臨床微生物學(xué)實驗室建設(shè)基本要求專家共識一
發(fā)布時間：
2022-12-27
作者：
即用型無菌檢查液體微生物培養(yǎng)基
臨床微生物學(xué)實驗室建設(shè)基本要求專家共識一
目前我國基層實驗室存在儀器設(shè)備簡單陳舊，檢驗質(zhì)量缺乏保證，操作程序不規(guī)范，操作人員沒有受過正規(guī)培訓(xùn)等問題。微生物學(xué)檢驗是臨床檢驗中的"短板"，一些二級醫(yī)院尚未建立微生物實驗室或不能開展必要的檢驗項目。為了規(guī)范臨床微生物學(xué)實驗室硬件和軟件建設(shè)，中華醫(yī)學(xué)會檢驗分會微生物學(xué)組委員和國家衛(wèi)計委臨床檢驗中心專家共同討論制定了本共識。
環(huán)境和設(shè)備
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實驗室面積和環(huán)境
臨床微生物實驗室(以下簡稱微生物室)應(yīng)有足夠的空間進行試驗操作和結(jié)果報告。根據(jù)我國目前的現(xiàn)狀，大多數(shù)微生物室僅從事細菌培養(yǎng)、鑒定和藥敏試驗，建議二級醫(yī)院使用面積最好不低于60 m2，三級醫(yī)院不低于160 m2(如果同時開展感染性免疫檢驗，則面積相應(yīng)擴大)。設(shè)置防蟲紗窗和門禁，并按檢測功能進行相對分區(qū)，如分為標本處理、涂片鏡檢、分離培養(yǎng)、鑒定/藥敏、培養(yǎng)基制備和結(jié)果報告等區(qū)域。三級醫(yī)院應(yīng)有獨立的分枝桿菌和真菌檢測室。實驗室內(nèi)要有充足的照明，宜有適當?shù)慕o排水管道、良好的通風設(shè)施和完善的信息管理系統(tǒng)。
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儀器和設(shè)備
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二級醫(yī)院微生物室必備的儀器設(shè)備有：
生物安全柜、高壓消毒滅菌器、紫外燈、試劑冰箱、低溫冰箱、普通培養(yǎng)箱(至少2個溫度)、顯微鏡、比濁計、燭缸、離心機等。有條件或標本量較多的醫(yī)院應(yīng)配備血培養(yǎng)儀、半自動/全自動微生物分析儀。
2
三級醫(yī)院微生物室必須增加配備的儀器設(shè)備有：
血培養(yǎng)儀、自動微生物分析儀、濁度儀、CO2培養(yǎng)箱、細胞離心機、熒光顯微鏡等。
根據(jù)標本量和所開展的檢驗項目，有條件的微生物室可配備(但不限于)：自動染片機、標本自動接種儀、基質(zhì)輔助激光解吸電離－飛行時間質(zhì)譜儀、基因診斷平臺(包括擴增儀、測序儀等)、冷凍干燥機、化學(xué)發(fā)光儀、酶標儀、洗板機等設(shè)備。
人員資質(zhì)
根據(jù)我國目前的現(xiàn)狀，二級醫(yī)院微生物室至少有固定人員2～3人，建議5人及以上，其中實驗室負責人至少為中級技術(shù)職稱，有臨床醫(yī)學(xué)或檢驗醫(yī)學(xué)專業(yè)學(xué)習(xí)背景，并有在三級醫(yī)院微生物室進修6個月以上的經(jīng)歷和3年以上臨床微生物工作經(jīng)驗，有持續(xù)學(xué)習(xí)的熱情和能力，且每2年至少外出學(xué)習(xí)或進修培訓(xùn)1次。
三級醫(yī)院微生物室至少有固定人員6～8人，建議10人及以上，其中實驗室負責人至少為副高技術(shù)職稱，有臨床醫(yī)學(xué)或檢驗醫(yī)學(xué)專業(yè)本科或以上學(xué)歷，有5年以上臨床微生物工作經(jīng)驗，并有持續(xù)學(xué)習(xí)的熱情和能力，且每年至少外出學(xué)習(xí)或進修培訓(xùn)1次。
進入微生物實驗室工作的人員應(yīng)經(jīng)過專業(yè)技術(shù)、醫(yī)院感染知識和生物安全培訓(xùn)。有顏色視覺障礙的人員不應(yīng)從事涉及辨色的微生物學(xué)檢驗[5]。從事特殊崗位檢驗，如性病、HIV、結(jié)核菌和基因擴增檢驗的人員應(yīng)通過相應(yīng)的崗位培訓(xùn)，并具有上崗資格證。
微生物室專業(yè)組長應(yīng)對新入崗人員進行培訓(xùn)、并定期(至少每6個月1次)對在崗人員進行評估考核。對由多個人員進行的手工檢驗項目(如顯微鏡檢查、培養(yǎng)結(jié)果判讀、抑菌圈測量、結(jié)果報告等)應(yīng)進行人員比對。
檢驗技術(shù)
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二級醫(yī)院必備技術(shù)
重點要求能夠通過染色鏡檢和分離培養(yǎng)等技術(shù)及時發(fā)現(xiàn)標本中所存在的病原菌。
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染色鏡檢：
能夠進行革蘭染色、抗酸染色、墨汁染色和乳酸棉酚蘭染色等，并識別常見病原菌。
2
細菌培養(yǎng)：
能夠采用手工方法或血培養(yǎng)儀對血液及無菌體液進行增菌培養(yǎng)。能夠根據(jù)需要對各類標本進行普通細菌培養(yǎng)、苛氧菌培養(yǎng)(可使用燭缸)、厭氧菌(可使用厭氧袋或厭氧罐)和真菌培養(yǎng)。
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細菌鑒定：
可采用全自動、半自動或手工方法(如編碼方法)對臨床常見的需氧菌、兼性厭氧菌、苛氧菌和酵母菌鑒定到種或?qū)俚乃?；對于厭氧菌可僅報告革蘭染色性和細菌形態(tài)。
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藥敏試驗：
能夠?qū)εR床常見細菌進行規(guī)范化的藥敏試驗，并報告敏感/中介/耐藥結(jié)果。
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免疫學(xué)檢測：
根據(jù)臨床需要和科室工作安排，可進行病原菌抗原或抗體檢測(如肝炎病毒抗原抗體檢測)。
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三級醫(yī)院必備技術(shù)(在二級醫(yī)院基礎(chǔ)上)
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染色鏡檢：
能開展六胺銀染色、免疫熒光染色和其他特殊染色。
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細菌鑒定：
能夠?qū)⒎蛛x的細菌(包括分枝桿菌、常見絲狀真菌、厭氧菌)鑒定到種或?qū)偎健?/span>
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藥敏試驗：
能夠開展苛氧菌、厭氧菌和酵母菌的藥敏試驗。
第二部分見 臨床微生物學(xué)實驗室建設(shè)基本要求專家共識二
The establishment of clinical microbiology laboratory requires the consensus of experts
At present, there are some problems in the basic laboratories in China, such as simple and old equipment, lack of guarantee of inspection quality, irregular operation procedures and lack of formal training for operators. Microbiological testing is a shortcoming in clinical testing. Some secondary hospitals have not established microbiological laboratories or cannot carry out necessary testing programs. In order to standardize the clinical microbiology laboratory hardware and software construction, the inspection of Chinese medical association branch of microorganism group members and the national center for health development planning commission clinical inspection experts together to discuss this agreement.
Environment and equipment
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Laboratory area and environment
The clinical microbiology laboratory (hereinafter referred to as microbiology laboratory) shall have sufficient space for test operation and result report. According to the actuality of our country, most microbial room only engaged in bacterial culture, identification and drug sensitive test, suggested that the secondary hospitals use area of not less than 60 m2, best tertiary hospitals not less than 160 m2 (infectious immune if at the same time to carry out the inspection, expand the area of the corresponding). Insect screens set and the entrance guard, and relative partition according to detection, such as divided into specimen processing, smear microscopy, separation, identification/drug susceptibility, culture medium preparation and result report and other areas. A tertiary hospital should have an independent mycobacterium and fungus laboratory. The laboratory should have adequate lighting, suitable water supply and drainage pipes, good ventilation facilities and perfect information management system.
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Instruments and equipment
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The necessary equipment for the microbiology room of the secondary hospital is:
Biosafety cabinet, high pressure sterilizer, uv lamp, reagent refrigerator, low temperature refrigerator, general incubator (at least 2 temperatures), microscope, turbidimetric meter, candle cylinder, centrifuge, etc. Hospitals with conditions or large sample sizes should be equipped with blood culture apparatus, semi-automatic/automatic microbiological analyzer.
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Equipment must be added to the microbiology room of the tertiary hospital:
Blood culture apparatus, automatic microbiological analyzer, turbidimeter, CO2 incubator, cell centrifuge, fluorescence microscope, etc.
According to the amount of specimen and carried out by the inspection items, conditional microbial room can be equipped with (but not limited to) : automatic specimens of dyeing machine, automatic vaccination, matrix assisted laser desorption ionization time of flight mass spectrometer, genetic diagnosis platform (including amplification and sequencing machine, etc.), freeze dryer, chemiluminescence, enzyme standard instrument, washing machine and other equipment.
Personnel qualifications
According to the actuality of our country, microbial secondary hospital room at least 2 ~ 3 are fixed staff, suggest 5 and above, including lab, at least for the intermediate technical titles, or laboratory medicine is clinical medicine professional study background, and microbes in the third-level hospital room further 6 months or more experience and more than 3 years working experience in clinical microbiology, continuous learning enthusiasm and ability, and every two years out for learning or refresher training at least once.
Level 3 at least fixed microbiology LABS personnel 6 ~ 8 people, Suggestions and above 10 people, including lab, at least for the subtropical high technical title, with bachelor degree or above in clinical medicine or laboratory medicine, at least 5 years working experience in clinical microbiology, and continuous learning enthusiasm and ability, and go out to learn or refresher training at least once a year.
Personnel entering the microbiology laboratory should be trained in professional technology, hospital infection knowledge and biosafety. Persons with color vision disorders should not engage in microbiological tests involving color discrimination [5]. Personnel engaged in special post tests, such as STDS, HIV, tuberculosis and gene amplification tests, should pass the corresponding post training and have the qualification certificate.
The professional team leader of the microbiology room should train new employees and evaluate them regularly (at least once every 6 months). Personnel comparison shall be conducted for manual inspection items carried out by multiple personnel (such as microscopic examination, culture result interpretation, bacteriostat measurement, result report, etc.).
Inspection technology
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Skills required for secondary hospitals
It is important to find the pathogenic bacteria in the samples in time through stain microscopy, separation and culture.
1
Stain microscopy:
Able to perform gram stain, acid stain, ink stain and lactic acid cottonophenol stain, and identify common pathogenic bacteria.
2
Bacterial culture:
Can use manual method or blood culture apparatus to sterilize the blood and sterile fluid. Be able to culture all kinds of specimens with common bacteria, caustic bacteria (canister can be used), anaerobic bacteria (anaerobic bag or anaerobic tank can be used) and fungi as needed.
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Bacterial identification:
Full automatic, semi-automatic or manual methods (such as coding methods) can be used to identify common clinical aerobic bacteria, facultative anaerobic bacteria, caustic bacteria and yeast to the level of species or genera. For anaerobic bacteria, only gram stain and bacterial morphology can be reported.
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Drug sensitivity test:
Ability to conduct standardized susceptibility testing on clinically common bacteria and report sensitive/intermediate/resistant results.
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Immunological detection:
Pathogen antigen or antibody detection (such as hepatitis virus antigen antibody detection) can be carried out according to the clinical needs and the work arrangement of the department.
2
Essential skills for tertiary hospitals (on the basis of secondary hospitals)
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Stain microscopy:
It can carry out hexamethylene-silver staining, immunofluorescence staining and other special staining.
2
Bacterial identification:
Able to identify isolated bacteria (including mycobacterium, mycobacterium mycobacterium, common filamentous fungi, anaerobic bacteria) to species or genus levels.
3
Drug sensitivity test:
It can carry out drug sensitivity tests for caustic bacteria, anaerobic bacteria and yeast.