Vlkomna !

En regionaliserad myndighet

Rttsenheten

Generaldirektr

Avdelning nord

UME Avdelning mitt

REBRO Avdelning st

STOCKHOLM

Avdelning sydst

JNKPING

Avdelning sydvst

GTEBORG

Avdelning syd

MALM

Avdelningen fr verksamhetsstd och styrning

Generaldirektrens

stab

Avdelningen fr analys och utveckling

Internrevision Insynsrd

Avdelningen fr Tillstndsprvning

STOCKHOLM

*Nationell samordning av Blod- vvnad/cell och organ hantering

Analys- Tillsynsterfring- Vgledning

IVO ska regelbundet analysera och dra generella slutsatser av de brister och missfrhllanden som myndigheten ser i verksamheterna inom hlso- och sjukvrd och socialtjnst

IVO ska terfra brett vad myndigheten ser i tillsynen fr ett systematiskt lrande och fr att undvika att brister och missfrhllanden upprepas

IVO ska inom ramen fr sin tillsyn lmna rd och ge

vgledning till verksamheterna i vrd och omsorg

- Programpunkter 9-12

Informationsverfring (2012/25/EU) delegerade inrttningar

SOSFS 2015:6

Samverkan SoS-IVO

Senaste nytt donationsutredningen

Avvikelser / biverkningar

rsrapporter

Inspektioner

Direktiv 2012/25/EU

Informationsverfring mellan medlemsstater nr organ verfrs mellan medlemstater.

Frordning 2012:346 (2014:831)

SOSFS 2015:6

Direktiv 2012/25/EU

IVO s skyldigheter enligt direktivet:

Utse de svenska delegerade inrttningarna = vrdgivarna som ansvarar fr transplantation

Upprtthlla register ver kontaktuppgifter

till myndighet och delegerade inrttningar

http://txcontactlist.eu/

Mottagare av anmlningar av avvikande hndelser / biverkningar

http:http://txcontactlist.eu

Delegerade inrttningars skyldigheter enligt direktivet:

Vidarebefordra/ mottaga uppgifter om organet (24/7)

Vidarebefordra/ mottaga uppgifter om avvikande hndelser och biverkningar (24/7)

Anmla avvikande hndelser / biverkningar till IVO

SOSFS 2015:6

Samverkan mellan SoS och IVO

Donationsutredningen ?

Samverkan IVO-SoS avseende rapporter till EU

Transposition av Direktiv Vilken svensk lag/ freskrift motsvarar /.

Implementering av Direktiv (nyheter) Hur fljer SE (verksamheterna) Direktivet Frivillig obetald donation (opt-in /opt-out)

rsrapporten (hur mnga rapporterar)

Hur mnga inspektioner grs

Hur mnga organ exporteras / importeras

Olika EU-projekt som ska kartlgga hur det ser ut

E""!'ean Convnission

Main sections in the survey... and in the final report:

A - Identification of Competent authorities and overall set-up

(i ncl ud ing Articles 17: tasks, 21: EOEOs, and reg iona I leve I)

B - Organ procurement, donor and recipient protection (art. 5, 6, 7,

12, 14) including authorisation of procurement centres, organ and donor ch ara cterisation, consent, person nel etc.

C - Transport (art. 8)

D - Organ transplantation (art. 9, 12) including authorisation of

tra nsplant cent res, person n el etc.

E - Framework for quality and safety (art. 4, 17) including

control/a ud its, issu e of guida n ce to h ea lthca re esta blish ments etc.

F - General comments

4

Number of CAs declared at national level (corrected - but still to be confirmed via fo llow-up

15 questions)

1 5 ~-------

12 +----t-1'1----

9 +--

6 +--3

3 +--

0 -+---1 CA: 2 C/ls: 3 C/ls: 4 CAs:

BE, BG, CY, DE, DK, AT, CZ, EL, FI, FR, LV, NL, HU LT EE, ES, HR, LU, NO IE, IT, MT, PL, PT,

RO, SE, SI, SK, UK

Does the authorisation of procurement organisations: lnclude authorisation for all

type ofdonors (DBD, DCD, LD)?

Tvoe No. of

counlries Counlries

YES 14 AT, BE, CY, CZ, ES, FI, IE, rr, LV, MT, PT, s1, SK, UK

NO 9 BG, DE, EL, HU, HR, LU, PL, NO, RO

NIA 6 OK. EE. FR. LT. NL. SE

E..-opean

Convnission 7 Original answers,

not yet corrected I double-checked (also

with answers to other questions)

Does the authorisation of procurement organisations include authorisation to retrieve all organs from a donor?

...: ~:~ ~:~ : : ~ ~~ ~:~ : : ~ ~~ ~:~ : :~ ~~ ,.

w~:::: ~~~~

YES: AT, BE, ev, cz, DE, ES,

FI, HR, IT, LU, LV, MT,

PT, NO, RO, SI, SK, UK;

18

BG, H~~;E, PL; /~l~1:!~j~]~j4

Does the authorisation of POs include authorisation for all type of donors (DBD, DCD, LD)? 7 YES in 14/29 MS

Does the authorisation of procurement organisations include authorisation to retrieve all organs from a donor? 7YES in 18/29 MS

7 It seems that general authorisations schemes are prefered for POs

E""Pean Commission

How do you make sure that the healthcare personnel involved in the donation and

procurementare suitably qualified or trained and competent?

20 20 ~Original answers, not yet

corrected I double-checked (also with answers to other questions)

10

7

3

AT, BG, CZ, DE, DK, EL, FR, HR, BG, CZ, DE, DK, EL, FR, HR, IE, IE, IT, LT, LU, LV, MT, NL, NO, IT, LT, LU, LV, MT, NL, NO, PL,

PL, SE, SI, SK PT, SE, SI, SK

BG, CZ, DE, EL, HR, IE, IT, NO, PL, SI

CY, FI, FR, LV, PT, RO, UK BE, EE,ES

At the moment of recruitment (qualifi cations)

Through regular training program mes

Through certifi cation other Countries that did not answer

The 2 main methods to make sure that healthcare personnel involved in procurement activities are suitably qualified or trained and competent are:

- At the moment of recruitment (20/29) - Through regular training program mes (20/29)

16

Elnpean Convnission

Number of Member States who declared to have operating procedures in place ('Are in your Member State operating procedures adopted and implemented for. .. ?')

30 26 26 2625 25

25

20

15

10

5

0 ~ ~~~~~~~~~~~~~~~~~~~ CZ, DE, DK, EE, CZ, DE, DK, EE, El , ES, FJ, FR, EL, ES, Fl, FR, HR, IT, LT, LU, H R, IT, LT, LU,

LV, MT, NL, NO, LV, MT , NL, NO, PL, SE, SI, SK, PL, SE, SI, SK,

UK UK

d( l) The d(2) The P

Working Group on lndicators

under the Action Plan on Organ donation and transplantation

2014 Exercise - CA meeting on 11-12 March 2014

1. Donation

2. Waiting lists

3. Allocation

4. Transplantation

5. Health outcomes

6. Health resources

5. HEALTH OUTCOMES - SELECTED INDICATORS

Definitions Data-Sourceslndicators

Need to know no. of EC survey (excel) Registries (per organ) patients monitored

(nominator) (31 countries replied for the 2014 exercise 1 year survival of but data only

Grafts partially available for health

Patients outcomes) Per organ

Samverkan IVO-SoS avseende sakfrgor (statistik,

freskrifter, information till /frn Soc-departementet).

IVO rapporterar vvnadsstatistik (avlidna donatorer) till livsviktigt. se

SoS informerar IVO om Nyheter i freskrifter

Aktuell / Ssongsberoende smittinfo

Utbyter minnesanteckningar frn CA mten

SoS och IVO har inloggning till RATC

I RAPID RISKASSESSMENT

Invasive ca nfiovascular: infection by Mycobacttrlum chlm1111r11 potential!)'. associated

with heater-cooler units used Cluring cardi!'lc surge!)'. 1~pdate \!Z,e.Rril 2015

Main conclusions and options for response Shce lJly 20:4, ten cases of hvasWe cardbvascular infection caused by Mycobactetir.Kn chin aera, hcl.Jdhg four fatal outcomes, have been detected n patients who had prevbustt undergone ccrdac surgery in Swi'2erL:ind, the Netherlands and Gernany. Aerosolsatbn of water from t~e heater-cooler unts for extracorporeal cf'cuL:ition in the operating room .......as

consi:lered the m ost pL:iusbe route of infectbn.

Heathcare prJviders involved in caring for patents vJ-io have undergone open-heart surgery shoukj be viaiant for cases of endocardtis or other cardbvascular infectbn of uni:lentifed ori;lin and consider testhg speciftcally for sb\o'rgrowhg non-tubercl.bus m ycobacteria such as Mycobactetir.Kn chinaera. Regulatory bodies n charge of li:ensing and agencies m onitoring the safety of such devices should be aware of the potential associatbn of nvasive cardiJvascuL:ir Ofections caused by Mycobacteriln chinae.i-a with heater-cooer units reported by Sax et al. [ 1) and reevant inform atbn should be dissem inated to al centres perfom ing cardiac surgery,

ECDC is undetalQng further work to evalJate the publc heath inpa:t of invasWe cardiovascuL:i Ofectbn by Mycobactetir.Kn chin aera associated wth heater~ooler units, and wll publish an updated risk assessment as soon as this evaluatDn has been com pleted .

http:Mycobactetir.Knhttp:Mycobactetir.Knhttp:Mycobactetir.Kn

SOSFS 2015:6

Samverkan mellan SoS och IVO

Donationsutredningen

Rapportering av avvikande hndelser /

biverkningar

Definition av avvikande hndelse / biverkning

Nr till vem ska det rapporteras ? preliminr anmlan -IVO

slutlig anmlan -IVO

Vad ska rapporteras ?

kontaktuppgifter, donators-ID (Sct ID + SE)

lpnr p anmlan (del 1 del 2) ert Avvikelsenr

beskrivning av hndelsen / orsak

Vidtagna tgrder (initiala / fr att minska risken fr upprepning)

CONSEQUENCES OF RECURRENCE

IMPACT LEVEL INDIVIDUAL SY