In 2009, the General Office of the State Ministry of Health on the issuance of the Department of Pathology Construction and Management Guidelines (Trial) Notice, to strengthen the construction of the Department of Pathology, increase personnel, equipment, improve conditions, improve the system, strict management, and gradually establish a standardized Department of Pathology.
Guidelines for the construction and management of the Department of Pathology (for trial implementation)
Chapter I General Provisions
Article 1 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 diagnosis of pathology, to ensure the quality of medical care and medical safety, in accordance with the "People's Republic of China*** and the State Practicing Physicians Act" and the "Regulations for the Administration of Healthcare Institutions" and other relevant laws and regulations, this guide is formulated.
The second set of pathology department of medical institutions 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 a variety of organs, tissues, cells, body fluids and secretions taken from the human body specimens, through the body and microscopic observation, the use of immunohistochemistry, molecular biology, special staining, and analysis of electron microscopy and other technologies, 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 tissues should be sent to the Department of Pathology in accordance with the requirements of the pathology of the project, timely and complete examination.
Article V of the medical institutions should be set up centrally within the Department of pathology, 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.
Chapter II conditions of practice
Article 7 of the pathology department shall have its functions and tasks 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, pathology diagnosis room, cytology preparation room and pathology archives; three-level hospital pathology department should be set up to receive the studio, specimen storage room, rapid frozen section pathology and diagnostic room, immunohistochemistry and molecular pathology testing room. Other medical institutions should have a pathology department with its pathology diagnostic program appropriate places, 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 10 of the Department of Pathology professionals and technicians should have the appropriate professional qualifications, and obtain the appropriate professional and technical qualifications.
Diagnostic pathology report should be issued by a physician with clinical qualifications and more than primary qualifications for professional and technical positions in pathology, diagnostic pathology professional knowledge after 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 can only be responsible for the technical work of pathology, shall not issue a diagnostic report of pathology.
Article XI of the Pathology Department shall have a medical specialty education and pathology intermediate or higher professional and technical qualifications, long-term clinical pathology diagnostic work; tertiary hospitals should be in charge of the Department of Pathology has a deputy high above the qualifications of professional and technical positions in pathology.
Chapter III Quality Control
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 of the quality of diagnostic pathology.
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 newly developed examination items and technical methods shall be reported to the administrative department of health for approval in accordance with the regulations.
Article XV of the Department of Pathology shall strengthen the management of pathological diagnosis report, effective protection of patient privacy, and is responsible for the issuance of pathological diagnosis report to provide explanatory notes.
Article XVI of the pathology diagnostic report shall include the following:
(1) pathology number, the name of the department that sent the specimen, 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 perfect 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 of the Department of Pathology shall carry out indoor quality control of various technologies or testing programs, and shall promptly find out the reasons for the appearance of uncontrolled quality, take corrective measures, and detailed records.
Article 22 The Department of Pathology shall develop procedures for the identification, reporting, investigation and treatment of diagnostic errors in pathology, identify errors in a timely manner, analyze the reasons for them, 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 is at least 2 years.
Chapter IV Safety Management
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 Places of Work Using Toxic Substances, the Regulations on the Management of Biosafety of Laboratories for Pathogenic Microorganisms, the General Requirements on Laboratory Biosafety, and the Regulations on Microbiological and Biomedical Safety. Requirements" and "General Guidelines for Biosafety in Microbiological and Biomedical Laboratories" and other provisions to do a good job in the management of hazardous chemicals and biosafety.
Article 25 of the Department of Pathology shall provide safety education to staff before starting work, and regular training on hazardous chemicals and biosafety protection.
Article 26 of the pathology department shall be in accordance with the level of biological protection with the necessary safety equipment and personal protective equipment to ensure that the staff can be used correctly.
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 Department of Pathology shall formulate preventive measures and emergency plans for biosafety accidents and accidents involving dangerous goods and facilities.
Chapter V Supervision and Management
Article 31 The administrative department of health may set up a clinical pathology quality control center or other relevant organizations to assess the quality and safety management of the pathology department of the medical institutions under the jurisdiction of the quality and inspection and guidance.
Article 32 medical institutions shall cooperate with the health administrative department and its commissioned pathology quality control center or other organizations to carry out the inspection and guidance, shall not refuse and obstruct, and shall not provide false materials.
Chapter VI Supplementary Provisions
Article 33 These guidelines shall be interpreted by the Ministry of Health.
Article 34 The Guidelines shall be implemented from the date of issuance.