Medical network - October 20 medical inspection room is one of hot topic of clinical classification, and from various provinces and cities planning commission since this year the new approved list of medical institutions, the third party also accounted for most medical inspection room, no problem of large medical equipment production and sales market!
So, the state what is the basic requirement of medical inspection room? Medical device companies want to do medical checkout room business, and should begin from what kind of equipment?
On October 18, national health development planning commission issued the medical test laboratory basic standard (try out) "and" medical test laboratory management standard (trial) ", is to carry out the medical test laboratory setting work put forward specific requirements.
Medical checkout room needed medical equipment list view
In accordance with the basic standard (trial) "medical test laboratory, department of medical inspection room set should include: clinical blood and body fluids inspection professional, clinical chemistry specialty, clinical immunology examination, clinical microbiological professional, clinical cell and molecular genetics and clinical pathology majors, etc. Have medical record information, reagents, quality and safety management, and other special departments or full-time staff, and auxiliary examination departments and disinfection supply room (can be set up also can entrust other medical institutions to undertake the corresponding service).
And medical inspection room equipment configuration, basic equipment, pathological diagnosis should include three parts of equipment, information equipment.
(a) basic equipment.
Including refrigerator, washer centrifuge, and the pressure steam sterilizer, biological safety cabinet and other basic equipment, should be adapted to the inspection items and the workload.
All test equipment, such as biochemical analyzer, blood cell analyzer, urine analyzer, enzyme standard instrument, luminescence analyzer, bacterial culture and identification instrument, nucleic acid analyzer, mass spectrometry, chromatographic analyzer and other inspection equipment should comply with the published by the state food and drug supervision and administration bureau of medical equipment management requirements.
(2) the pathologic diagnostic equipment.
Centrifuge, pipette, specimens of disinfection equipment, biological safety cabinet, cabinet, slicing ark, wax block ark, general photography equipment, the digital section system, optical microscope and other conventional equipment configuration number corresponds to a business.
At least a total of at least five members of the microscope.
Configuration corresponding number of pathological diagnosis and molecular technology and equipment, such as PCR chamber and the corresponding equipment, nucleic acid extraction, molecular hybridization, low temperature centrifuge, fluorescence microscope, etc.
Professional pathology equipment includes closed automatic dewaterer, wax block embedding machine, HE spread out automatic dyeing machine, machine, paraffin wax slice machine, automatic liquid/thin layer cell production equipment, frozen section machine (optional), automatic immunohistochemical dyeing machine, etc., professional pathology equipment should be "the feed drug safety menace level of medical device registration number.
(3) the information equipment.
Have information submitted and transfer function of the network computer equipment, such as specimen management, report management and information management system.
Public hospital clinical laboratory or independence
It is worth noting that 18 who planning commission issued by file also made clear, belong to the separate set of medical institutions, medical test laboratory for the independent legal person unit, independent bear corresponding legal responsibility, set up by the family planning administrative department of public health at the provincial level for examination and approval, and encourage the chaining of formation, the collectivization development.
File above medical test laboratory and secondary general hospital are encouraged to establish cooperation relations, and provide inspection services for basic medical and health institutions.
File also points out that setting medical test laboratory and other medical institutions to implement regional health resource sharing, improving the capacity of grassroots medical institutions service, promote grading diagnosis plays an important role.
That is to say, who the basic standards and specifications of the planning commission file is for as medical test laboratory of the existence of "independent legal person", namely a third party medical institutions, rather than the existing public medical institution of the inspection department, or outsourcing department.
At the same time, the health development planning commission this file, in fact, for medical institutions "area between the mutual recognition of test results were" provides technology and laws and regulations on the protection.
Although for now, all newly approved medical checkout room set in the majority with business or social capital of building, but the analysis thinks, who planning commission file is also in the "mutilated" public hospitals, curb the expansion of the unreasonable, the future of public hospital inspection department, or will be a lot of independence.
Make public hospital clinical laboratory "independent legal person", the unified quality control links, also independently bear legal responsibility, more conducive to promoting mutual recognition ", "test results. The move, but can also avoid patients in different hospital do unnecessary repeated examination, and lower the operating costs of the public hospital clinical laboratory, etc.
To sum up, the independent clinical laboratory, the classification of diagnosis and treatment, and go to town government reform, public hospital will have far-reaching impact.
However, at the same time, some clinical laboratory doctor realize oneself lose the establishment and the "iron rice bowl". |
