ࡱ> $& !"#[ zbjbj  ΐΐZ%1)1) , , ,,,,8U,i-,7 5(55"W5W5W5@@@$9<4 ,-BX?@-B-B41)1)W5W5 -BZ^1) W5 ,W5-BX=+W5ЍsM,:(07b(WBP ,n@@h AT^A@@@44 @@@7-B-B-B-B@@@@@@@@@ ': CNG HO X HI CH NGH(A VIT NAM c lp - T do - Hnh phc N NG K KIM TRA  THC HNH TT NH THUC (M MI ) Knh gi: S Y t Lm ng Tn c s : Trc thuc (nu trc thuc cng ty, bnh vin, ) a ch : in thoi : Ngi ph trch chuyn mn : L dc s trung cp  c cp chng ch hnh ngh Chng ch hnh ngh dc s : do S Y t Lm ng cp ngy C s chng ti  ngh S Y t Lm ng kim tra  cng nhn c s chng ti t tiu chun nguyn tc  Thc hnh tt nh thuc Chng ti xin gi km theo bn ng k cc ti liu sau: 1.n ng k kim tra :thc hnh tt nh thuc : 2.Bn sao Giy chng nhn ng k kinh doanh 3.Ba n sao chng chi  hanh ngh 4.Bn k khai c s vt cht trang thit b 5Bn k khai danh sch nhn s va bng cp chuyn mn 6.Bn t kim tra GPP theo Danh mc kim tra quy nh ti Ph lc II Thng t s 46/2011/TT-BYT ngy 21/12/2011. ....,ngy ... thng ....nm 201...  NGI PH TRCH C S CNG HO X HI CH NGH(A VIT NAM c lp - T do - Hnh phc BN K KHAI DANH SCH NHN S V BNG CP CHUYN MN C s kinh doanh: H tn ch c s : S CCHND: a im kinh doanh: T: Phm vi kinh doanh: Bn thuc phng v cha bnh cho ngi STT H v tn Nm sinh a ch thng tr Trnh  chuyn mn Nm tt nghip Ni cp bng Cng vic c phn cng Nam N 1 Ph trch Quy .......,ngy thng nm 2017 Ch c s cam oan khai ng s tht K ghi r h tn    CNG HO X HI CH NGH(A VIT NAM c lp - T do - Hnh phc BN K KHAI A IM V TRANG THIT B CA C S KINH DOANH THUC C s kinh doanh: Ngi ph trch : a im : Din tch: C s ring bit hay chung vi c s khc : M t s b iu kin c s: (nn, trn nh, v sinh mi trng..) *Nn Nha : nn ga#ch d v# sinh * Trn nh ; cao rao d v# sinh , u  anh sang * v sinh mi trng : thoang d v# sinh Trang thit b (T, quy, danh sch my mc, thit b, iu kin PCCC& .) Ti liu chuyn mn, vn bn php lut, quy ch dc, s sch theo di *Ti Liu : -Dc Th Quc Gia Vit Nam *Vn bn php lut : -Thng T 46/2011/TT-BYT , Ngy 21/12/2011 :Ban hnh nguyn tc , tiu chun  Thc Hnh tt Nh Thuc  . -Thng T 10/2013/TT-BYT , Ngy 29/03/2013 : Hng Dn chi tit thi hnh mt s iu v iu kin kinh Doanh Thuc. -Nghi nh 176/2013/N-CP ,Ngy 14/11/2013 :Qui nh s pht vi phm Hnh chnh trong l)nh vc y T Thng T 19/2014/TT-BYT : ban hanh ngay 02/06/2014 : Qui i#nh qua n ly thuc gy nghi#n ,thuc hng tm thn va tim cht dum lam thuc . -Qui nh ca B Y T 17/2005/Q-BYT ,Ngy 01/07/2005 v vic ban hnh Danh Mc thuc Thit Yu Vit Nam *Qui ch : -Quyt nh s 04/2008/Q-BYT ,Ngy 01/02/2008 :Ban hnh Qui ch k n v bn thuc theo n *S sch: 1.S cng tc vi c s Y T 2.S theo di hng ch s l 3.S theo di n thuc khng hp l 4.S theo di tc dng ph khng mong mun ca thuc 5.S theo di thng tin bnh nhn 6.S theo di thng bo thu hi thuc ,thuc km phm cht 7.S kim sot cht lng thuc t xut *S  i#a i m:  ................,ngy thng nm 20... Ch c s (K ghi r h tn) S  B TR MT BNG  SHAPE \* MERGEFORMAT  C a v quy thuc Ti xin cam oan v chu trch nhim v nhng li & & & & , ngy thng nm 20.... Ch c s hnh ngh (k, h tn) DANH MU#C KI M TRA  TH#C HANH TT NHATHUC ( Ban Hanh kem theo thong t 46/2011/TT-BYT ngay 21 thang 12 nam 2011 cua bo Y Te ) STTNI DUNG1Tn c s : a ch : S in thoi : 2Tn ch c s/ngi qun l hot ng chuyn mn: Giy chng nhn y  iu kin kinh doanhThuoc : 3Loi hnh ang ky kinh doanh : Quay Thuoc Ban Le Cho Doanh Nghiep - Ho Ca The - a iem ban le cua doanh nghiep: - a iem ban le cua c s KCB:  TTNOI DUNGTham chieuiem chuaniem congiem triem atGhi chu12345678INHAN S (19 iem)1.1Ngi quan ly chuyen mon1.1.1Co mat khi c s ban le hoat ong hoac thc hien uy quyen theo quy nhIII.4b2iem khong chap thuan21.1.2Co trc tiep tham gia ban thuoc ke nIII.4b22Kiem tra(1) SOP xem DS cokiem soat hoat ong nay khong (2) kiem tra thc te1.1.3Co tham gia kiem soat chat lng thuoc khi nhap ve va trong qua trnh bao quan tai ai ly thuocIII.4b11Kiem tra SOP vaphong van ve vai tro cua DS trong viec kiem soat chat lng1.1.4Co thng xuyen cap nhat kien thc chuyen mon (tham gia cac lp tap huan, boi dng chuyen mon)III.4b22Phong van1.1.5Co ao tao, hng dan nhan vien quy che, kien thc chuyen monIII.4b2(phong van,nhan vien, k.tra ho s ao tao nhan vien)1.1.6Co hng dan nhan vien theo doi tac dung khong mong muon va bao cao vi c quan y teIII.4b11.1.7Co cong tac vi y te c sIII.4b0.50.51.2Ngi ban le1.2.1Co u nhan vien phuc vu cho hoat ong cua ai ly thuoc? * So lng nhan vien: - Dc sy ai hoc: - Dc sy trung hoc:01 - Dc Ta: Cac bang cap khac:I.211C s co t 2 DSH tr len2Khong co1.2.2Bang cap chuyen mon phu hp vi cong viec c giaoI.1.311Hoi e anh giaCac nhan vien co u sc khoe e am ng cong viec, khong co nhan vien nao ang mac benh truyen nhiem0.50.5Quan sat thc te1.2.3Co mac ao Blu va eo bien hieu ghi ro chc danhIII.4a111.2.4 - Co c tham gia ao tao, cap nhat kien thc chuyen mon va phap luat y teIII.4a22(Kiem tra s hieu biet cua nhan vien)Tat ca nhan vien c huan luyen e hieu ro va thc hien ung cac nguyen tac GPP212Kiem tra s hieu biet cua nhan vien. Tr iem neu khong nam c1.2.5 - Co thai o hoa nha, lch s khi tiep xuc vi khach hangIII.4a0.50.51.2.6 -Gi b mat thong tin ve ngi benh?III.4a0.50.5Co quy nh trong SOP hoac noi quyIIC S VAT CHAT: 15 iem2.1 * Xay dng va thiet ke: - a iem co nh, rieng biet? - Khu trng bay bao quan rieng biet am bao kiem soat c moi trng bao quan thuocII.1212Nha thuoc co moi trng rieng biet hoan toan0.50.5co vach ngan kn va loi i riengBo tr ni cao rao, thoang mat, an toan, cach xa nguon o nhiem0.50.5Tran nha co chong bui0.50.5Tng va nen nha phang, nhan, de ve sinh, lau ra0.50.52.2* Dien tch va bo tr: Tong dien tch c s:II.2aDien tch phu hp vi quy mo kinh doanh 112.3Khu trng bay bao quan toi thieu 10m2II2a2iem khong chap thuan2Neu dien tch t 10m2 tr xuong th cham iem khong chap thuan2.4Khu trng bay bao quan 20m2 - 29m21Khu trng bay bao quan 30m2 tr len22.5Co khu vc e ngi mua thuoc tiep xuc va trao oi thong tinII.2a12.6Co voi nc ra tay cho nhan vien nha thuoc va ngi mua (Neu khuat co bien ch dan) II.2b, 2d0.5Khong yeu cau phai bo tr ca ra vao2.7 * Cac hoat ong khac: - Neu co pha che theo n th phai co phong rieng e pha che, co ni ra dung cu pha cheII.2b2iem khong chap thuanKhong pha che theo nCo khu vc rieng e ra le0.50.5 Co the xem xet chap thuan neu bo tr phong rieng hoac hop/ ngan rieng ra le thuoc  Khu vc ra le cach ly vi khu vc bao quan trng bay 0.5 Neu co kho bao quan th kho at yeu cau bao quan thuoc2iem khong chap thuanCo khu vc t van (khu vc t van am bao c tnh rieng t)11Co khu vc phong t van rieng (Trong khuan vien nha thuoc va thuan tien cho khach)0.52.8My pham, thc pham chc nang, dung cu y te co e khu vc rieng, khong anh hng en thuoc?II.2c11IIITRANG THIET B: 15 iem3.1Thiet b bao quan thuoc3.1.1Thiet b bao quan thuoc:II.3a 3b - Co u tu quay bao quan thuoc - Tu, quay, gia ke de ve sinh, bao am tham my11 Co nhiet ke, am ke(co hoi chuan va co ghi chep theo doi)11Ni ban thuoc u anh sang e am bao cac thao tac dien ra thuan li va khong nham lan11 Anh sang mat tri khong chieu trc tiep vao ni trng bay1.51.53.1.2* C s co thiet b bao quan e ap ng yeu cau bao quan ghi tren nhan:II.3a, 3b2iem khong chap thuan2VD: thuoc yeu cau bao quan mat hoac lanh, phai co tu lanh hoac hop bao quan chuyen dungNi ban thuoc co c duy tr nhiet o di 30oC, o am bang hoac di 75% va thoa man ieu kien bao quan cua thuoc2iem khong chap thuan2S dung thiet b kiem soat nhiet o, o am (may ieu hoa, quat, may hut am)3.2Dung cu bao b ra le va pha che theo n3.2.1Co bao b ra le thuoc?II.3c113.2.2Co bao b kn kh cho thuoc khong con bao b tiep xuc trc tiep II.3c113.2.3Thuoc dung ngoai va thuoc quan ly ac biet co c e trong bao b de phan bietII.3c113.2.4Thuoc ban le co ng trong bao b mang ten thuoc khac hoac cha noi dung quang cao cua mot thuoc khacII.3c113.2.5Thuoc pha che theo n ng trong bao b dc dungII.3c13.2.6Dung cu ra le va pha che theo n co phu hp va de lau ra, lam ve sinh?II.313.2.7Co thiet b tiet trung cac dung cu pha che theo n?II3.1IVGHI NHAN THUOC: 2 iem4.1* Thuoc ban le khong ng trong bao b ngoai cua thuoc c nh kem theo cac thong tin sau: - Ten thuoc, dang bao che - Nong o, ham lng Neu can (VD: khong co hoa n thuoc, khong co t HDSD neu ban so lng qua t)II.3d114.2* Thuoc pha che theo n, ngoai quy nh nh phan 4.1, co cac thong tin sau: - Ngay pha che? - Ngay het han s dung? -Ten benh nhan -Ten, a ch ni pha che? -Canh bao an toan cho tre em(neu co)?II.3d1VHO S SO SACH VA TAI LIEU CHUYEN MON: 17 iem5.1Ho s phap ly:5.1.1Cac giay t phap ly nh KKD, chng chu hanh nghe cua DS phu trach chuyen mon, GCNKKDT (oi vi c s ang hoat ong)I.12iem khong chap thuan25.1.2Co ho s nhan vien. (Ho s gom: HL, GCN sc khoe, bang cap chuyen mon, s yeu ly lch, cac chng ch ao tao)I.3115.2Tai lieu hng dan s dung thuoc:5.2.1Co tai lieu hng dan s dung thuocII.4a115.2.2Co cac quy che chuyen mon dc hien hanhII.4a115.2.3Co Internet e tra cu thong tin15.3Ho s so sach lien quan en hoat ong kinh doanh thuoc:5.3.1*Theo doi so lo, han dung thuoc va cac van e co lien quan: - Theo doi bang may tnh - Theo doi bang so - Theo doi viec pha che theo n ( neu co). Co so pha che - Ho s so sach co the tra cu kp thi khi can thiet. II.4b111Lu gi ho s so sach t nhat 1 nam ke t khi thuoc het han dung115.3.2*Co theo doi d lieu lien quan en benh nhan khong, v du n thuoc hoac benh nhan can lu y : -Theo doi bang may tnh -Theo doi bang so II.4b11 Ho s, so sach co the tra cu kp thi khi can thiet115.4Xay dng va thc hien cac quy trnh thao tac chuan:5.4.2* Co u cac quy trnh c ban theo yeu cau (noi dung quy trnh ung va phu hp vi hoat ong cua nha thuoc):II.4cQuy trnh mua thuoc va kiem soat chat lng11Quy trnh ban thuoc theo n11Quy trnh ban thuoc khong theo n11Quy trnh bao quan va theo doi chat lng11Quy trnh giai quyet vi thuoc b khieu nai hoac thu hoi115.4.3Co cac quy trnh khac (ghi cu the)II.4.c5.4.4Cac quy trnh thao tac chuan cua c s do ngi co tham quyen phe duyet va ky ban hanhPhu luc 2115.4.5Nhan vien ban thuoc ap dung thc hien ay u cac quy trnhII.4.c22Kiem tra kien thc va cac thao tac thc hien quy trnhVINGUON THUOC (3 iem)6.1*Co ho s cac nha cung ng thuoc co uy tn gom: -Ban sao GCN co u ieu kien kinh doanh thuoc -Co danh muc cac mat hang cung ng ?III.1.a11Co lu hoa n mua hang hp le11Tat ca thuoc tai nha thuoc c phep lu hanh hp phap (co SK, hoac so giay phep nhap khau)2iem khong chap thuan26.2Nha thuoc co ay u cac loai thuoc dung cho tuyen C trong danh muc thuoc thiet yeu Viet NamIII.1.0.50.5Kiem tra sat xuat mot so thuoc trong danh mucVIIThc hanh cac quy che chuyen mon -Thc hanh nghe nghiep: 18 iem7.1Quan ly thuoc gay nghien, thuoc hng tam than va tien chat theo quy nhIII.4.a117.2*Mua ban thuoc gay nghien, thuoc hng tam than ung quy cheIII.4a117.3Kiem tra, oi chieu so lng thuoc GN, thuoc HTT, tien chat tren so sach va thc te khpIII.4a127.4Nhan vien nha thc nam quy che ke n va biet cach tra cu danh muc thuoc ke nIII.4a1117.5Khi ban thuoc, ngi ban le co hoi ngi mua cac thong tin ve trieu chng benh, ve tnh trang ngi dung thuoc e tranh rui ro khi dung thuoc?III.2a11Trong SOP, theo doi hoat ong thc te, hoi nhan vien7.6Ngi co trnh o chuyen mon phu hp e ban cac thuoc ke trong n thuoc III.2c11Co kiem tra n trc khi ban11Nha thuoc co bien phap theo doi viec ban thuoc ke n1Neu n thuoc khong hp le, ngi ban thuoc co: - Hoi lai ngi ke n - Thong bao cho ngi mua - T choi ban11Co so theo doiCh Dc sy ai hoc c thay the thuoc trong n thuoc117.7* Khi ban thuoc, ngi ban le co t van va thong bao cho ngi mua: -La chon thuoc phu hp vi nhu cau ieu tr va kha nang tai chnh -Cach dung thuoc -Cac thong tin ve thuoc, tac dung phu, tng tac thuoc, cac canh bIII.2117.8Hng dan s dung thuoc co va noi bang li, va ghi nhan III.2a117.9*Khi giao thuoc cho ngi mua, ngi ban le thuoc co kiem tra oi chieu cac thong tin sau: - Nhan thuoc - Chat lng thuoc bang cam quan - Chung loai thuoc - So lngIII.2a117.1O - Ngi ban le, c s ban le khong tien hanh cac hoat ong thong tin, quang cao thuoc trai vi quy nh ve thong tin, quang cao III.2b11Kiem tra cac t ri quang cao, viec dan quang cao - Ngi ban le thuoc khong khuyen khch ngi mua thuoc nhieu hn can thiet 117.11Thuoc co u nhanIII.1c117.12Nhan thuoc va thuoc ben trong ung va khp vi nhauIII.1.c117.13* Sap xep thuoc: - Sap xep gon gang, de lay, tranh nham lan - Sap xep theo ieu kien bao quan ghi tren nhan - Co khu vc rieng cho"thuoc ke n"III.3117.14Thc hien niem yet gia thuoc ung quy nh va ban khong cao hn gia niem yetIII.4b11VIIIKIEM TRA/ AM BAO CHAT LNG THUOC: 5 iem8.1Co kiem tra, kiem soat khi nhap thuoc: - Han dung cua thuoc -Thuoc con nguyen ven trong bao b goc cua nha san xuat -Cac thong tin tren nhan thuoc (theo yeu cau quy che nhan), kiem soat chat lng bang cam quanIII.1c va III.1d211Kiem tra SOP va kiem tra thc teCo tien hanh kiem soat chat lng nh ky va ot xuat111Kiem tra so KSCL thuoc8.2F~      𮦞~qeVeJVe>h6CJaJmH sH hLCJaJmH sH hkhLCJaJmH sH hKCJaJmH sH hkhLaJmH sH (hhL56CJ \]aJmH sH hR{hUTCJ$aJ$hECJ$aJ$hmCJ$aJ$$hkhL56\]aJmHsHhkhL6]aJmHsHhkhL>*aJmHsH!hkhL5>*\aJmHsHhkhL5\aJmHsHF~   " B xgdlxgdNxgdNl$ 9!dD<a$gdL ]<gdL $xa$gdUT$ ]<a$gdL$ ]<a$gdL$ ]<a$gdd   " $ 2 < > @ B x | ~ $ & > N b ĸn]ċQAQh\3h\35CJaJmHsHh\3CJaJmHsH h s(hL5B*CJaJph h s(h 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