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      臨床微生物學實驗室建設基本要求專家共識二

      發布時間:

      2022-12-27

      作者:

      限度檢查成品培養基


       臨床微生物學實驗室建設基本要求專家共識二
       
       
      4
      非培養診斷技術:
      根據臨床需求可使用PCR、基因測序、芯片、質譜等技術進行病原菌鑒定/分型/耐藥性檢測和同源性分析。可開展病原體血清免疫學檢測、降鈣素原、真菌-(1,3)-β-D-葡聚糖檢測、真菌半乳甘露聚糖檢測、結核T細胞斑點試驗等項目。
       
      質量和服務
      1
      檢驗前程序
      1
      檢驗申請單的設計和應用:
      由于微生物學檢驗的特殊性,所以檢驗申請單除常規信息外還應包括:標本采集方法(如中段尿、導尿、膀胱穿刺尿等)、采集部位、采集時間、采集前是否已使用抗菌藥物、臨床擬診感染類型和(或)可疑目標菌等信息。
       
      2
      標本采集的指導和培訓:
      通過編寫《微生物標本采集手冊》(供醫護人員使用),《痰、尿、便標本采集和送檢須知》(供患者使用),配合多媒體及視頻宣傳等多種形式進行標本采集方法指導和培訓,提高有價值的標本(如血液和無菌體液)以及合格標本的送檢率,對不合格標本應及時反饋,并根據需要進行溝通和再培訓。
       
      3
      標本運送:
      (1)所有標本均應視為有潛在生物危險,運送過程中應防止溢出;(2)應根據標本中的疑似病原菌選擇適宜的運送培養基和保溫措施;(3)所有標本均應盡快運送(在2 h內),特殊標本(如厭氧培養標本、腦脊液標本)應立即運送。
       
      4
      標本驗收:
      除常規的驗收程序以外,應重點關注:(1)送檢標本的容器是否為無菌、封閉、無泄漏;(2)標本類型是否與申請項目相符合(如痰液標本申請項目為厭氧培養,則為不合格);(3)肉眼觀察標本性質是否合格(如送檢的拭子已干燥,送檢的痰標本為唾液等為不合格);(4)標本送檢時間是否已超過允許范圍。對不合格的標本應及時進行登記和反饋。
       
      2
      檢驗程序
      1
      染色鏡檢:
      (1)能夠根據檢驗申請、標本類型及可疑的病原菌種類選擇正確的染色方法(如懷疑隱球菌性腦膜炎,選擇墨汁染色)。(2)對痰標本應進行涂片革蘭染色,判斷標本質量,觀察細菌分布。(3)至少每周用已知的陽性和陰性質控菌株進行1次質控(若檢測頻率小于每周1次,則在實驗當日進行質控)。
       
      2
      細菌分離培養:
      (1)能夠根據檢驗申請信息、標本類型及可疑的病原菌選擇正確的培養基和培養條件(如培養溫度、氣體環境和培養時間)。(2)每一批培養基(包括自制或購買)均應進行質量和性能驗證(無菌試驗、生長試驗、必要時做生長抑制試驗和生化反應)。記錄培養基制備過程(僅對自制培養基)、生產日期、有效期、外觀和性能驗證結果。應在有效期內使用。(3)能正確判別各類標本在培養基上生長的有意義的結果。(4)需要定量培養的標本(如尿液、肺泡灌洗液)應按要求接種,并進行菌落計數。
       
      3
      細菌鑒定:
      (1)能根據細菌菌落形態和涂片染色結果選擇適當的鑒定試驗項目,并采用適宜的方法將細菌鑒定到種。(2)對細菌鑒定所需要使用的血漿凝固酶、觸酶、氧化酶試驗及診斷性抗血清等至少應在每個實驗當日做陽性和陰性質控。(3)對細菌鑒定所需的其他生化反應試劑至少應在每一批次產品使用前做陰性和陽性質控,并在有效期內使用。
       
      4
      藥敏試驗:
      (1)能根據本單位條件及所檢測的病原菌種類選擇紙片擴散法、稀釋法、濃度梯度擴散法(E試驗)或自動化儀器法進行抗菌藥物敏感性試驗。(2)試驗過程應遵循標準化操作方法或制造商建議進行操作。(3)藥物敏感性試驗結果解釋至少應遵循上一年度CLSI藥敏試驗的判斷標準。(4)使用自動化儀器進行藥敏試驗的實驗室應按制造商的要求進行質控。(5)應定期(至少每1~2年1次)使用最新的CLSI文件標準對儀器的藥敏試驗判斷折點進行評估,僅報告符合文件標準的抗菌藥物藥敏試驗結果,對評估不符合要求(如藥物稀釋度不包括藥敏判斷折點、折點設置錯誤、檢測結果偏離)的儀器應暫停使用,并與儀器供應商溝通。(6)使用紙片擴散法進行藥敏試驗的實驗室應按要求對每一批號的藥敏試驗紙片進行質控,如果質控在控,則改為每周質控1次(若檢測頻率小于每周1次,則應在每個檢測日進行質控)。
       
      3
      檢驗后程序
      能夠對各類標本染色鏡檢和細菌培養鑒定結果進行及時準確的報告,并能進行結果解釋,以及與臨床進行良好的溝通。有檢驗醫師的微生物室,可發出"臨床微生物檢驗診斷報告" 。
       
      對各類標本培養陰性結果應進行規范報告:如血液增菌培養報告"培養5 d無菌生長";膿液、引流液、腦脊液、穿刺液等培養報告"培養××小時無菌生長";咽拭子、痰液等報告"正常菌群生長"或"未分離出致病菌";糞便或肛拭子等報告"未培養出志賀菌、沙門菌"或"未培養出霍亂弧菌"等。
       
      血液、腦脊液、骨髓等無菌體液標本檢出細菌(鏡檢或培養)應分級報告,并按危急值報告和登記。
       
      當鑒定出高致病性病原微生物(如布魯菌、弗朗西斯菌)時,應按相關法規要求進行上報和處理。
       
      短時間(5~7 d)內在同一科室分離出3株或以上同種病原菌,或某種耐藥菌分離率異常增高時應報告醫院感染管理部門。
       
      對藥敏試驗結果應按規定進行審核和報告,應特別關注天然耐藥、罕見耐藥菌株和特殊部位分離的病原菌藥敏試驗結果的審核和報告。
       
      對醫院感染管理規定監測的多重耐藥菌要進行報告和預警。
       
      應定期(至少每年1~2次)對抗菌藥物敏感性試驗結果進行統計分析,并向醫院感染部門和臨床醫師通報。
       
      應參加全國或地區性的耐藥監測。
       
      4
      儀器設備質量控制和性能驗證
      對冰箱、培養箱和水浴箱至少每日觀察并記錄1次溫度;CO2培養箱應每日記錄CO2濃度;紫外燈應每日記錄消毒時間,應定期(每6個月)監測紫外線強度并監測紫外燈消毒的效果。
       
      壓力滅菌器應每次使用化學指示劑,每周使用生物指示劑監測滅菌效果。
       
      細菌濁度儀至少每6個月應進行檢定或校準1次。
       
      生物安全柜的高效過濾器、氣流和負壓等參數,壓力滅菌器的壓力表以及卡尺、溫度計、濕度計、移液器的準確性應定期驗證、檢定或校準。
       
      5
      能力驗證
      按要求參加相應的能力驗證/室間質評。
       
      應對"不滿意"和"不合格"的能力驗證/室間質評結果進行分析并采取糾正和預防措施。
       
      對沒有開展能力驗證/室間質評的項目,應至少每6個月與其他實驗室(或其他試驗方法)進行1次性能比對評估試驗。
       
      生物安全
      臨床微生物室屬于二級生物安全實驗室,應按照相關法規要求進行實驗室設計和管理。
       
      臨床微生物室應定期(至少每年一次)進行生物安全風險評估。
       
      應根據風險評估結果配備必要的生物安全防護設備,如生物安全柜、高壓消毒滅菌器、紫外燈、應急燈、洗眼和噴淋設施。根據所配備的生物防護設備設施和個體防護能力明確規定本實驗室所能開展的檢驗項目。
       
      應根據風險評估結果對檢驗人員進行生物安全防護教育,并配備個人防護裝備和用品(如手套、口罩、帽子、實驗用鞋、防護服、防護眼罩等)。
       
      二級醫院不建議保存菌種(質控菌株和需要進一步確認的臨床菌株除外),三級醫院可以保存非高致病性病原微生物菌種,但應指定專人負責,應有存儲、使用、轉運、銷毀記錄,謹防濫用、誤用。實驗中如遇到疑似高致病性菌(按照《人間傳染的病原微生物名錄》),應立即向上級匯報,不要再進行后續的試驗和標本處理。
       
      對超過規定保存時間的標本和培養物應高壓滅菌后再交保潔人員進行處理,并進行交接記錄。
       
      '針對在試驗過程中可能產生的生物安全意外事故(如針刺傷、皮膚、黏膜或環境污染)應有相應的應急預案和事故記錄。
       
      本文來源:節選自《中華檢驗醫學雜志》
       

      The establishment of clinical microbiology laboratory requires the consensus of experts
       
       
      4
      Non-culture diagnosis technology:
      According to the clinical requirements, PCR, gene sequencing, microarray, mass spectrometry and other techniques can be used for pathogen identification/typing/drug resistance detection and homology analysis. Projects such as pathogen serum immunology detection, calcitonin progenitor, fungal -(1,3)- vacuum-d-glucan detection, fungal galactomannan detection, and tuberculosis t-cell spot test can be carried out.
       
      Quality and service
      1
      Pre-test procedure
      1
      Design and application of inspection application form:
      Due to the particularity of microbiology test, so the inspection application form in addition to the regular information should include: the specimen collection methods (such as urine, urethral catheterization, bladder puncture urine, etc.) in middle and gathering place, have before sampling time, use of antibacterial drugs, infection of clinical examination type and (or) suspicious information such as target bacteria.
       
      2
      Sample collection instruction and training:
      By writing "manual of microbiological specimen collection" (for the use of health care workers), the sputum, urine, stool specimen collection and inspection guidelines "(for the use of patients), with a variety of forms such as multimedia and video propaganda specimen collection method guidance and training, improve the valuable specimens (such as blood and aseptic humoral) and specimens of qualified sampling rate, the unqualified specimens should be timely feedback, and according to the need to communicate and retraining.
       
      3
      Specimen transport:
      (1) all specimens shall be deemed to have potential biological hazards and overflow shall be prevented during transportation; (2) appropriate transport media and heat preservation measures should be selected according to the suspected pathogenic bacteria in the specimen; (3) all specimens shall be sent as soon as possible (within 2 h), and special specimens (such as anaerobic culture specimens and cerebrospinal fluid specimens) shall be sent immediately.
       
      4
      Specimen acceptance:
      In addition to the routine acceptance procedures, attention should be paid to: (2) whether the specimen type is consistent with the application project (if the sputum specimen application project is anaerobic culture, it is unqualified); (3) visually observe whether the specimen is qualified (if the swab is dry and the sputum specimen is saliva, etc.); (4) whether the specimen delivery time has exceeded the allowed range. Unqualified specimens should be registered and feedback timely.
       
      2
      Inspection procedures
      1
      Stain microscopy:
      (1) the correct staining method can be selected according to the test application, specimen type and suspect pathogen species (for example, if cryptococcal meningitis is suspected, ink staining is selected). (2) sputum samples should be stained with smear gram to determine the sample quality and observe the distribution of bacteria. (3) conduct quality control with known positive and negative quality control strains at least once a week (if the test frequency is less than once a week, conduct quality control on the test day).
       
      2
      Isolation and culture of bacteria:
      (1) the right medium and conditions (such as incubation temperature, gas environment and incubation time) can be selected according to test application information, specimen types and suspected pathogenic bacteria. (2) quality and performance verification (aseptic test, growth test, growth inhibition test and biochemical reaction if necessary) shall be conducted for each batch of culture medium (including self-made or purchased). Record the results of the preparation process (for the homemade medium only), production date, expiry date, appearance and performance verification. It should be used within the validity period. (3) meaningful results that can accurately identify the growth of various specimens in the medium. (4) specimens requiring quantitative culture (such as urine and alveolar lavage fluid) shall be inoculated as required and colonies shall be counted.
       
      3
      Bacterial identification:
      (1) appropriate identification test items can be selected according to the bacterial colony morphology and smear staining results, and appropriate methods can be adopted to identify bacteria into species. (2) the plasma coagulase, thixoenzyme, oxidase test and diagnostic antiserum test required for the identification of bacteria shall be subject to positive and negative quality control at least on each experimental day. (3) other biochemical reagents needed for the identification of bacteria shall be used for negative and positive quality control at least before the use of each batch of products and within the effective period.
       
      4
      Drug sensitivity test:
      Can (1) according to its condition and detection of pathogenic bacteria species selection by disc diffusion method, dilution method, the concentration gradient diffusion method (E) or automation instrument method for antibacterial drug sensitivity test. (2) the test process shall follow the standardized operation method or the manufacturer's Suggestions. (3) the interpretation of drug sensitivity test results should follow the judgment criteria of CLSI drug sensitivity test at least last year. (4) laboratories using automatic instruments for drug sensitivity testing shall conduct quality control according to the requirements of the manufacturer. (5) should be regularly (at least once every 1 ~ 2 years) using the latest CLSI file standard of instrument to evaluate the drug sensitive test of judgment fold point, only report file standard antimicrobial susceptibility test results, the assessment does not conform to the requirements (such as drug dilution degrees, not including susceptibility to judge fold point, fold point setting error and deviation of test result) of the instruments used shall be suspended, and communicate with equipment suppliers. (6) using disc diffusion method for drug sensitive test laboratory shall according to the requirements for each batch number of drug sensitive test pieces for quality control, and if the quality control, or quality control 1 times a week (if the testing frequency is less than 1 times a week, should be in each detection, quality control).
       
      3
      Post-test procedure
      It can timely and accurately report the results of staining microscopy and bacterial culture identification of various specimens, interpret the results, and communicate well with the clinic. A microbiological laboratory with an inspector may issue a "clinical microbiological diagnostic report".
       
      The negative results of the culture of various specimens should be reported in a standardized way: for example, the report of blood enrichment culture "sterile growth of culture for 5 days"; Culture reports of abscess, drainage fluid, cerebrospinal fluid, puncture fluid, etc. Pharyngeal swab, sputum and other reports of "normal flora growth" or "unisolated pathogenic bacteria"; Reports of "no shigella, salmonella or vibrio cholerae" in feces or anal swabs.
       
      Bacteria (microscopic examination or culture) detected in blood, cerebrospinal fluid, bone marrow and other sterile humoral specimens shall be classified and reported and registered according to the critical value.
       
      When highly pathogenic pathogenic pathogenic microorganisms (such as brucella and Francis bacillus) are identified, they should be reported and treated in accordance with relevant regulations.
       
      In a short period of time (5 ~ 7 d), 3 strains or more of the same pathogenic bacteria were isolated from the same department, or an abnormal increase in the separation rate of certain drug-resistant bacteria should be reported to the hospital infection management department.
       
      The results of drug susceptibility test should be reviewed and reported in accordance with the regulations. Special attention should be paid to the review and report of the results of drug susceptibility test for pathogenic bacteria isolated from natural drug resistance, rare drug-resistant strains and special sites.
       
      Multiple drug-resistant bacteria monitored in hospital infection management regulations should be reported and warned.
       
      The results of antimicrobial susceptibility tests should be statistically analyzed regularly (at least once or twice a year) and reported to hospital infection departments and clinicians.
       
      Participate in national or regional drug resistance monitoring.
       
      4
      Equipment quality control and performance verification
      Observe and record the temperature of the refrigerator, incubator and water bath at least once a day. CO2 incubator should record CO2 concentration every day. The uv lamp shall record the disinfection time every day, and the uv intensity shall be monitored regularly (every 6 months) and the disinfection effect of the uv lamp shall be monitored.
       
      The pressure sterilizer should use chemical indicator every time and use biological indicator every week to monitor the sterilization effect.
       
      The bacterial turbidimeter should be calibrated or calibrated at least once every 6 months.
       
      Hepa filter, flow and negative pressure of bio-safety cabinets, parameters such as pressure gauge pressure sterilizer and gauge, thermometer, hygrometer, the accuracy of the moving liquid should be regular verification, verification or calibration.
       
      5
      Ability to verify
      Participate in the appropriate competency verification/inter-room quality assessment as required.
       
      Analysis and corrective and preventive actions should be carried out on the results of the "dissatisfied" and "unqualified" capacity verification/interventricular quality assessment.
       
      A performance comparison assessment test should be conducted at least once every 6 months with other laboratories (or other test methods) for projects that do not have capacity verification/interventricular quality assessment.
       
      Biological safety
      The clinical microbiome belongs to the second-level biosafety laboratory and should be designed and managed in accordance with relevant regulations.
       
      The clinical microbiome should carry out biosafety risk assessment regularly (at least once a year).
       
      The necessary biosafety protection equipment such as biosafety cabinet, high pressure sterilizer, uv lamp, emergency lamp, eye washing and spraying facilities should be equipped according to the risk assessment results. According to the equipped biological protection equipment facilities and the individual protection ability clearly define the laboratory can carry out the inspection project.
       
      Should be according to the result of risk assessment on biosafety education inspection personnel, and equipped with personal protective equipment and supplies (such as gloves, mask, cap, experiment with shoes, protective clothing, protective goggles etc.).
       
      Secondary hospitals do not recommend keep (quality control strains and the need to further confirm the clinical strains except), tertiary hospitals can preserve the highly pathogenic strains of pathogenic microorganisms, but should appoint someone who's in charge, storage, use, transfer, destruction of records, beware of abuse and misuse. If any suspected highly pathogenic bacteria are encountered in the experiment (according to the list of pathogenic microorganisms transmitted from human to human), they should report to the superior immediately, and no further test and sample treatment should be conducted.
       
      Samples and culture materials over the specified preservation time shall be sterilized under high pressure and then handed over to the cleaning personnel for treatment and handover records.
       
      'in the event of a potential biosafety accident (such as needle puncture, skin, mucous membrane or environmental pollution) in the course of the test, appropriate contingency plans and incident records shall be made.
       
      Source: Chinese journal of laboratory medicine
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