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blockbuster|The National Health Commission will increase the supervision and random inspection of medical testing laboratories!

2023-04-06 1448

Guide

   

To strengthen public health, Medical and health supervision and law enforcement work, 2023 year 3 moon 29 Issued by the National Health Commission of Japan "Regarding the issuance 2023 Notice on the National Random Supervision and Sampling Plan for the Year" , announced 2023 National Random Supervision and Inspection Plan for the Year. It is pointed out that medical institutions will be affected (Including private medical institutions) , Blood Transfusion Services, Supervise the legal practice of maternal and child health care technical service institutions, Advance oneStep up efforts to promote medical beauty, assisted reproduction, Medical Laboratory Testing, The inspection intensity of medical institutions providing health check ups and other services, Serious investigation and punishment of illegal activities in accordance with the law and regulations.



      one, Supervision and spot check content      

(one) school, public place, Hygiene Management of Domestic Drinking Water Supply Units and Centralized Disinfection Service Units for Tableware and Drinking Utensils;

(two) Employers and occupational health examinations, Occupational disease diagnosis, Implementation of occupational disease prevention and control laws and regulations in radiation diagnosis and treatment institutions; Occupational health technical service institutions, Legal Practice of Radiation Health Technology Service Institutions;

(three) Management of Vaccination in Medical and Health Institutions, Focus on receiving COVID-19 vaccine, store, Vaccination and other situations. Report on Infectious Disease Outbreaks in Medical and Health Institutions, Focus on checking whether the report of COVID-19 infection is concealed, Delayed reporting, False reporting and other situations. Epidemic control of infectious diseases in medical and health institutions, Implementation of disinfection and isolation measures, Medical waste management, Biosafety management of pathogenic microorganisms laboratory;

(four) Production and operation of disinfection products and products related to drinking water hygiene and safety;

(five) medical institution (Including private medical institutions) , Blood Transfusion Services, Legal Practice of Maternal and Child Health Care Technical Service Institutions. Continuously consolidating the achievements of the special governance of prominent problems in the medical beauty industry and cracking down on illegal and irregular behaviors in the application of human assisted reproductive technology, Further increase efforts to promote medical beauty treatments, assisted reproduction, Medical Laboratory Testing, The inspection intensity of medical institutions providing health check ups and other services, Serious investigation and punishment of illegal activities in accordance with the law and regulations.


 two, Supervision and spot check content of medical laboratory

(one) Qualification Management of Medical Laboratory. Has the qualification been obtained and verified as required; Whether to register medical laboratory diagnosis and treatment subjects.

(two) Management of technical personnel. Does it meet the job requirements, Is there a situation where non health technicians are used for medical laboratory work; Is the operation and process of laboratory technicians standardized, Does the detection capability match the received sample.

(three) Management of Instrument and Equipment Sites. Does it meet the job requirements, Whether the procurement channels and quality of testing reagents are qualified.  

(four) Quality control management situation. Does the program meet the relevant requirements, whether to carry outIndoor quality control, Whether to participate in the organization of provincial and above clinical laboratory centers as requiredIndoor quality evaluation; Have those who have participated in the inter room quality evaluation achieved qualified results for two or more consecutive times, Or whether the results after rectification are qualified.

(five) Management of medical certification documents. Whether the issuance of medical certification documents complies with relevant regulations; Whether to issue false certification documents.




 three, Job requirements 

(one) After completing the spot check task, all regions should follow the "Who checks, Who entered it, Who is public" The principle of, Publicize the results of spot checks to the public through the official website in accordance with the law. The information on the spot check results includes: No issues were found during the spot check, Discovered problems and ordered correction, administrative penalty, unable to contact (During the inspection, if the unit has already been closed, etc) wait 4 class. No issues found, Information that has been found to be problematic and has been ordered to be corrected, as well as information that cannot be contacted, should be checked from the date of completion of the inspection task 20 Open to the public within working days, Administrative penalty information from the date of making the administrative penalty decision 7 Open to the public within working days.
(two) Each region should follow the requirements of the plan, Report relevant information on time through the health supervision information system.

   four, Integrated solution for standardized and intelligent construction of medical laboratories   

Senxu Medical is based on AI+5G of AIpha Lab The overall solution for the smart laboratory is developed in accordance with international and domestic industry standards and quality management guidelines, Based on technological innovation technology, Integrating series of intelligent application management software with automation, Combining intelligent hardware, Software and hardware compatibility, Implement data flow, Sample flow, reagent flow, Quality flow, Closed loop linkage of equipment flow and benefit flow throughout the entire process; PC end, IPAD tablet, large screen, smartphone, Synchronize various intelligent devices such as intelligent robots with intelligent application management software, satisfy "the entire process, Comprehensive Quality Management Traceability System" of cGMP requirement. conform to ISO15189 International standards such as medical laboratory accreditation and quality management requirements, Implement clinical laboratory personnel for different levels of medical institutions, machine, material, law, Environmental Integration, standardization, Standardized Management, Visualization and intelligent quality management of the entire process, Including management of reagents and consumables, Personnel Management, Indoor quality control management of quality control products, Real time quality control management of patient data, Indoor quality evaluation, Establishment and operation of quality system, etc. Promote standardization of clinical laboratories in hospitals at all levels, Construction and Development of Standardization and Intelligence System.



Source of this article: National Health Commission


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