The health and Family Planning Commission officially issued two documents: standards and specifications of medical laboratory, and the third-party laboratory ushered in good news


Recently, the medical administration and medical administration bureau of the health and Family Planning Commission announced that the health and Family Planning Commission of the health and Family Planning Commission of the health and Family Planning Commission of all provinces, autonomous regions and municipalities directly under the central government and the Health Bureau of Xinjiang production and Construction Corps issued the basic standards for medical laboratory (Trial) and the management specifications for medical laboratory (Trial), and put forward five requirements for the establishment of medical laboratory.

(1) Five requirements for setting up medical laboratory

1. Setting up medical institutions such as medical laboratory plays an important role in realizing the sharing of regional medical resources, improving the service capacity of grass-roots medical institutions and promoting hierarchical diagnosis and treatment. All provincial health and family planning administrative departments should fully understand the significance of this work, earnestly strengthen organization and leadership, improve supporting policies, and ensure the smooth development of the work.

2. The medical laboratory belongs to a separate medical institution, which is an independent legal entity and bears the corresponding legal responsibilities independently. It shall be set up and approved by the health and family planning administrative department at or above the municipal level divided into districts.

3. Health and family planning administrative departments at all levels shall integrate medical laboratory into the local medical quality control system, strengthen indoor quality control and indoor quality evaluation, and ensure medical quality and medical safety. On the basis of quality control, gradually promote the mutual recognition of inspection results between medical institutions and medical laboratory. Encourage medical laboratory and other medical institutions to establish cooperative relations. On the premise of ensuring biological safety and inspection quality, medical laboratory will provide inspection and inspection services for grass-roots medical and health institutions.

4. Encourage the medical laboratory to form a chain and group, and establish a standardized and standardized management and service model. Priority can be given to the applicant who plans to set up a group or chain medical laboratory.

5. The medical laboratory shall establish a cooperative relationship with the general hospitals above the second level in the region, establish a green channel for the first aid of critically ill patients, strengthen technical cooperation and continuously improve the technical level.

(2) Interpretation of the five requirements

1. To promote graded diagnosis and treatment, we should first improve the testing ability of grass-roots medical institutions. The policy clearly puts forward that independent medical testing centers will play an important role in graded diagnosis and treatment.

2. Clarify the independent legal person status of the medical laboratory center, which is supervised by the provincial health and family planning administration department.

3. Promoting the mutual responsibility of results between independent medical laboratories and hospitals shows that the health and Family Planning Commission recognizes the industry status of independent medical laboratories, and third-party laboratories can directly issue medical inspection reports.

4. The policy encourages the chain and group development of third-party laboratories, and gives priority to approval.

5. The policy encourages the establishment of cooperative relations with general hospitals above level II and provides upward technical support.

In short, the health and Family Planning Commission raised the independent medical laboratory (Testing Center) to the strategic height of "promoting hierarchical diagnosis and treatment downward and providing technical support upward", which shows that the state attaches great importance to the independent medical testing center in China's medical service system. Whether it is to promote the mutual recognition of inspection results between medical institutions and medical testing laboratories, or policies to encourage the chain and group development of third-party laboratories, it is a great benefit for the companies involved. Independent medical laboratories will usher in vigorous development, and more new business models are expected in the future.

(3) Make it clear that prenatal screening and diagnosis projects must have corresponding qualifications

In the article 3 "requirements for personnel" of the basic standards for medical laboratory (Trial) issued this time, it is clearly proposed that the experimental technicians carrying out prenatal screening and prenatal diagnosis projects should have the corresponding qualifications for prenatal screening and diagnosis. There shall be at least one professional technician of bioinformatics analysis to carry out the second-generation gene sequencing project; At least one medical genetics professional shall carry out genetic related gene testing projects.

In the third "safety and infection prevention and control" issued by the "independent medical laboratory laboratory management standard (Trial)", the medical laboratory has carried out special projects such as gene amplification, AIDS detection, prenatal screening and diagnosis, preimplantation genetic screening and diagnosis. It shall pass the examination of relevant departments in accordance with the relevant provisions of the national health and Family Planning Commission.

(4) Basic standards for medical laboratory (Trial)

Medical laboratory refers to the clinical examination of samples from human body for the purpose of providing relevant information of human disease diagnosis, management, prevention and treatment or health evaluation, including clinical blood and body fluid test, clinical chemical test, clinical immune test, clinical microbiological test, clinical cytomolecular genetics test and clinical pathological test, and issue the test results, Medical institutions with independent legal personality.