International Workshop on Practical Implementation of Clinical Audit for Medical Exposure to Ionizing Radiation 8–10 September 2008, Tampere, Finland Hannu Järvinen STUK [email protected] Presentation of the draft EC Guideline: Purpose, scope and definitions
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Transcript
Inte
rnat
iona
l Wor
ksho
p on
Pra
ctic
al Im
plem
enta
tion
ofC
linic
al A
udit
for M
edic
al E
xpos
ure
to Io
nizi
ng R
adia
tion
8–10
Sep
tem
ber 2
008,
Tam
pere
, Fin
land
Han
nuJä
rvin
en
ST
UK
hann
u.ja
rvin
en@
stuk
.fi
Pre
sent
atio
n of
the
dra
ft E
C G
uide
line:
Pur
pose
, sco
pe a
nd
defi
niti
ons
Tam
pere
200
8090
8 H
Jär
vine
n 10
:00
Dra
ftE
C G
uide
line
on
clin
ical
audi
t
to p
rovi
de g
uida
nce
on c
linic
al a
udit
ing
incl
udin
g op
tim
al s
tand
ardi
zati
on w
hich
cou
ld
impr
ove
impl
emen
tati
on o
f A
rtic
le 6
.4 o
f C
ounc
il D
irec
tive
97/
43/ E
UR
AT
OM
to p
rovi
de c
ompr
ehen
sive
info
rmat
ion
on
exis
ting
pro
cedu
res
and
crit
eria
fo
r c
lin
ica
l a
ud
its in
RA
DIO
LO
GIC
AL
pra
cti
ce
s:
dia
gn
osti
c r
ad
iolo
gy, n
uc
lea
r m
ed
icin
e a
nd
ra
dio
the
rap
yto
cla
rify
the
ter
min
olog
y us
ed, d
efin
e th
e co
re e
lem
ents
of
Clin
ical
aud
it a
nd p
rovi
de
exam
ples
of
the
vari
ous
appr
oach
es a
nd g
ood
prac
tice
Pur
pose
Tam
pere
200
8090
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Jär
vine
n 10
:00
EC
Clin
ical
audi
tpr
ojec
t
The
gui
danc
e w
ill
enab
le t
he m
embe
r S
tate
s to
ad
op
t th
e m
od
el
of
cli
nic
al a
ud
it w
ith
re
sp
ec
t to
th
eir
n
ati
on
al
leg
isla
tio
n
an
d a
dm
inis
tra
tive
p
rovis
ion
s.
Pur
pose
Tam
pere
200
8090
8 H
Jär
vine
n 10
:00
Dra
ftE
C G
uide
line
on
clin
ical
audi
t
The
gui
delin
e de
als
wit
h al
l typ
es a
nd le
vels
of
clin
ical
au
dit,
and
is a
pplic
able
to
both
inte
rnal
and
ext
erna
l au
dits
.
It is im
po
rta
nt
to r
ec
og
niz
e t
ha
t th
is g
uid
elin
e
is n
ot
a le
ga
l re
qu
ire
me
nt.
Ac
co
rdin
g t
o t
he
M
ED
dir
ec
tive
, c
lin
ica
l a
ud
its s
ho
uld
be
c
arr
ied
ou
t in
ac
co
rda
nc
e w
ith
na
tio
na
l p
roc
ed
ure
s. T
he
pu
rpo
se
of
this
gu
ide
lin
e is
to g
ive
re
co
mm
en
da
tio
ns a
nd
hig
hlig
ht
so
me
p
ossib
le “
na
tio
na
l p
roc
ed
ure
s”.
Pur
pose
Tam
pere
200
8090
8 H
Jär
vine
n 10
:00
Dra
ftE
C G
uide
line
on
clin
ical
audi
t
Thi
s gu
idel
ine
will
def
ine
the
list
of t
opic
s w
hich
sho
uld
be c
over
ed b
y cl
inic
al a
udit
sT
he a
ctua
l cri
teri
a of
goo
d pr
acti
ce a
re
disc
usse
d to
som
e ex
tent
onl
y on
gen
eric
le
vels
. Fo
r th
e m
ost
deta
iled
crit
eria
of
good
pr
acti
ce, f
or s
peci
fic
exam
inat
ions
or
trea
tmen
ts, t
he g
uide
line
can
only
de
mon
stra
te t
he n
atur
e or
exe
mpl
ify
such
cr
iter
ia, t
oget
her
wit
h so
me
orie
ntat
ion
how
th
ese
can
be d
evel
oped
.
Pur
pose
Tam
pere
200
8090
8 H
Jär
vine
n 10
:00
Dra
ftE
C G
uide
line
on
clin
ical
audi
t
The
gui
delin
e ha
s be
en d
esig
ned
to b
e fo
r ap
prop
riat
e R
AD
IOLO
GIC
AL
staf
f (a
ll pr
ofes
sion
al g
roup
s), h
ospi
tal m
anag
emen
t,
audi
ting
org
aniz
atio
ns a
nd r
egul
ator
y bo
dies
, in
ord
er t
o im
prov
e th
eir
awar
enes
s of
the
ir
resp
onsi
bilit
ies
and
duti
es.
Pur
pose
Tam
pere
200
8090
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Jär
vine
n 10
:00
Dra
ftE
C G
uide
line
on
clin
ical
audi
t
Impr
oved
clin
ical
aud
it w
ill t
hen
yiel
d m
ulti
ple
bene
fits
to
the
heal
th c
are
syst
em:
prov
isio
n of
ato
ol f
or q
ualit
y im
prov
emen
tim
prov
emen
t of
pra
ctic
ere
cogn
itio
n fo
r qu
alit
y an
d aw
aren
ess
of g
ood
prac
tice
sre
cogn
itio
n of
out
date
d pr
acti
cem
otiv
atio
n of
sta
ff t
o in
crea
se q
ualit
yim
prov
emen
t of
loca
l sta
ndar
ds a
nd a
dher
ence
to
nati
onal
sta
ndar
dspr
even
tion
aga
inst
liti
gati
onim
prov
emen
t of
com
mun
icat
ion
wit
hin
the
inst
itut
ions
reve
alin
g w
eak
poin
tspr
omot
ing
deve
lopm
ent
of q
ualit
y sy
stem
s.
Pur
pose
Tam
pere
200
8090
8 H
Jär
vine
n 10
:00
Dra
ftE
C G
uide
line
on
clin
ical
audi
t
Thr
ough
add
ress
ing
tech
nica
l, fi
nanc
ial a
nd
clin
ical
pro
visi
on f
or h
igh
qual
ity
RA
DIO
LOG
ICA
L pr
oced
ures
, the
mai
n be
nefi
ciar
y of
enh
ance
d cl
inic
al a
udit
sho
uld
even
tual
ly b
e th
e pa
tien
t.
Pur
pose
Tam
pere
200
8090
8 H
Jär
vine
n 10
:00
Dra
ftE
C G
uide
line
on
clin
ical
audi
t
Clin
ical
aud
it is
“A
sys
tem
atic
exa
min
atio
n or
rev
iew
of
med
ical
RA
DIO
LOG
ICA
L pr
oced
ures
whi
ch s
eeks
to
impr
ove
the
qual
ity
and
the
outc
ome
of p
atie
nt c
are,
th
roug
h st
ruct
ured
rev
iew
whe
reby
R
AD
IOLO
GIC
AL
prac
tice
s, p
roce
dure
s, a
nd
resu
lts
are
exam
ined
aga
inst
agr
eed
stan
dard
sfo
r go
od m
edic
al R
AD
IOLO
GIC
AL
proc
edur
es,
wit
h m
odif
icat
ions
of
the
prac
tice
s w
here
in
dica
ted
and
the
appl
icat
ion
of n
ew
stan
dard
s if
nec
essa
ry".
Def
init
ions
Tam
pere
200
8090
8 H
Jär
vine
n 10
:00
Dra
ftE
C G
uide
line
on
clin
ical
audi
t
Thi
s G
uide
line
will
not
aim
at
chan
ging
th
e C
linic
al A
udit
def
init
ion
but
is t
ryin
g to
cla
rify
its
prof
ound
m
eani
ng a
nd r
ecom
men
ded
appl
icat
ion
Def
init
ions
Tam
pere
200
8090
8 H
Jär
vine
n 10
:00
Dra
ftE
C G
uide
line
on
clin
ical
audi
t
It is
obv
ious
fro
m t
he d
efin
itio
n th
at a
ll gr
ades
of
staf
f (a
ll pr
ofes
sion
als)
of
med
ical
car
e m
ust
be in
volv
edIt
is a
tru
ly m
ulti
-dis
cipl
inar
y, m
ulti
-pr
ofes
sion
al a
ctiv
ity.
T
he t
erm
"m
edic
al a
udit
" is
som
etim
es
used
whe
n th
e ac
tivi
ty is
con
fine
d to
th
e w
ork
and
serv
ice
that
phy
sici
ans,
al
one
Def
init
ions
Tam
pere
200
8090
8 H
Jär
vine
n 10
:00
Dra
ftE
C G
uide
line
on
clin
ical
audi
t
Clin
ical
aud
it is
not
con
side
red
to t
arge
t on
a p
erfo
rman
ce o
n an
indi
vidu
alon
a s
ingl
e pa
tien
t.
Def
init
ions
Tam
pere
200
8090
8 H
Jär
vine
n 10
:00
Dra
ftE
C G
uide
line
on
clin
ical
audi
t
Clin
ical
aud
it is
not
:re
sear
chqu
alit
y (s
yste
m)
audi
t to
ver
ify
that
th
e qu
alit
y sy
stem
s co
nfor
ms
to a
qu
alit
y st
anda
rd
a re
gula
tory
insp
ecti
on n
or a
ny
othe
r re
gula
tory
act
ivit
y
Def
init
ions
Tam
pere
200
8090
8 H
Jär
vine
n 10
:00
Dra
ftE
C G
uide
line
on
clin
ical
audi
t
Re
se
arc
h is
a s
yste
mat
ic in
vest
igat
ion
to in
crea
se t
he s
um o
f ou
r kn
owle
dge.
Fo
r cl
inic
al a
udit
, the
aim
of
rese
arch
is
to
dete
rmin
e w
hat
is a
goo
d pr
acti
ce, w
hile
aud
it it
self
sho
uld
ask
the
ques
tion
: “A
re w
e ac
tual
ly
follo
win
g go
od p
ract
ice?
”
Def
init
ions
Tam
pere
200
8090
8 H
Jär
vine
n 10
:00
Dra
ftE
C G
uide
line
on
clin
ical
audi
t
Qu
ali
ty (
syste
m)
au
dit
is a
n au
dit
to v
erif
y th
at t
he q
ualit
y sy
stem
(Q
S)
of t
he
orga
niza
tion
con
form
s to
a g
iven
qua
lity
syst
em s
tand
ards
, for
exa
mpl
e IS
O 9
001
(IS
O, 1
994)
. The
ass
essm
ent
of t
he Q
S is
us
ually
car
ried
out
by
an in
depe
nden
t bo
dy (
a ce
rtif
icat
ion
body
), w
hich
will
is
sue
a ce
rtif
icat
e th
at t
he Q
S is
in
conf
orm
ance
wit
h th
e se
lect
ed q
ualit
y st
anda
rd.
Def
init
ions
Tam
pere
200
8090
8 H
Jär
vine
n 10
:00
Dra
ftE
C G
uide
line
on
clin
ical
audi
t
Re
gu
lato
ry i
nsp
ec
tio
nis
an
insp
ecti
on b
y a
regu
lato
ry b
ody
in o
rder
to
veri
fy t
hat
RA
DIO
LOG
ICA
L pr
acti
ces
are
carr
ied
out
in c
onfo
rman
ce w
ith
lega
l req
uire
men
ts
(law
s, s
tatu
tes,
reg
ulat
ions
). T
hese
are
ty
pica
lly u
nam
bigu
ous
wit
h bi
ndin
g re
quir
emen
ts. N
on-c
ompl
ianc
e ca
n le
ad t
o en
forc
emen
t ac
tion
s.
Def
init
ions
Tam
pere
200
8090
8 H
Jär
vine
n 10
:00
Dra
ftE
C G
uide
line
on
clin
ical
audi
t
Goo
d pr
acti
ceis
the
pra
ctic
e w
hich
can
be
reco
mm
ende
d ba
sed
on t
he m
ost
rece
nt
cons
ider
atio
ns o
f ev
iden
ce b
ased
dat
a, lo
ng
term
exp
erie
nce
and
know
ledg
e ga
ined
on
the
nece
ssar
y st
ruct
ure,
pro
cess
and
ou
tcom
e.
Goo
d pr
acti
ce is
not
a p
erm
anen
t co
ncep
t bu
t sh
ould
ev
olve
wit
h th
e ge
nera
l dev
elop
men
t of
evi
denc
e ba
sed
med
icin
e, m
edic
al r
adio
logi
cal e
quip
men
t an
d te
chni
ques
.S
omet
imes
goo
d pr
acti
ce h
as t
o be
ada
pted
to
the
avai
labl
e lo
cal f
acili
ties
and
res
ourc
es.
Due
to
loca
l si
tuat
ions
, a u
nive
rsal
ly a
gree
d go
od p
ract
ice
(opt
imiz
ed p
ract
ice)
may
be
diff
icul
t to
ach
ieve
for
a
whi
le b
ut s
houl
d be
con
side
red
as a
n ul
tim
ate
aim
.
Def
init
ions
Tam
pere
200
8090
8 H
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vine
n 10
:00
”An
exam
inat
ion,
by
qual
ifie
dpe
rson
s, o
f th
e bo
oks
and
acco
unts
of a
bus
ines
s, p
ublic
offi
ceor
unde
rtak
ing
to
prev
ent
ordi
scov
erfr
aud
on t
he p
art
of a
pe
rson
kee
ping
them
”
Au
dit
ors
mu
st
be
ind
ep
en
de
nt
fro
mth
e
org
an
iza
tio
nto
be
au
dit
ed
, i.
e.,
th
e
au
dit
ors
sh
ou
ldn
ot
be
resp
on
sib
lefo
r th
e p
roc
ed
ure
sto
be
asse
sse
d.
Dra
ftE
C G
uide
line
on
clin
ical
audi
tD
efin
itio
ns
Tam
pere
200
8090
8 H
Jär
vine
n 10
:00
Dra
ftE
C G
uide
line
on
clin
ical
audi
t
How
ever
, not
ific
atio
n of
the
au
thor
itie
s ar
e no
t to
be
excl
uded
in
case
the
ass
essm
ent
reve
als
seri
ous
prob
lem
s or
non
-con
form
itie
s w
hich
m
ay e
ndan
ger
the
safe
ty o
f pa
tien
ts
or s
taff
In s
uch
case
s, t
he a
udit
ors
shou
ld
imm
edia
tely
not
ify
the
hosp
ital
m
anag
emen
t of
the
fin
ding
s an
d in
form
reg
ulat
ory
auth
orit
ies
acco
rdin
g to
the
nat
iona
l law
if
nece
ssar
y. D
efin
itio
ns
Tam
pere
200
8090
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vine
n 10
:00
Dra
ftE
C G
uide
line
on
clin
ical
audi
t
Clin
ical
aud
it s
houl
d be
a s
yste
mat
ic
and
cont
inui
ng a
ctiv
ity,
whe
reby
in
tern
al a
nd e
xter
nal a
udit
pro
cedu
res
are
of e
qual
impo
rtan
ce in
ord
er t
o ac
hiev
e op
tim
al o
utco
mes
.
Def
init
ions
Tam
pere
200
8090
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Jär
vine
n 10
:00
Dra
ftE
C G
uide
line
on
clin
ical
audi
t
Inte
rna
l a
ud
its
and
self
-ass
essm
ents
are
ca
rrie
d ou
t w
ithi
n th
e he
alth
car
e un
it a
s pa
rt
of it
s ov
eral
l qua
lity
assu
ranc
e pr
oced
ures
.T
he p
rinc
iple
of
inde
pend
ence
is im
plem
ente
d w
hene
ver
poss
ible
by
nom
inat
ing
audi
tors
fro
m
sub-
unit
s or
dep
artm
ents
of
the
inst
itut
ion
diff
eren
t fr
om t
he s
ub-u
nit
to b
e au
dite
d.
For
smal
l uni
ts in
tern
al a
udit
s ca
n ta
ke m
ore
a fo
rm o
f a
self
-ass
essm
ent
rath
er t
han
actu
al
audi
t.
Def
init
ions
Tam
pere
200
8090
8 H
Jär
vine
n 10
:00
Dra
ftE
C G
uide
line
on
clin
ical
audi
t
Ex
tern
al a
ud
its
are
carr
ied
out
by a
n ex
tern
al
audi
ting
bod
y or
aud
itor
s, in
depe
nden
t fr
om
the
orga
niza
tion
to
be a
udit
ed.
An
exte
rnal
aud
it c
ould
hel
p to
ass
ure
good
pr
acti
ce, a
s it
mig
ht b
e di
ffic
ult
or in
adeq
uate
to
rev
eal p
robl
ems
only
by
inte
rnal
eff
orts
.
Def
init
ions
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