Release date:2024-05-16

1. Basic Knowledge of Building a New Laboratory (Siege)

(1) Main technologies: immunohistochemistry, molecular biology, special staining, and electron microscopy, etc

(2) Main target audience: Clinical data of patients, including human organs, tissues, cells, body fluids, and secretions

(3) Independent establishment of legal entity for pathological diagnosis reports;

(4) Excluding the pathology department within medical institutions.

2、 (Xige) Laboratory Layout Design

(1) Pathological Diagnosis Laboratory: Organizational Pathology Room, Cellular Pathology Room, Immunohistochemistry Room, Molecular Pathology Room, etc;

(2) There are specialized departments or dedicated personnel for medical records, information, instrument consumables, laboratory quality control, etc;

(3) If conditions permit, a remote pathological diagnosis department can be set up.

3、 (Xige) Laboratory Personnel Layout

(1) At least 5 full-time practicing physicians with intermediate or higher qualifications.

(2) The person in charge should be a licensed physician with a pathology professional and technical title of associate high or above, and have been engaged in the practice for more than 15 years.

(3) At least 10 people (responsible for pathological histology, cytology, immunohistochemistry, and molecular testing)

(4) At least one person with intermediate or higher professional and technical titles is responsible for pathological technical work.

(5) Laboratory quality and safety management should have intermediate or higher professional technical qualifications and undergo specialized training.

4、 (Xige) Laboratory decoration area requirements

(1) The area of the functional room should not be less than 75% of the total area. For example, if the total area is 1000 square meters, the functional department must occupy 75% of it (1000 * 0.75=750 square meters).

(2) The construction area of the pathology diagnosis laboratory shall not be less than 600 square meters.

(3) The laboratory should have emergency power generation equipment.

(4) The molecular pathology laboratory should be set up in accordance with relevant standards and be suitable for its hazardous chemicals and biosafety protection level.

(5) Set up a temporary storage area for medical waste.

5、 (Xige) Laboratory zoning layout

(1) Pathology business functional area.

① Distinguish between clean and contaminated areas

② Basic functional areas include reception and specimen reception area, specimen preparation area, gross examination and sampling area, tissue dehydration processing area, slice production area, cytology processing area, special staining and immunohistochemistry work area, molecular pathology work area, reagent and consumables storage area, specimen storage area, medical waste processing area, and medical staff office area, as well as film reading and discussion area, library, etc.

③ For remote pathological diagnosis, a remote diagnosis room should also be set up.

(2) Auxiliary functional area. Medical expense settlement, as well as instrument consumables and disinfection supply rooms, etc

(3) Management area. Pathological archives, information, laboratory quality control and safety management department.

6、 (Xige) Laboratory instruments and equipment

① Centrifuge, sampler, disinfection equipment, biosafety cabinet, specimen cabinet, slicing cabinet, wax block cabinet, gross photography device, digital slicing scanning system, optical microscope and other conventional equipment;

② At least one microscope for 5 or more people to view;

③ Molecular pathological diagnostic equipment: such as polymerase chain reaction (PCR) chamber and corresponding equipment, nucleic acid extraction equipment, molecular hybridization instrument, low-temperature centrifuge, fluorescence microscope, etc;

④ Professional pathological equipment: enclosed fully automatic dehydration machine, wax embedding machine, HE fully automatic staining machine, spreading machine, paraffin sectioning machine, automatic liquid based thin-layer cell sectioning equipment, frozen sectioning machine (optional), fully automatic immunohistochemistry staining machine, etc. Professional pathological equipment must have a medical device registration number of "National Food and Drug Administration" level.

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