Välkomna ! En regionaliserad myndighet
Insynsråd
Generaldirektör
Internrevision
Generaldirektörens
Avdelningen för verksamhetsstöd
och –styrning
stab
Rättsenheten
Avdelningen för
analys och
utveckling
Avdelning nord
Avdelning mitt
UMEÅ
ÖREBRO
Avdelning öst
STOCKHOLM
Avdelningen för
Tillståndsprövning
STOCKHOLM
*Nationell samordning av
Blod- vävnad/cell och
organ hantering
Avdelning sydöst
Avdelning sydväst
Avdelning syd
JÖNKÖPING
GÖTEBORG
MALMÖ
Analys- Tillsynsåterföring- Vägledning
IVO ska regelbundet analysera och dra generella slutsatser
av de brister och missförhållanden som myndigheten ser i
verksamheterna inom hälso- och sjukvård och socialtjänst
IVO ska återföra brett vad myndigheten ser i tillsynen för ett
systematiskt lärande och för att undvika att brister och
missförhållanden upprepas
IVO ska inom ramen för sin tillsyn lämna råd och ge vägledning till verksamheterna i vård och omsorg
- Programpunkter 9-12
Informationsöverföring (2012/25/EU) ”delegerade
inrättningar”
SOSFS 2015:6
Samverkan SoS-IVO
Senaste nytt donationsutredningen
Avvikelser / biverkningar
Årsrapporter
Inspektioner
Direktiv 2012/25/EU
• Informationsöverföring mellan
medlemsstater när organ överförs mellan
medlemstater.
–Förordning 2012:346 (2014:831)
–SOSFS 2015:6
Direktiv 2012/25/EU
IVO ´s skyldigheter enligt direktivet:
– Utse de svenska delegerade inrättningarna =
vårdgivarna som ansvarar för
transplantation
– Upprätthålla register över kontaktuppgifter till myndighet och delegerade inrättningar – http://txcontactlist.eu/
– Mottagare av anmälningar av avvikande
händelser / biverkningar
Delegerade inrättningars skyldigheter enligt direktivet: • Vidarebefordra/ mottaga uppgifter om organet (24/7)
• Vidarebefordra/ mottaga uppgifter om avvikande
händelser och biverkningar (24/7)
• Anmäla avvikande händelser / 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/ föreskrift motsvarar /.
• Implementering av Direktiv (nyheter)
– Hur följer SE (verksamheterna) Direktivet
•
•
•
•
Frivillig obetald donation (opt-in /opt-out)
Årsrapporten (hur många rapporterar)
Hur många inspektioner görs
Hur många organ exporteras / importeras
• Olika EU-projekt som ska kartlägga ”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 in g 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 nspla nt 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
15
Number of CAs declared at national level
(corrected - but still to be confirmed via fo llow-up
questions)
15
~-------
12 + - - - -t-1'1-- - -
9
6
+--
3
+--
0
-+---
+--
3
1 CA:
BE, BG, CY, DE, DK,
EE, ES, HR, LU, NO
2 C/ls:
AT, CZ, EL, FI, FR,
IE, IT, MT, PL, PT,
RO, SE, SI, SK, UK
3 C/ls:
LV, NL, HU
4 CAs:
LT
E..-opean Convnission Does the authorisation of procurement
organisations: lnclude authorisation for all
type of donors (DBD, DCD, LD)?
Tvoe
YES
No. of
counlries
14
NO
9
NIA
6
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?
Counlries
YES:
AT, BE, ev, cz, DE, ES, FI, HR, IT, LU, LV, MT, AT, BE, CY, CZ, ES, FI,
IE, rr, LV, MT, PT, s1,
SK, UK
BG, DE, EL, HU, HR, LU,
PL, NO, RO
··: ~:~~:~··:···
...
: ~~~~:~: : ~~~~:~: :~~~,.
BG,
PT, NO, RO, SI, SK, UK;
H~~;E, /~l~1:!~j~]~jw~: : ·
18
PL;
4
~~~~
OK. EE. FR. LT. NL. SE
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, BG, CZ, DE, EL, HR, IE, IT, NO,
IE, IT, LT, LU, LV, MT, NL, NO, IT, LT, LU, LV, MT, NL, NO, PL,
PL, SI
PL, SE, SI, SK
PT, SE, SI, SK
CY, FI, FR, LV, PT, RO, UK
BE, EE,ES
Through regular training
program mes
other
Countries t hat did not answer
At the moment of
re cruitment (qualifi cations)
Through certifi cation
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
Numbe r of Member States who declared to have operating procedures in place
('Are in your Member State operating procedures adopted and implemented for. .. ?')
30
25
25
26
25
26
26
25
25
25
20
15
10
5
0
~ ~ ~~~~~~~ ~~ ~~~~~~~~~
~ ~~~~~~~
CZ, DE, DK, EE, CZ, DE, D K, EE, CZ, DE, DK, EE, CZ, DE, DK, EE, CZ, DE, D K, EE,
DE, DK, EE, EL, D E, DK, EE, EL,
El , ES, FJ, FR,
EL, ES, Fl, FR,
El, ES, FJ, FR,
EL, ES, Fl, FR,
ES, FJ, FR, HR,
El, ES, Fl, FR,
ES, FJ, FR, HR,
HR, IT, LT, LU, H R, IT, LT, LU, HR,. HU, IT, LT, H R, H U, IT, LT, HR, H U, IT, LT,
HU, IT, LT, LU, H U, IT, LT, LU,
LV, MT, NL, NO, LV, MT , NL, NO, LU, LV, MT, N L, LU, LV, MT, NL, LU, LV, MT , NL, LV, MT, NL, NO, LV, MT, NL, NO, LV, MT , NL, NO,
PL, SE, SI, SK,
PL, SE, SI, SK,
UK
UK
NO, PL, SE, SI, NO, PL, SE, SI,
SK, UK
d( l) The
d(2) The
d(3) The
P<Ocurement of l)<eservat lon of
OfQ?ln!=:; in
OfQ(')n~ in
packaging of
OrQ?lfl$;. in
r
SK, UK
d(4) The labelllng of OfQ?ln~ in NO, PL, SE, SI,
UK e) The
F) EnsurinJ transportatlon of traceability, in
OrQ?lll.C:: In
accordance w ith accorda nce with acoo rdance w ith accordance w ith accordance with
Artld es 5, 6 and Artldes 5, 6 and Artid es 5, 6 and
8
8
8
tldes 5, 6 and
PL, SE, SI, SK,
SK, UK
Artld e 8
8
;,c;m rt1;,n~ w ith
PL, SE, SI, SK,
PL, SE, SI, SK,
UK
UK
g ) The
h) The
accurate, rapid management of
?ln<1 VP.rif i?thlP.
~P.f iOll~ ?l<IVP.f!=:;P.
Artide 10,
reporäng of
events and
guarant eelng
serlous adverse
reactlons In
compliance with
the un ion and
advents and
reac:äons in
acco rdance w ith
Article 11(2) .
national
accorda nce w lth
provis ions :>n
the protection
Artide 1 1( 1).
on personal data
and
conf identla lity
Missing countries
dl1l
dl2l
dl3l
dl4l
e
f
0
h
HU,IE. RO, PT
HU, IE. RO, PT
IE,RO, PT
IE,RO, PT
IE. RO, PT
AT, IE. RC, PT
AT, IE. RO, PT
AT,IE. RO,PT
28
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 lndicators
•
•
Registries (per organ)
1 year survival of
• Grafts
•
Patients
•
Per organ
Definitions Data-Sources
•
•
Need to know no. of patients monitored
(nominator) EC survey (excel)
(31 countries
replied for the
2014 exercise
but data only
partially available
for health
outcomes)
Samverkan IVO-SoS avseende sakfrågor (statistik, föreskrifter, information till /från Soc-departementet). • IVO rapporterar vävnadsstatistik (avlidna
donatorer) till livsviktigt. se
• SoS informerar IVO om
– Nyheter i föreskrifter
– Aktuell / Säsongsberoende smittinfo
• Utbyter minnesanteckningar från CA –möten
• SoS och IVO har inloggning till RATC
RAPID RISKASSESSMENT
I
•
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 most 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 unde·talQng 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 .
• SOSFS 2015:6
• Samverkan mellan SoS och IVO • Donationsutredningen
Rapportering av avvikande händelser / biverkningar  Definition av avvikande händelse / biverkning
När – till vem ska det rapporteras ?
preliminär anmälan -IVO
slutlig anmälan -IVO
Vad ska rapporteras ?
kontaktuppgifter, donators-ID (Sct –ID + SE)
löpnr på anmälan (del 1 –del 2) ert Avvikelsenr
beskrivning av händelsen / orsak
Vidtagna åtgärder (initiala / för att minska risken för
upprepning)
CONSEQUENCES OF RECURRENCE
IMPACT LEVEL
0
Insignificant
1
Minor
2
Moderate
3
Major
4
Catastrophic
/Extreme
INDIVIDUAL
SYSTEM
OTC SUPPLY
Nil
No effect
Insignificant
Non serious
Minor damage
Some applications
postponed
Serious
Damage for short
period
Many cancellations or
postponements
Life
threatening
Major damage to
system –significant
delay to repair
Significant
cancellations
Death
System destroyed
need to rebuild
All allogenic
applications cancelled
Risk-Matris: Vad ska anmälas till IVO och vad
ska anmälan leda till ?
Likelihood of
recurrence
Consequences of
recurrence
Rare
1
Unlikely
2
Possible
3
Likely
4
Probable
5
Insignificant
0
0
0
0
0
0
Minor
1
1
2
3
4
5
Moderate
2
2
4
6
8
10
Major
3
3
6
9
12
15
Catastrophic
4
4
8
12
16
20
Rapporterade avvikelser (biverkning) 3
2
*
*
1
2012
2013
2014
2015
0
* Förlorade organ: 2 njurar, 1 hjärta
f'.JOT'F~
LIBRARY
Centro Nazionale Trapianu
--Coon
------
ltalianNatiooalTransplant Centre
Tile Global Vigilance and Surveillance Oatabase for Medical Products of Human Origin
~•
sr JSIC:h ID
THE NOTIFY PROJECT +
SEARCH LIBRARY
Home I Search Ubrary I Adverse occurrence ~earch
Adverse occurrence search
Adverse occurrence type
CExpand alll CClearl
Harm toa Recipient Harm to ;i Oonor Harm toa Fetus or Offspring Rlskof harm Medical Products of Human Ongm type - MPHO
CExpand all) CClearl
Organs Blood - ~-S......flr
,, S E(, cPRODUCTION
NOTIFY BOOKLET +
BACKGROUND DOCUMENTS
Medical Products of Human Origin type - MPHO
CExpandalll CClearl
Organs
Kidney
Liver
Lung
Pancreas
Smallbowel
Combined
Type not specified
Blood
Cells
..
..
Anmälan SAR/SAE • www.notifylibrary.org harm to recipient :
Njurar: 200 exempel
Hjärta: 38 exempel
Conference & Workshop on Human Transplants Identification
and Monitoring in European Union
Katowice, 6-7 October 2011
Slides: courtesy of Prof. J. Wałaszewski
Zbigniew Włodarczyk
Reporting SARE (Directive 2010/53/EU)
•
Life threatening complication to other recipients,SARE must
be reported immediately to CA (competent authority)
•
Unexpected or potential SARE, institution detecting SARE
must immediately report this to the CA
• CA must record all unexpected or potential SARE
• An annual SARE report must be produced by CA of each
member state and published by Council of Europe
• All SARE data should be shared by all CAs in European SARE
registry
Zbigniew Włodarczyk
Probability of donor's neoplasias transmission
• ONT Registry (1990-2006) - undetectd tumors 5.8/1000
donors .Only 5 or 2.9/10,000 donors tumors were
transmitted to the recipient, 10 out of 155(6.4%) or 2.2 per
10,000 recipients who received graft with a tumor
developed tumoral transmission
• Danish Registry- 13 malignant tumors among 626 donors
(2%) during 27 y. 8 were detected after organ transplantation
(1.3%) but only one transmitted neoplasia
Zbigniew Włodarczyk
Medical error: lungs ,,size error"
• A nurse put in wrong figure inta computerised organ matching
service : donar -156 cm tall, recipient 151cm
•
Surgeon was forced to compress oversized lung inta the
chest.Transplant team discovered later that the donar was
165 cm tall.
• Recipient developed pneumonia and died two months later.
The surgeon attributed the death of the patient to the wrong
size of transplanted lungs.
Zbigniew Włodarczyk
Nej
Zbigniew Włodarczyk
SAE & denominator
Total nr of tissues and cells processed (thousand units): 2010-2012 data 1000000
Total number of SAE : 2010-2012 data
887536
900000
800000
• Ot her
700000
• Human error
600000
• Equipment failure
500000
400000
• Tissue/cell defect
300000
200000
100000
2010
0
2010
2011
2012 2011
YEAR
2012
Fråga från Er /Scandiatransplant: Kan vi rapportera till Sct som rapporterar till IVO? Svar från SE :NEJ
Svar från FI : NEJ Svar från DK: NEJ Hur använder IVO anmälda avvikelser / biverkningar ?
• Nationell överblick
• Underlag inför inspektioner
• Rapportering till EU med resultat att vi får en
jämförelse SE- övriga EU länder.
Årsrapporten – Vilka uppgifter behöver IVO !
• Antal donatorer - som ni (er tx-koordinator) ansvarat för
• Antal organ som tillvaratagits (av er)
• Antal mottagna från annan -inom Norden- inom EU /EES
utom EU/EES)
Ska vi skilja på SE, Norden-EES ?
• Antal som lämnats till annan inom Norden, EES , utom EES
eller till VI
• Antal transplantationer som ni ansvarat för
• Antal mottagare
• Antal Lämnade till VI
• Ej använda
Levande / avlidna donatorer Transplantationsverksamhet 2013
• Levande Donatorer: 162 • Mottagare : 162
• Avlidna Donatorer: 150 (151)
• Mottagare: 541
(från årsrapporten till IVO )
791 organ varav 698 transplanterade (Ca 200 ”IMP/EXP”)
Lämnat till VI : 93 organ (hjärta, pancreas)
Ö-celler : 19 (16)
http://www.ivo.se/globalassets/dokument/publicerat
material/blanketter/donations--och-transplantationsverksamheter/arlig
rapport-fran-transplantationscentrum-5-4.pdf
SE / Norden ?
Inspektion:
• Olika organisation
Rikssjukvård (njurar,
tunntarm, livmoder ?)
• Att dokumenterade
rutiner, avtal, ansvar,
samtycke, spårbarhet
• Hur följs
processer/rutiner/SOP ?
• Scandiatransplant (spårbarheten)
• Informationssäkerhet ?
(behörigheter,
egenkontroller?
Dokumentation – Spårbarhet
• Tillvaratagande rapport: don ID, uppgifter om samtycke, medicinsk
information, tillvaratagandet , eventuella avvikande händelser / vem
signerar vad ?
• Spårbarhet: Donatorskod ( + SE )
•
vem har gjort vad , instrument- apparatur- lösningar som är väsentliga
för organets kvalitet,
• Tillvaratagande; vävnader + organ; vävnadsinrättning –
transplantationscentra -organ
• Bevaras i 30 år
Egenkontroller – ledningens genomgång
• Resultat från internrevisioner (även av avtalspartners) – Vertikal revision (följa en/flera donationer hela kedjan av
arbetsmoment)
• Protokoll från ledningens genomgång




Avvikelser
Revisioner
Personal
Kvalitetssystemet (behövs uppdateringar / revideras)
Övrig information från
• Certifiering av transplantationskoordinatorer ?
http://www.uemssurg.org/divisions/transplantation/transplant
coordination/ebsq-examination
• Ny rapport (mars-2015) från ECDC om HTLV-1 prevalens
(litteratur översikt avseende aktivering av HTLV efter tx hos
HTLV+ patienter)
http://ecdc.europa.eu/en/publications/Publications/geographical
distribution-areas-high-prevalence-HTLV1.pdf
***
** U. E.~' M.S. **
* . *
***
Members Area
I
Contact
UNION EUROPEENNE DES MEDECINS SPECIALISTES
EUROPEAN UNION Of MEDICAI. SPECIALISTS
Section of Surgery & European Board of Surgery
Section & Board
Divisions
Working Groups
NASCE
Surgical Education
News & Events
UEMS Surgery • Divisions • Transplantation • Transplant Coordination • EBSQ Examination
Divisions
Schedule and App lication
Certification of European Transplant Coordinator (CETC) Ge ne ral Surgery
Coloproctology
Date
Place
Application deadline tba
tba tba
Endocrine Surgery
Transplantation
Transplant Surgery
Transplant
Coordination
EBSO Examination
Application Form and Logbook for Certi fication of European Transplant Coordinator
(CETC)
Application form (pdf)
Preparatory course
Curriculum
Fellows
Application form (Word)
Download
Tack!
www.ivo.se
[email protected]
[email protected]
[email protected]