results publicly disclosed and feedback provided to further standardize prescription behavior. For drugs with prominent irrational use issues, measures such as ranking notifications, time-limited rectifications, and removal from the institution's drug supply catalog should be taken to ensure rational drug use.

　　6. Strengthen medical technology management and standardize the conduct of clinical trials and clinical research.

　　(1) Establish and improve the clinical application management system for medical technology. Medical institutions should strengthen the clinical application management of medical technology according to the "Administrative Measures for the Clinical Application of Medical Technology" (National Health Commission Order No. 1), establish relevant management systems, formulate and timely adjust the clinical application management catalog for medical technology. The clinical application of tumor diagnosis and treatment-related medical technology should have the required diagnosis and treatment subjects, professional technical personnel, corresponding equipment and facilities, and quality control systems, and comply with relevant technical clinical application management standards. Medical institutions should legally permit medical personnel to implement medical technology appropriate to their professional capabilities and include it in their personal professional technical archives.

　　(2) Standardize the application of restricted medical technology. Medical institutions should establish a demonstration and evaluation system for the clinical application of medical technology. New medical technologies proposed for first-time application must be demonstrated for the institution's technical capability and safety assurance. Restricted medical technologies should be specially evaluated, and based on evaluation results, the institution's management catalog, physician authority grants, and related management requirements should be adjusted timely. Before implementing restricted medical technology on patients, the clinical department should organize discussions, consult relevant departments if necessary, fully inform patients about necessity, medical costs, insurance policies, risks, and alternative options, and obtain written consent before proceeding.

　　(3) Strictly manage clinical trials and clinical research. Prohibited medical technologies, medical technologies with uncertain safety and effectiveness, and unapproved or unregistered drugs and medical devices must not be clinically applied by medical institutions. For in vitro diagnostic reagents without domestic equivalent products on the market, qualified medical institutions may develop and use them according to the "Regulations on the Supervision and Administration of Medical Devices" and other relevant regulations. Medical institutions should strengthen full-process management of clinical trials and clinical research, establish and improve organizational systems, quality systems, and mechanisms to protect the rights and interests of research subjects to ensure scientific, standardized, and orderly conduct. Clinical trials and clinical research must undergo scientific demonstration and ethical review and be approved by the medical institution. The principle of informed consent must be adhered to, and charging patients is strictly prohibited.

　　7. Enrich the connotation of tumor diagnosis and treatment services and strengthen humanistic care.

　　(1) Promote early tumor screening. Local health administrative departments should strengthen system design, formulate and improve screening guidelines for suitable tumor types, clarify safe, effective, and economical screening methods, and promote implementation in conjunction with basic public health services, family doctor contract services, health check-ups, and other initiatives. Extensive training and popular science publicity should be carried out to improve early tumor recognition ability and opportunistic screening levels, promoting early diagnosis and treatment.

　　(2) Ensure the daily diagnosis and treatment needs of cancer patients. Emphasize the daily diagnosis and treatment service needs of cancer patients. Establish and improve the consultation and communication mechanism between departments related to the diagnosis and treatment of basic diseases, comorbidities, and complications of cancer patients and oncology departments. Strengthen the basic knowledge training of medical staff in related departments on cancer diseases, encourage the formation of collaborative groups to address common issues, and jointly provide professional, standardized, and targeted daily diagnosis and treatment services.

　　(3) Pay attention to patients' psychosocial needs. Medical institutions and medical staff should transform the medical model, care about patients' psychological changes, pay attention to their psychosocial needs, and provide psychological support. Encourage medical institutions with conditions to carry out medical social work and volunteer services to help patients in need obtain social resources.

　　(4) Strengthen whole-process management. Enhance health education and follow-up for cancer patients, promote "Internet + medical services," and provide consultation and guidance on cancer medication, complications, and precautions. Integrate the concept of palliative care into the entire cancer diagnosis and treatment process, choose appropriate treatment methods, strengthen functional rehabilitation, long-term care, and nutritional support, improve awareness and level of cancer pain control, promote hospice care, and improve the quality of life of cancer patients.

　　(5) Conduct popular science publicity. Local health administrative departments and medical institutions should increase efforts in popular science education, popularize knowledge on cancer prevention and treatment, objectively and truthfully publicize diagnosis and treatment effects, and guide the public to establish correct and rational views on health and life. Focus on publicity related to laws, regulations, and management requirements to improve cancer patients' and their families' awareness of policies and ability to identify false advertising and illegal diagnosis and treatment behaviors. Strictly implement relevant regulations on medical advertising; false advertising, exaggeration of effects, and inducement of examinations and treatments are prohibited.

　　8. Strengthen work responsibilities and carefully organize implementation.

　　(1) Strengthen organizational leadership. Local health administrative departments should fully recognize the importance of carrying out actions to improve the quality of cancer diagnosis and treatment and enhance the standardization level of diagnosis and treatment. They should earnestly enhance their sense of responsibility and urgency and implement work with a highly responsible attitude toward people's health. Strengthen organizational leadership, refine policy measures, clarify responsibilities, enforce accountability at all levels, and promote orderly work progress. Provincial health administrative departments should formulate and issue their provincial work plans and deploy implementation by the end of October 2021.

　　(2) Establish and improve management systems. Local health administrative departments should formulate and improve supporting documents in accordance with laws, regulations, departmental rules, and relevant documents to guide medical institutions in establishing and improving relevant system norms and strengthen daily supervision. Focus on this action plan to develop and improve consultation discussion systems, management systems for expanded application of anti-tumor drugs, cooperation systems between medical institutions and third parties, clinical application management systems for restricted medical technologies, clinical trial and clinical research management systems, etc., further concretizing and detailing related management requirements and work processes. Local health administrative departments should guide relevant medical institutions to formulate and improve related system norms by the end of 2021.

　　(3) Conduct training and guidance. Local health administrative departments and medical institutions should increase training and assessment efforts related to cancer diagnosis and treatment, regularly conduct relevant knowledge and skills training, and include them in the regular assessment of physicians involved in cancer diagnosis and treatment. Training and assessment content includes laws and regulations related to cancer diagnosis and treatment management, departmental rules, normative documents, diagnosis and treatment guidelines (standards), clinical pathways, medication guidance principles, etc. Local health administrative departments should fully utilize professional teams, establish expert committees for cancer diagnosis and treatment management, and carry out professional training, technical guidance, peer review, and more. The National Health Commission will cooperate with the National Administration of Traditional Chinese Medicine to establish an expert committee for cancer diagnosis and treatment management to provide technical guidance and support nationwide.

　　(4) Strengthen supervision. Local health administrative departments should prioritize supervision and law enforcement on medical and health institutions conducting illegal cancer diagnosis and treatment, clinical trials, etc., and increase supervision and inspection efforts; treat cancer diagnosis and treatment as a key area of medical management work, organize experts to strengthen quality control and evaluation efforts. Problems found should be continuously tracked, and rectifications urged; illegal acts should be recorded and dealt with seriously according to laws and regulations; negative typical cases should be publicly reported. Fully utilize social supervision, seriously listen to public opinions. For valid problem clues, organize investigation and verification according to relevant regulations.

　　(5) Conduct summary and publicity. Local health administrative departments and relevant military medical units should establish a regular summary reporting system to timely grasp the implementation status of relevant medical institutions within their jurisdiction and provide guidance. Strengthen publicity of the action plan and work achievements to create a good public opinion atmosphere. Focus on discovering advanced practices and typical experiences during work, organize their reference and promotion, promote the formation of institutional arrangements, and further improve the cancer diagnosis and treatment management system.

　　Source: Official website of the National Health Commission

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