/^^il 8017 BOYTE TRU^OTNG DAI HOC Y HA NOI > BAO CAO KET QUA NGHIEN ClTU DE TAI NCKH CAP BO DANH GIA CHAT LlTONG NHtTNG XET NGHIEM HOA SINH MAU TAI CAC PHONG XET NGHIEM • • CUA CAC TUYEN Y TE CHU NHIEM DE TAI: PGS.TS PHAM THIEN NGOC CO QUAN CHU TRJ DE TAI: TRUTCiNG DAI HOC Y H A N Q I CO QUAN CHU Q U A N : B Q Y TE THC)I GIAN THl/C HIEN: tir thang nam 2006 din thang nam 2009 (QUYET DINH PHE DUYET SO 2788/QD-BYT NGAY THANG NAM 2006) HA NOI, - 2010 BOYTE TRlTONG DAI HOC Y HA NOI • • • BAO CAO KET QUA NGHIEN ClTU DE TAI NCKH CAP BO DANH GIA C H A T LU^QfNG NHlTNG XET NGHIEM HOA SINH MAU TAI CAC PHONG XET NGHIEM CUA CAC TUYEN Y TE CHU NHIEM DE TAI: PGS.TS PHAM THIEN NGOC CO QUAN CHU TRI DE TAI: TRUCiNG DAI HOC Y H A NQI CO QUAN CHU QUAN: B Q Y TE T H I GIAN THI/C HIEN: tir thang nam 2006 din thang ndm 2009 (QUYET DINH PRE DUYET SO 2788/QD-BYT NGAY THANG NAM 2006) Tdng kinh phi thirc hien de tai 351,0 trieu ddng Trong do: kinh phi SNKH 351,0 trieu ddng HA NOI, I - 2010 DANH SACH TAC GIA CUA DE TAI KH&CN CAP BO Ten detai: Bdnh gid chdt Iwang nhicng xet nghiim hod sinh mdu tgi cdc phong xet nghiim cua cdc tuyen y te Chu nhiem dl tai: PGS TS Pham Thien Ngoc Co quan chu tri de tai: Tm'dng Dai hoc Y Ha Noi Co quan quan ly dl tai: Bd Y tl Thu ky dl tai: CN Trdn Diic Tranh Danh sach nhirng ngudi thirc hien chinh: TT Chitky Hoc ham, hoc vi, ho va ten fl BSCK2 Tran Hoai Nam TS TranThiChiMai {JLm^-fM^ ^ CN Tran Diic Tranh PGS TS Nguyen Thi Ha DS CK2 Nguyen Thi Huong Ths Nguyen Chinh NghTa _ ;f^^^ -A^ Ths Hoang Thu Ha _ Cac tmdng khoa Hda sinh Benh Vien Tinh tham gia vao de tai Itt^/ QA^V^^ — O\Ht^' HIEU TRU'CWG TRUig^G DAI HOC Y HA NCU ^^Pes:TS Nguyi Lai cdm an Hoan de tai nghien ciru nay, thay mat nhdm nghien cuu, tdi xin bay td ldi cam an chan tai: Vu khoa hoc & Dao tao Bd Y te, ca quan da phe duyet, cap kinh phi va hd trg moi mat cho de tai thuc hien va nghiem thu Truang Dai hoc Y Ha Noi ca quan chu tri de tai va dac biet la phong nghien cuu khoa hgc, phdng tai chinh ke toan da giup dd tao moi dieu kien thuan lgi de de tai cd the thuc hien dugc theo ke hoach Can bd sd y te, va toan the can bo phdng xet nghiem benh vien Tinh, huyen, y te tu nhan, ddc biet cac trudng phdng xet nghiem benh vien tinh ma de tai da chon de thuc hien nghien cim da nhiet tinh, het long giiip dd, thuc hien cac xet nghiem va tao mgi dieu kien thuan lgi cho nhdm can bg dieu tra thu thap sd lieu, tai cac phdng xet nghiem thudc tinh Hd Noi, thdng 11 ndm 2009 Chu nhiem de tai Pham Thien Ngoc NHONG CHU'VIET TAT ALT Alanin Transferase AST Aspactat Transferase BS Bac sy CLXN Chit lugng xet nghiem DBCL Dam bao chat lifgng CT Cholesterol toan phan TG Triglycerid HDL-C Might density Lipoprotein- Cholesterol LDL-C Low density Lipoprotein- Cholesterol QA Quality Assurance ( Bao dam chat lu'gng) QC Quality Control ( Kiem tra chat lu'gng ) KTCL Kiem tra chat lurgng KTCLXN Kiem tra chat lurgng xet nghiem HSLS Hoa sinh lam sang HSM Hoa sinh mau NKT Noi kiem tra NgKT Ngoai kiem tra XN Xet nghiem XNHSLS Xet nghiem hoa sinh lam sang ISO International organization for standardization (To chLPC tieu chuan hoa quoc te ) PXN Phong xet nghiem KTV Ky thuat vien MDQ Mat quang MUC LUC o • Ddt van de Chuang 1: Tong quan 1.1 Khdi qudt chung ve chat lugng (Quality), he thong qudn ly chdt hrong qudc ti 1.2 Khdi niem ve ddm bdo citat luang vd kiem tra chdt Iwgng 1.2.1 Dam bao chat lugng 1.2.2 Kiem tra chat lugng 1.3 Cdc giai dogn cda chwang trinh DBCL 1.3.1 Giai doan trudc xet nghiem 1.3.2 Giai doan xet nghiem 1.3.3 Sir dung xet nghiem 1.4 Nhiing thong so thong ke sd dung viic KTCL 11 1.4.1 Dudng cong Gauss 11 1.4.2 Tri sd trung binh 12 1.4.3 Phuang sai 13 1.4.4 Do lech chudn 13 1.4.5 He sd phan tan 13 1.5 Kiim tra chdt lirang phong xet nghiim 13 1.5.1 Kiem tra chinh xac 14 1.5.2 Kiem tra xac thuc 19 1.6 Ngogi kiim tra chdt lirang 24 1.7 Cdc ky thugt hoa sinh diing de xdc dinh ndng Glucose, 25 Cholesterol, Canxi, Bilirubin todn phdn, Ure, Axit Uric vd hogt ALT, CK huyit r 1.7.1 Ky thuat dinh lugng Glucose huyet 26 1.7.2 Ky thuat dinh lugng Cholesterol toan phan huylt 27 1.7.3 Ky thuat dinhlugng Canxi huyet 27 1.7.4 Dinh lugng Bilirubin toan phan huyet 27 1.7.5 Dinh lugng Ure huyet 27 11 1.7.6 Xac dinh hoat ALT huyet (GIT) 27 1.7.7 Xac dinh hoat CK huyet 28 1.8 Nhung trang thiet bi hod sinh dexdc dinh nong •h) chdt hodc hogt 28 dp enzym dang dirac diing hien 1.8.1 May 29 1.8.2 Hoa chdt 29 1.9 Nhdn to ngiedi 29 Chuang 2: Doi tuong va phuang phap nghien ciiu 30 2.1 Doi tirang 30 2.2 Phuang phdp nghien cdu 30 2.2.1 Lira chon cac thdng sd hoa sinh mau de Idiao sat 30 2.2.2 Thiet ke nghien ciru dugc chia lam phan 31 Chuang 3: Ket qua nghien cuu 33 3.1 Mot so thong tin chung vi phong xet nghiem hod sinh 33 3.2 Kit qud lan XN cdc chi sd hod sinh huyit kiim tra 37 dmiec 3.2.1 Khu VU'C Miin Bdc vd Miin Trung 37 3.2.2 Khu virc Miin nam vd Ldm Dong 42 3.3 Kit qud 5lan XN cdc chi so hod sinh huyit kiim trad 47 mdc 3.3.1 Khu viec Mien Bdc vd Miin Trung 48 3.3.2 Khu vwc Miin nam vd Ldm Dong 53 3.4 Kit qud XN huyit kiim tra a muc so vdi khodng gid tri 57 thuc (dp xdc thuc) 3.4.1 Khu vuc Miin Bdc vd Miin Trung 57 3.4.2 Khu vuc Miin nam vd Ldm Dong 59 3.5 Kit qud XN huyit kiim tra d muc so v&i khodng gid tri 61 thuc (dp xdc thuc) 3.4.L Khu vuc Miin Bdc vd Mien Trung 61 3.4.2 Khu vuc Miin nam vd Ldm Dong 63 Chuang 4: Ban luan 66 4.1 Bdn ludn vi tinh hinh chung cdc phong xet nghiem 66 111 4.1.1.Trang thiet bi 66 4.1.2 Nhan luc ' 67 •? r 4.2 Kit qud kiem tra chdt luang xet nghiem hod sinh cua cdc phong 69 xet nghiem 4.2.1 Ket qua lan xet nghiem sd chi sd hoa sinh huyet 69 kiem tra mirc 4.2.2 Ket qua Slan xet nghiem sd chi sd hoa sinh huyet 74 kiem tra muc ' rr r 4.3 Kit qud xet nghiem huyit kiim tra muc vd muc cua cdc 11 chi sd xet nghiem doi chieu vai gid tri thuc cua hdng sdn xudt Ket luan 85 Kien nghi va de xuat giai phap 87 T A I LIEU THAM KHAO PHU LUC IV DANH MUC BANG Trang Bang 3.1 Thdng tin ve ca sd xet nghiem va nhan su khu vuc Mien Bac va Mien Trung 33 Bang 3.2 Thdng tin ve ca sd xet nghiem va nhan su khu vuc Phia Nam 34 Bang 3.3 Thdng tin ve trang bi may xet nghiem va KTCLXN 35 f r Bang 3.4 Mot sd loai may, Hda chat dang dugc su dung tai cac phdng xet nghiem 36 Bang 3.5 Cac ket qua lan xet nghiem cac chi sd ve Glucose, Cholesterol, Canxi, Bilirubin TP mirc Idiu vuc Mien Bac va Mien Trung 37 Bang 3.6 Cac ket qua lan xet nghiem cac chi sd Ure, ALT, CK, mirc khu vuc Mien Bdc vaMien Trung 40 Bang 3.7 Cac ket qua lan xet nghiem cac chi sd ve Glucose, Cholesterol, Canxi, Bilirubin TP muc khu vuc Mien Nam va Lam Ddng r \ 42 r Bang 3.8 Cac ket qua lan xet nghiem cac chi sd Ure, ALT, CK, mirc khu vuc Mien Bdc va Mien Trung 45 Bang 3.9 Ket qua xet nghiem Glucose, Cholesterol, Canxi, Bilirubin muc khu vuc Mien Bac va MienTrung r 48 r 'x Bang 3.10 Cac ket qua lan xet nghiem cac chi sd Ure, ALT, CK, mirc khu vuc Mien Bdc va Mien Trung SO Bang 3.11 Ket qua xet nghiem Glucose, Cholesterol, Canxi, Bilirubin muc khu vuc Mien Nam va Lam Ddng f \ 53 r Bang 3.12 Cac ket qua lan xet nghiem cac chi sd Ure, ALT, CK, mirc khu vuc Mien Bac va Mien Trung 55 r Bang 3.13 Ket qua xet nghiem Glucose, Cholesterol, Canxi, Bilirubin TP muc khu vuc Mien Bac va Mien Trung(so vdi gia tri thuc) 57 MAUPHIEU Biiu TRA BO Y TE CONG HOA XA HOI CHU NGHIA VIET NAM SdYte Ddc lap - Tu Hanh phiic PHIEU THU THAP THONG TIN PHONG XN HOA SINH THUOC Bi TAI HOA SINH- BO Y TE Ten benh vien Tuyen benh vien : Tinh • Hinh thuc quan Iy benh vien : Huyen (thi xa) • Nha nude.D Tu nhan.P Da khoa: D Chuyen khoa P Loai benh vien: Loai I • Loai II D Loai III • Sd giudng benh 1000 giudng.D 500 -1000 giudng .P 3- NJ I CO CO "ov I CO CO _pv "oo ft c c — Ji vO CO oo I O -J OS U C/i Ji — o vo -J CO CO Ji o c^ Ov I Ul I o OS CO oo o 3 o •^ o -o CO 00 so o Ul cyi cyi "*> ".^ "ON "NJ Ul so "Ji NJ "so "c/i "U) to NJ "os o I CO to CO so CO NJ c^ "NJ 00 ^00 "o "o CO 00 CO c/l NJ to NJ to 00 "ov oo NJ — -J -J Ov OS OS Ul I 00 NJ "j^ SO CO t- JsJ "oo Jjj CO 00 to JO "-J "to CO I "Ji Ul so 00 -J "NJ "O O "o 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