portant; word-wrap: break-word !important; line-height: 21px; font-family: 宋體; font-size: 14px;">
portant; word-wrap: break-word !important; line-height: 21px; font-family: 宋體; font-size: 16px;">1.相互有影響的儀器設備放置在一起,相互干擾,數據不準;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">2.儀器設備長期不校準/檢定,準確性無保障;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">3.儀器設備不做期間核査,性能不撐控;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">4.儀器設備無狀態標識或標識混亂,容易錯用;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">5.儀器設備無安全保護裝備,對操作員有安全風險;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">6.氣瓶沒有分類貯存,無固定和防漏設施,有爆燃隱患;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">7.儀器設備氣路交叉雜亂,有火災安全隱患;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">8.儀器設備使用無記錄,出現異常無法追溯;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">9.儀器設備檔案信息不全,對維護造成困擾;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">10.儀器設備無強排風裝置,對操作人員有傷害。
portant; word-wrap: break-word !important;">二.實驗室環境控制存在風險
portant; word-wrap: break-word !important; line-height: 21px; font-family: 宋體; font-size: 14px;">
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">1.操作間與儀器間無溫濕度儀,實驗環境條件不清楚;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">2.無“三廢”收集處理裝置,對環境造成威脅;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">3.房間墻壁脫落,地面粗糙不,雜物亂放,臺面凌亂,環境感官不佳,有粉塵污染實驗的危險;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">4.實驗室無強制通風設備,無防火、防水、防腐和急救設施,有人身安全感風險;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">5.廢舊和長期停用設備未清出檢測現場,有誤用風險;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">6.檢測工作時無環境條件記錄,檢測結果無法復現;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">7.微生物學實驗室物流與人流未分開,一更、二更和三更不規范,有交叉污染風險;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">8.致病性微生物實驗室無生物安全裝置,對操作人員有病菌感染風險;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">9.相互有影的工作空間沒有有效隔離,影響檢測結果準確性;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">10.辦公室、檢測室、儀器室混用,相互交叉污染,存在安全隱患和結果準確性風險。
portant; word-wrap: break-word !important;">portant; word-wrap: break-word !important;">三.實驗室標準和標準物質存在風險
portant; word-wrap: break-word !important; line-height: 21px; font-family: 宋體; font-size: 14px;">
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">1.標準無受控編號,標準變更后無法全部追溯變更,有錯用廢舊標準的風險;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">2.標準長時間無查新,標準廢替新發不掌握,有錯用廢舊標準的風險;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">3.廢舊標準無收回或無加蓋“作廢”章,有誤用可能;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">4.現行有效標準沒有購買正式板本,有文本錯誤的可能;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">5.新標準無宣貫記錄,無法保證所有相關人員準確掌握;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">6.新標準啟用無審批程序和記錄,技術負責人責任不到位;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">7.標準物質與其它試劑混存,有交叉污染的風險;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">8.標準物質無期間核查記錄,標準質量不掌控,對檢測結果有影響;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">9.標準物質無法定證書,標準質量不保證,有結果失真風險;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">10.用容量瓶貯存標準物質,有測量準確性下降的風險。
portant; word-wrap: break-word !important;">portant; word-wrap: break-word !important;">四.實驗室化學藥品及耗材存在問題
portant; word-wrap: break-word !important; line-height: 21px; font-family: 宋體; font-size: 14px;">
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">1.沒有合格供應商名錄,耗品質量無保障;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">2.劇毒藥品未實現雙人雙鎖和使用跟蹤監督制度,有劇毒藥品外泄風險;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">3.易制毒藥品未實現雙人雙鎖,有易制毒藥品外泄風險;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">4.試劑藥品無領用登陸記錄,試劑藥品管理不到位;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">5.試劑貯存與操作間同室,對檢驗員健康有害;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">6.試劑瓶標識信息不足,試劑過期失效不掌控;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">7.標準試劑配制時未在恒溫恒濕條件下進行,量具熱漲冷縮,標準溶液無法配準;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">8.批量采購或用量大試劑未再檢驗驗證,試劑不合格會造成巨大損失;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">9.耗材質量無風險分析評估,耗材質量不合格會造成巨大損失;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">10.試劑沒分類貯存,有交叉污染風險,試劑室或試劑柜無強排設施,對操作員健康有害。
portant; word-wrap: break-word !important; line-height: 21px; font-family: 宋體; font-size: 14px;">
portant; word-wrap: break-word !important;">portant; word-wrap: break-word !important;">五.實驗室樣品管理存在十大問題
portant; word-wrap: break-word !important; line-height: 21px; font-family: 宋體; font-size: 14px;">
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">1.樣品編號混亂,無統一唯一性編號,易混淆;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">2.收樣時無進樣品狀態描述和風險評價,出現結果異常無法追溯;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">3.樣品沒有流轉卡,樣品責任不明確;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">4.樣品無待檢、在檢、己檢和留樣狀態標識,有漏檢和重檢的可能;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">5.樣品和留樣無分類貯存和監控,存在交叉污染和霉變風險;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">6.檢畢樣品回收和處置不規范,技術負責人責任不到位;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">7.樣品室與辦公室混用,有安全風險;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">8.樣品處理室與檢測室混用,有交叉污染風險;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">9.樣品貯存無環境監控記錄,有樣品損毀風險;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">10.樣品采集過程中代表性不強,抽樣記錄不祥,影響檢測結果。
portant; word-wrap: break-word !important;">portant; word-wrap: break-word !important;">六.實驗室人員管理存在十大問題
portant; word-wrap: break-word !important; line-height: 21px; font-family: 宋體; font-size: 14px;">
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">1.關鍵崗位人員無任命文件,職權不明確;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">2.檢驗項目無人員上崗證,能力不確認;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">3.各類人員崗位交叉,崗位職責不明確;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">4.關鍵人員無監督計劃或記錄,監控不到位;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">5.技術和管理人員無培訓計劃或記錄,技能不能持續提高;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">6.人員技術檔案與人事檔案混淆,對準則理解不準確;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">7.授權鑒字人職稱和學歷達不到要求,不能擔任該職;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">8.技術負責人職稱學歷達不到要求,不能擔任該職;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">9.檢測人員無大型設備操作證,對設備和結果度不利;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">10.人員的所學專業與從事專業跨度太大,必須繼續教育和考核。
portant; word-wrap: break-word !important;">portant; word-wrap: break-word !important;">七.實驗室檢測報告中存在十大問題
portant; word-wrap: break-word !important; line-height: 21px; font-family: 宋體; font-size: 14px;">
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">1.報告信息量不足,不符合《準則》要求;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">2.報告結論不正確,授權簽字人責任不到位;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">3.報告數據與原始記錄不一致,報告審核人責任不到位;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">4.報告無三級審批簽字,報告管理混亂;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">5.報告格式多變,不嚴肅謹慎;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">6.報告中加蓋的“檢驗檢測專用章”不符合《準則》要求,必須更換;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">7.報告無騎縫章,有報告調換內頁的風險;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">8.報告或原始記錄有不規范的涂改,由作假的可能;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">9.分不清檢驗報告、檢測報告、鑒定報告的區別;
portant; word-wrap: break-word !important; font-family: 宋體; text-indent: 32px; font-size: 16px;">10.報告的發送程序執行不嚴,有涉密風險。