缇庡浗
CLIA
鍜?/p>
CAP
璁よ瘉鐨勫尯鍒?/p>
涓�锛庝粈涔堟槸
CLIA
CLIA
鏄?/p>
Clinical Laboratory Improvement Amendments
鐨勭缉鍐欙紝鍗充复搴婃
楠屾敼杩涗慨姝ｈ鍒掋�?/p>
CLIA
瀹為獙瀹や富瑕佹湁涓変釜鏈烘瀯鐩戠锛屽垎鍒槸鍖荤枟淇濋櫓鍜屽尰鐤楄ˉ
鍔╂湇鍔′腑蹇?/p>
锛?/p>
CMS
锛?/p>
銆?/p>
鐤剧梾鎺у埗鍜岄闃蹭腑蹇?/p>
锛?/p>
CDC
锛?/p>
銆?/p>
缇庡浗椋熷搧鍜岃嵂鐗╃鐞嗗眬
锛?/p>
FDA
锛?/p>
銆?/p>
A
锛?/p>
CMS
璐熻矗鎵�鏈夎储鍔＄鐞嗗拰璁″垝鐨勮鏀跨鐞嗭紝鍖呮嫭璁よ瘉鍜屾敹璐广�佹鏌ャ�佹墽
娉曘�佽瘎瀹″拰鍥藉璞佸厤鐨勬壒鍑嗐�?/p>
PT
璁″垝鐨勬壒鍑嗭紝骞跺埗瀹氳鍒欍�?/p>
B
锛?/p>
CDC
璐熻矗鎸囧
CLIA
鐩稿叧鐮旂┒锛?/p>
骞朵负
CMS
鎻愪緵绉戝鍙婃妧鏈敮鎸佸拰鍜ㄨ鏈嶅姟銆?/p>
C
锛?/p>
FDA
璐熻矗瀵逛复搴婂疄楠屽妫�娴嬮」鐩繘琛屽垎绫伙紱绠＄悊鏌愪簺璇婃柇璇曞墏
/
鏉愭枡銆佸疄
楠屽淇℃伅绯荤粺浣跨敤鐨勬煇浜涜蒋浠讹紱骞剁洃绠′綋澶栬瘖鏂瘯鍓傜洅涓婂競銆?/p>
閫氳繃
CLIA
璁よ瘉锛屾剰鍛崇潃涓村簥瀹為獙瀹よ瘯楠岀粨鏋滅殑鍑嗙‘鎬с�佸彲闈犳�у拰鏃舵晥鎬ч兘
灏嗗緱鍒?/p>
CLIA
鍥介檯鏍囧噯鐨勮鍙紝浠庤�屼负鍏舵壙鎺ユ洿澶氫复搴婅瘯楠岄」鐩摵骞抽亾璺�備篃鎰?/p>
鍛崇潃
CLIA
瀹為獙
瀹よ兘
澶熸牴鎹?/p>
甯傚満
鐨勭幇
瀹為渶
姹傦紝鍙?/p>
浠ュ揩
閫熺殑
寮�
鍙?/p>
LDTs(lab
developed
test)
骞朵娇涔嬪湪涓村簥涓婂緱鍒板簲鐢ㄤ互缁欎簣涓村簥鎸囧銆?/p>
鐩墠锛?/p>
缇庡浗鏈夎繎
80%
鐨勫疄楠屽閫氳繃浜?/p>
CLIA
璁よ瘉锛?/p>
CLIA
璁よ瘉鑷粠
1992
骞村疄琛屾潵锛岀洰鍓嶅叏缇庢湁
23.2
涓?/p>
瀹跺疄楠屽鑾峰緱璇ラ」璧勮川銆?/p>
浜岋紟浠�涔堟槸
CAP
璁よ瘉
甯歌鐨?/p>
CAP(
COLLEGE OF AMERICAN PATHOLOGISTS
)
璁よ瘉鏄寚鐢辩編鍥界梾鐞嗗浼?/p>
瀵逛复妫�瀹為獙瀹よ繘琛岀殑璁ゅ彲娲诲姩锛?/p>
璁ゅ彲
渚濇嵁鐨勬爣鍑嗘槸
CAP
鑷繁鍒跺畾鐨勬枃浠?/p>
锛?/p>
涓昏鍙?/p>
鐓т簡缇庡浗涓存涓績
(NCCLS)
鐨勪笟鍔℃爣鍑嗗拰鎿嶄綔鎸囧崡銆?/p>
CAP
鏄笓鐢变复搴婃楠屽瀹跺拰鐥呯悊瀛﹀缁勬垚鐨勮仈鍚堜細锛?/p>
琚叕璁や负鏄尰瀛﹀疄楠屽璐ㄩ噺
淇濊瘉鐨勯瀵艰�呬箣涓�銆?/p>
CAP
鐨勪竴涓噸瑕佸唴瀹瑰氨鏄悜涓栫晫鍚勫湴鐨勫弬涓庡疄楠屽寮�灞曡兘鍔?/p>
楠岃瘉娲诲姩锛?/p>
Proficiency Testing, PT
涔熺О涓哄闂磋川璇勶級
銆傞�氳繃瀹ら棿璐ㄨ瘎鍜屽疄楠?/p>
瀹ゅ疄鍦拌瘎瀹¤繘琛?/p>
CAP
璁よ瘉銆?/p>
CAP
璁よ瘉渚濇嵁鏄?/p>
CAP
鑷繁鍒跺畾鐨勬爣鍑嗭紝鍗宠瘎瀹℃鏌ヨ
鐐?/p>
锛?/p>
CHECKLIST
锛?/p>
,
瀹冧富瑕佸弬鐓т簡
CLIA-88
鐨勬爣鍑嗗拰缇庡浗鐨勬硶寰嬫硶瑙勩�?/p>
CAP
鐨勫闂?/p>
璐ㄨ瘎缁撴灉鏄綔涓哄尰瀛﹀疄楠屽鎵т笟璁稿彲鎴栬璇佺殑渚濇嵁銆?/p>
鐩墠
(2009
骞村簳
)
鍏ㄧ悆宸叉湁
200
澶氫釜鍥藉鍜屽湴鍖虹殑鍏珛鍜岀绔嬪疄楠屽閫氳繃浜?/p>
CAP
璁よ瘉锛屼腑鍥界幇鏈?/p>
11
瀹跺疄楠?/p>
瀹ら�氳繃浜?/p>
CAP
璁よ瘉锛屽叾涓?/p>
4
瀹朵负鍖婚櫌妫�楠岀锛?/p>
7
瀹朵负鍟嗕笟瀹為獙瀹ゃ�?/p>
涓夛紟
CLIA
鍜?/p>
CAP
璁よ瘉鐨勫尯鍒?/p>