Documente Academic
Documente Profesional
Documente Cultură
PARTEA B
Reacii adverse grave - niveluri de imputabilitate
Niveluri de imputabilitate pentru aprecierea reaciilor adverse.
______________________________________________________________________________
__
Nivelul de
| Explicaie
imputabilitate
|
________________________|_____________________________________________________
PARTEA C
Formular de confirmare a reaciilor adverse grave
_____________________________________________________________________
Unitatea raportoare
_____________________________________________________________________
Identificarea notificrii
_____________________________________________________________________
Data confirmrii (an/lun/zi)
_____________________________________________________________________
Data reaciei adverse grave (an/lun/zi)
_____________________________________________________________________
Confirmarea reaciei adverse grave (da/nu)
_____________________________________________________________________
Nivel de imputabilitate (NA, 0-3)
_____________________________________________________________________
Modificarea tipului de reacie advers grav (da/nu)
_____________________________________________________________________
Dac da, a se preciza
_____________________________________________________________________
Evoluia clinic (n cazul n care este cunoscut)
- recuperare complet
- sechele minore
- sechele grave
- deces
_____________________________________________________________________
PARTEA D
Formular de notificare anual a reaciilor adverse grave
______________________________________________________________________________
Unitatea raportoare
______________________________________________________________________________
Perioada de notificare
______________________________________________________________________________
Acest tabel se refer la:
| Numrul de uniti eliberate (numrul total
de
_______________________________| uniti eliberate cu un anumit numr de
[] Tot sngele
| componente sangvine)
_______________________________|______________________________________________
[] Eritrocite
| Numrul de recipieni transfuzai (numrul
_______________________________| total de recipieni transfuzai cu un anumit
[] Trombocite
| numr de componente sangvine) (n cazul n
care
_______________________________| este disponibil)
[] Plasm
|
_______________________________|
[] Altele
|
_______________________________|______________________________________________
(a se folosi tabele
| Numrul de uniti transfuzate [numrul total
separate pentru fiecare
| al componentelor sangvine (al unitilor)
component)
| transfuzate de-a lungul perioadei de
| notificare] (n cazul n care este
disponibil)
_______________________________|______________________________________________
| Numrul | Numrul reaciilor adverse grave
cu
| total
| un nivel de imputabilitate de la 0
| raportat | la 3 dup confirmare (a se vedea
_______________________________|__________| anexa IIA)
| Numrul |
| deceselor|
_______________________________|__________|___________________________________
|
| Nu se | Nivel| Nivel| Nivel| Nivel
|
| poate
______|______|______|________
|
| evalua| 0
|
1 |
2 |
3
_______________________________|__________|_______|______|______|______|______
__
Hemoliz
|Datorat
| Total
|
|
|
|
|
imunologic|incompatibilitii
__________|_______|______|______|______|________
| de tip ABO
| Decese
|
|
|
|
|
___________________|__________|_______|______|______|______|________
|Datorat unui alt | Total
|
|
|
|
|alloanticorp
__________|_______|______|______|______|________
|
| Decese
|
|
|
|
|
___________|___________________|__________|_______|______|______|______|______
__
Hemoliz nonimunologic
| Total
|
|
|
|
|
__________|_______|______|______|______|________
| Decese
|
|
|
|
|
_______________________________|__________|_______|______|______|______|______
Infecie bacterian transmis | Total
|
|
|
|
|
prin transfuzie
__________|_______|______|______|______|________
| Decese
|
|
|
|
|
_______________________________|__________|_______|______|______|______|______
Anafilaxie/hipersensibilitate | Total
|
|
|
|
|
__________|_______|______|______|______|________
| Decese
|
|
|
|
|
_______________________________|__________|_______|______|______|______|______
__
Insuficien respiratorie acut| Total
|
|
|
|
|
posttransfuzional
__________|_______|______|______|______|________
| Decese
|
|
|
|
|
_______________________________|__________|_______|______|______|______|______
__
Infecie viral|
HBV
| Total
|
|
|
|
|
transmis prin |
|__________|_______|______|______|______|________
transfuzie
|
| Decese
|
|
|
|
|
_______________|__________|_______|______|______|______|________
|
HCV
| Total
|
|
|
|
|
__________|_______|______|______|______|________
|
| Decese
|
|
|
|
_______________|__________|_______|______|______|______|________
|
HIV-1/2
| Total
|
|
|
|
|
__________|_______|______|______|______|________
|
| Decese
|
|
|
|
_______________|__________|_______|______|______|______|________
| Altele
| Total
|
|
|
|
|
| (a se
preciza)|__________|_______|______|______|______|________
|
| Decese
|
|
|
|
|
_______________|_______________|__________|_______|______|______|______|______
__
Infecie
| Malarie
| Total
|
|
|
|
|
parazitar
|
__________|_______|______|______|______|________
transmis prin |
| Decese
|
|
|
|
|
transfuzie
_______________|__________|_______|______|______|______|________
| Altele
| Total
|
|
|
|
|
| (a se
preciza)|__________|_______|______|______|______|________
|
| Decese
|
|
|
|
|
_______________|_______________|__________|_______|______|______|______|______
__
Purpur posttransfuzional
| Total
|
|
|
|
|
__________|_______|______|______|______|________
| Decese
|
|
|
|
|
_______________________________|__________|_______|______|______|______|______
__
Reacia grefei contra gazdei
| Total
|
|
|
|
|
__________|_______|______|______|______|________
| Decese
|
|
|
|
|
_______________________________|__________|_______|______|______|______|______
Alte reacii grave
| Total
|
|
|
|
|
(a se preciza)
|__________|_______|______|______|______|________
| Decese
|
|
|
|
|
_______________________________|__________|_______|______|______|______|______
ANEXA III
NOTIFICAREA INCIDENTELOR ADVERSE GRAVE
PARTEA A
Formular de notificare rapid a incidentelor adverse grave
______________________________________________________________________________
__
Unitatea raportoare
______________________________________________________________________________
__
Identificarea notificrii
______________________________________________________________________________
__
Data notificrii (an/lun/zi)
______________________________________________________________________________
__
Data apariiei incidentului advers grav (an/lun/zi)
______________________________________________________________________________
__
Incident advers grav care poate
| Precizri
afecta calitatea i securitatea
|__________________________________________
componentelor sangvine din cauza unei|Produs
|Echipament|Eroare|Altele
probleme privind:
|necorespunztor|defect
|uman |(a se
|
|
|
|preciza)
_____________________________________|_______________|__________|______|______
__
Recoltarea de snge total
|
|
|
|
_____________________________________|_______________|__________|______|______
__
Recoltarea prin aferez
|
|
|
|
_____________________________________|_______________|__________|______|______
__
Testarea donrilor
|
|
|
|
_____________________________________|_______________|__________|______|______
__
Prelucrarea
|
|
|
|
_____________________________________|_______________|__________|______|______
__
Stocarea
|
|
|
|
_____________________________________|_______________|__________|______|______
__
Distribuirea
|
|
|
|
_____________________________________|_______________|__________|______|______
__
Materialele
|
|
|
|
_____________________________________|_______________|__________|______|______
__
Altele (a se preciza)
|
|
|
|
_____________________________________|_______________|__________|______|______
__
PARTEA B
Formular de confirmare a incidentelor adverse grave
_____________________________________________________________________
Unitatea raportoare
_____________________________________________________________________
Identificarea notificrii
_____________________________________________________________________
Data confirmrii (an/lun/zi)
_____________________________________________________________________
Data apariiei incidentului advers grav (an/lun/zi)
_____________________________________________________________________
Analiza principalelor cauze (detalii)
_____________________________________________________________________
Msuri corective adoptate (detalii)
_____________________________________________________________________
PARTEA C
Formular de notificare anual a incidentelor adverse grave
______________________________________________________________________________
__
Unitatea raportoare
______________________________________________________________________________
__
Perioada de notificare
| 1 ianuarie - 31 decembrie (anul)
____________________________________|_________________________________________
__
Numrul total de uniti de snge i componente sangvine prelucrate:
______________________________________________________________________________
__
Incident advers grav care
| Numr| Precizri
poate afecta calitatea i
|
total|__________________________________________
securitatea componentelor
|
| Produs
|Echipament|Eroare|Altele
sangvine din cauza unei
|
| defectuos
|defect
|uman |(a se
probleme privind:
|
|
|
|
|preciza)
______________________________|______|_______________|__________|______|______
__
Recoltarea de snge total
|
|
|
|
|
______________________________|______|_______________|__________|______|______
__
Recoltarea prin aferez
|
|
|
|
|
______________________________|______|_______________|__________|______|______
__
Testarea donrilor
|
|
|
|
|
______________________________|______|_______________|__________|______|______
__
Prelucrarea
|
|
|
|
|
______________________________|______|_______________|__________|______|______
__
Stocarea
|
|
|
|
|
______________________________|______|_______________|__________|______|______
__
Distribuirea
|
|
|
|
|
______________________________|______|_______________|__________|______|______
__
Materialele
|
|
|
|
|
______________________________|______|_______________|__________|______|______
__
Altele (a se preciza)
|
|
|
|
|
______________________________|______|_______________|__________|______|______
__