Article 1 This guide is formulated in accordance with the Law of the People's Republic of China on Practicing Physicians and the Regulations on the Administration of Medical Institutions and other relevant laws and regulations in order to guide and strengthen the standardized construction and management of the Department of Pathology in medical institutions, to promote the development of the discipline of pathology, to improve the level of pathological diagnosis, and to ensure the quality of medical care and medical safety.
Second, medical institutions that have set up pathology departments refer to the construction and management of this guide.
Article III of the medical institutions, the Department of Pathology is an important department of disease diagnosis, is responsible for all kinds of organs, tissues, cells, body fluids and secretions taken from the human body specimens, through gross and microscopic observation, the use of immunohistochemistry, molecular biology, special staining and electron microscopy and other techniques for analysis, combined with the patient's clinical information, to make a pathological diagnosis of the disease. The Department of Pathology should also carry out cadaveric pathology examination.
Article IV of the diagnostic need to take from the human body tissue should be sent to the Department of Pathology in a timely manner according to the requirements of the pathology of the project to send a complete examination.
Article V of the pathology of medical institutions should be centralized, unified management.
Article VI of the administrative departments of health at all levels should strengthen guidance and supervision, medical institutions should strengthen the standardized construction and management of the Department of Pathology to ensure that the Department of Pathology in accordance with the principles of safety, accuracy, timeliness, economy, convenience and protection of patients' privacy, to carry out diagnostic work in pathology. Article VII pathology department shall have its function and task appropriate place, facilities, equipment and personnel and other conditions.
Article VIII of the second-level hospital pathology department should be set up at least specimen examination room, routine technology room, pathological diagnosis room, cytology preparation room and pathological archives; tertiary general hospital pathology department should be set up to receive the studio, specimen storage room, rapid frozen section pathological examination and diagnostic room, immunohistochemistry room and molecular pathology testing room, etc.. Other medical institutions should have a pathology department with its pathology diagnostic program appropriate premises, facilities and other conditions.
Article IX of the Department of pathology staffing and job setup should meet the complete pathology diagnostic process and support the need for security. Among them, physicians shall be equipped with 1-2 persons per 100 beds, and medical institutions undertaking teaching and scientific research tasks shall be appropriately increased. Pathology technicians and auxiliary personnel in accordance with the ratio of 1:1 with physicians.
Article X of the pathology department shall have the appropriate professional and technical personnel shall have the appropriate professional qualifications, and obtain the appropriate professional and technical qualifications.
The physician who issued the diagnostic report of pathology shall have the qualification of clinical practitioner and have the qualification of the professional and technical positions of pathology above the primary level, after the diagnostic pathology professional knowledge training or specialized further study for 1-3 years. Rapid diagnostic pathologist should have intermediate or higher pathology professional and technical qualifications, and more than 5 years of diagnostic experience in pathology reading.
The pathology technician is only responsible for pathology technology, shall not be involved in taking materials, shall not issue a diagnostic report of pathology.
Article XI of the pathology department shall have a medical specialty education and pathology intermediate or above professional and technical qualifications, long-term clinical pathology diagnosis; three hospitals should have a pathology department head of associate degree or above professional and technical qualifications in pathology. Article XII of the pathology department shall establish and improve the rules and regulations, job responsibilities and related technical specifications, operating procedures, and strictly abide by the implementation, to ensure the quality of pathology diagnosis.
Article 13 The Department of Pathology shall strengthen quality control and management, carry out indoor quality control seriously, and designate specialized (part-time) personnel responsible for quality management of pathological diagnosis. Participate in the inter-room quality assessment as required.
Medical institutions should strengthen the quality control and management of pathology, medical, nursing, hospital infection and other management departments should fulfill the daily management functions.
Article XIV of the pathology department shall carry out pathological diagnosis in accordance with the prescribed examination items and technical methods, and shall not carry out the examination items and technical methods that have been discontinued or outside the scope of the regulations. The new examination items and technical methods shall be reported to the administrative department of health for approval in accordance with the regulations.
Article 15 The Department of Pathology shall strengthen the management of pathological diagnostic reports, effectively protect the privacy of patients, and is responsible for the issuance of pathological diagnostic reports to provide explanations.
Article 16 The pathology diagnostic report shall include the following:
(1) pathology number, the name of the department that sent the specimen for examination, the patient's name, gender, age, specimen sampling site, the outpatient medical record number and (or) hospitalization medical record number.
(ii) Gross description, microscopic description (selective) and pathologic diagnosis.
(iii) Other elements to be reported or recommended.
(iv) Signature of reporting physician and time of report.
Article XVII of the pathology diagnostic report should be used in Chinese or international common standardized terminology, and its retention period in accordance with the relevant provisions of the management of medical records.
Article 18 The Department of Pathology shall strengthen the preservation and management of pathological records, of which the preservation period of pathological sections, wax blocks and positive smears shall be 15 years, the preservation period of negative smears shall be 1 year, and the preservation period of tissue specimens shall be 2 weeks after the issuance of the report.
Article 19 The medical institutions shall, in accordance with the relevant provisions of the management of medical records and consultation management, establish a comprehensive system of lending and consultation of pathological slides, smears and other information.
Article 20 The instruments, reagents and consumables used in the Department of Pathology shall comply with the relevant provisions of the state, the need to calibrate the instruments and equipment and auxiliary equipment that have an impact on the results of pathological diagnosis shall be calibrated regularly.
Article 21 The Department of Pathology shall carry out indoor quality control of various technologies or testing programs, and shall promptly find out the reasons and take corrective measures in case of loss of control of quality, and record them in detail.
Article 22 The Department of Pathology shall formulate procedures for the identification, reporting, investigation and treatment of pathological diagnostic errors, identify errors in a timely manner, analyze the reasons for their occurrence, and prevent their recurrence.
Article 23 The Department of Pathology shall establish quality management records, including specimen receipt, storage, processing, pathological diagnosis, report issuance, as well as reagents, consumables, instrument use and calibration, indoor quality control, inter-room quality assessment results. The retention period of quality management records shall be at least 2 years. Article 24 The Department of Pathology shall strictly implement the Fire Services Law of the People's Republic of China, the Prevention and Control of Occupational Diseases Law of the People's Republic of China, the Regulations on the Safe Management of Hazardous Chemicals, the Regulations on the Protection of Labor in Workplaces Using Poisonous Substances, the Regulations on the Management of Biosafety of Laboratories for Pathogenic Microorganisms, the General Requirements for Laboratory Biosafety, and the General Guidelines for Biosafety of Microbiological and Biomedical Laboratories. General Guidelines for Biosafety in Microbiological and Biomedical Laboratories" and other regulations to do a good job in the management of hazardous chemicals and biosafety.
Article 25 The Department of Pathology shall provide staff with safety education before starting work and regular training on hazardous chemicals and biosafety protection.
Article 26 The Department of Pathology shall be equipped with the necessary safety equipment and personal protective equipment in accordance with the level of biological protection, to ensure that the staff can be properly used.
Article 27 The architectural design of the pathology department shall comply with the relevant standards, and its hazardous chemicals, biosafety protection level appropriate.
Article 28 The pathology department shall, in accordance with the relevant provisions of the Ministry of Health to do a good job and strengthen the prevention and control of damage to harmful samples.
Article 29 The Department of Pathology shall properly dispose of medical waste in accordance with the "Regulations on the Management of Medical Waste" and "Measures for the Management of Medical Waste in Healthcare Institutions" and the relevant provisions of hazardous chemical liquids.
Article 30 The pathology department shall formulate preventive measures and emergency plans for biosafety accidents and accidents involving hazardous materials and facilities. Article 31 The administrative department of health may set up clinical pathology quality control center or other relevant organizations on the quality and safety management of medical institutions within the jurisdiction of the pathology department for quality assessment and inspection guidance.
Article 32 The medical institutions shall cooperate with the inspection and guidance carried out by the administrative department of health and its commissioned pathology quality control centers or other organizations, and shall not refuse or obstruct or provide false materials. Article 33 This guide shall be interpreted by the Ministry of Health.
Article 34 The Guidelines shall be implemented from the date of publication.