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

a S

tank

usov

a

OR

GA

NIS

ATI

ON

, CO

OR

DIN

ATI

ON

A

ND

FIN

AN

CIN

G

OF

CLI

NIC

AL

AU

DIT

OR

GA

NIS

ATI

ON

OF

EXTE

RN

AL

CLI

NIC

AL

AU

DIT

Poss

ible

appr

oach

es:

•Es

tabl

ishm

ento

fspe

cial

orga

nisa

tion

•„C

ase

by c

ase“

agre

emen

t•

Esta

blis

hmen

tofs

peci

alpr

ojec

t•

Inte

rnat

iona

laud

it se

rvic

es

1.Es

tabl

ishm

ento

fspe

cial

orga

nisa

tion

•Th

em

ost e

ffect

ive

in a

chie

ving

a sy

stem

atic

regu

lars

yste

mof

audi

ts•

Mai

nta

sks

ofth

eor

gani

satio

n:–

To s

ettle

outa

con

sist

enta

udit

prog

ram

me

–To

dev

elop

eth

epr

ogra

mm

efo

r con

tinui

ngau

dits

–To

man

age

the

prac

tical

prep

arat

ions

, con

tact

s,

orga

nisa

tion

ofau

dit v

isits

, rep

ortin

gan

dfin

anci

alm

atte

rs

3Ta

mpe

re, 8

.-10

.9 2

008

Han

a S

tank

usov

a

1.Es

tabl

ishm

ento

fspe

cial

orga

nisa

tion

(con

t.)

The

audi

tors

are

mos

t typ

ical

lyem

ploy

edfo

r eac

hin

divi

dual

audi

t fro

mth

epo

olof

heal

thca

re p

rofe

ssio

nals

base

don

spe

cial

agre

emen

ts. T

hey

shou

ldbe

fam

iliar

with

the

audi

t met

hodo

logy

Han

a S

tank

usov

a4

Tam

pere

, 8.-

10.9

200

8

1.Es

tabl

ishm

ento

fspe

cial

orga

nisa

tion

(con

t.)

The

spec

ialo

rgan

isat

ion

can

be:

–G

over

nmen

tbod

y–

Priv

ate

com

pany

•N

on-p

rofit

com

pany

•C

omm

erci

alco

mpa

ny

Han

a S

tank

usov

aTa

mpe

re, 8

.-10

.9 2

008

5

2. In

divi

dual

„cas

eby

cas

e“ag

reem

ent

•Th

ein

divi

dual

peer

revi

ewty

pe o

faud

it is

usua

llyba

sed

on s

peci

alag

reem

ent

betw

een

two

heal

thca

re u

nits

.•

The

audi

t pro

gram

me

and

impl

emen

tatio

nca

nbe

agre

edve

ryfr

eely

betw

een

units

.•

This

type

ofa

udit

does

not e

nsur

eco

ntin

uity

and

wid

erun

iform

ity in

the

coun

try.

Tam

pere

, 8. -

10.9

200

86

Han

a S

tank

usov

a

3. E

stab

lishm

ento

fspe

cial

proj

ect

•Th

eop

tion

ofsp

ecia

lpro

ject

can

beve

ryco

mpr

ehen

sive

and

effe

ctiv

ein

a s

hort

term

. It

can

beea

sily

supp

orte

dan

dfu

nded

and

impo

rtan

tpa

rtne

rsan

dex

pert

ise

can

bein

volv

edth

roug

hth

epr

ojec

tstr

uctu

re. S

uch

proj

ectc

anpr

ovid

ehi

ghim

petu

sto

war

dsth

ecr

eatio

nof

the

futu

reau

dit s

yste

m.

•Im

port

antd

raw

back

isth

atth

epr

ojec

tits

elf

ison

lyte

mpo

rary

activ

ityan

ddo

esno

t pro

vide

a co

ntin

uous

engi

nefo

r on-

goin

gex

tern

alcl

inic

alau

dit

Han

a S

tank

usov

aTa

mpe

re, 8

.-10

.9 2

008

7

4. In

tern

atio

nala

udit

serv

ices

•C

anbe

usef

ulin

pro

vidi

ngso

me

„mod

el

audi

ts“

in th

epr

oces

sof

deve

lopi

ngna

tiona

lorg

anis

atio

nfo

r clin

ical

audi

ts.

•Th

edr

awba

ckof

this

optio

nis

that

inte

rnat

iona

lse

rvic

esfo

r clin

ical

audi

t ar

e no

t wid

ely

avai

labl

eor

are

avai

labl

eon

lyun

ders

peci

alco

nditi

ons

orfo

r lim

ited

appl

icat

ions

Han

a S

tank

usov

aTa

mpe

re, 8

. -10

.9 2

008

8

Aud

itors

•Pr

ofes

sion

al c

ompe

tenc

ean

dlo

ng-te

rm

clin

ical

expe

rienc

e.•

Invo

lvem

enti

n cl

inic

alw

ork

ata

spec

ialit

y si

mila

rto

the

one

to b

eau

dite

d.•

Spec

ific

trai

ning

in th

ege

nera

laud

it pr

oced

ure

and

tech

niqu

esas

wel

las

in

agre

edau

dit p

rogr

amm

ean

dcr

iteria

ofgo

odpr

actic

e•

Prin

cipl

eof

inde

pend

ence

in a

udits

Han

a S

tank

usov

aTa

mpe

re, 8

.-10

.9 2

008

9

Mul

tidis

cipl

inar

yna

ture

ofte

am

•C

onve

ntio

nalr

adio

logy

:rad

iolo

gist

and

radi

ogra

pher

•M

ore

soph

istic

ated

radi

olog

y: ra

diol

ogis

t, m

edic

alph

ysic

ist,

radi

ogra

pher

•N

ucle

arm

edic

ine:

phy

sici

an-N

M s

peci

alis

t, m

edic

alph

ysic

ist,

tech

nolo

gist

+ra

diop

harm

acis

t•

Rad

ioth

erap

y: ra

diat

ion

onco

logi

st, m

edic

alph

ysic

ist,

RTT

Han

a S

tank

usov

aTa

mpe

re, 8

.-10

.9 2

008

10

Freq

uenc

yof

audi

ts

•C

linic

alau

dits

shou

ldbe

a sy

stem

atic

activ

ityw

ithre

gula

rre-

audi

ting

afte

rce

rtai

npe

riod

orw

hene

vert

here

appe

ars

spec

ific

need

ofex

tra

audi

t.

•Th

eau

dit c

ycle

shou

ldbe

com

plet

ed,

incl

udin

gth

eac

tions

for i

mpr

ovem

ent

base

don

the

audi

t rec

omm

enda

tions

Freq

uenc

yof

audi

ts

•Th

ein

tern

alcl

inic

alau

dits

shou

ldbe

a co

ntin

uous

activ

ityw

ithth

eai

mof

havi

ngsi

gnifi

cant

part

sof

the

over

alla

udit

prog

ram

me

cove

red

once

a ye

ar•

The

optim

alfr

eque

ncy

for e

xter

nalc

linic

alau

dit

may

depe

ndon

loca

linf

rast

ruct

ure

and

the

inte

nsity

ofo

ther

qual

ityre

view

activ

ities

. Min

imum

freq

uenc

yof

five

year

sse

ems

to b

ere

ason

able

aim

.

CO

OR

DIN

ATI

ON

A s

peci

alna

tiona

lorr

egio

nal

advi

sory

grou

pof

clin

ical

expe

rts

may

beus

eful

in

the

over

allc

oord

inat

ion

and

deve

lopm

ent

ofth

ecl

inic

alau

dit i

mpl

emen

tatio

n,

crite

riaan

dpr

oced

ures

. A re

pres

enta

tive

ofge

nera

lqua

lity

asse

smen

tbod

ies

and

ofth

ena

tiona

lrad

iatio

npr

otec

tion

auth

ority

shou

ldbe

also

part

oft

hegr

oup

Han

a S

tank

usov

aTa

mpe

re, 8

. -10

.9 2

008

13

Nat

iona

lorr

egio

nal

advi

sory

grou

p

The

grou

psh

ould

bepr

efer

ably

esta

blis

hed

by

the

Hea

lthM

inis

try

orot

herg

over

nmen

tor

gani

zatio

n(to

ens

ure

appr

opria

teau

thor

ityan

dfin

anci

ng)

•Ta

sks

ofth

ead

viso

rygr

oup:

•To

giv

ead

vice

and

reco

mm

enda

tion

on th

eov

eral

lim

plem

enta

tion

ofcl

inic

alau

dits

in th

eco

untr

y•

To d

eter

min

eco

mpe

tenc

ean

dtr

aini

ngof

audi

tors

, prio

ritie

sof

asse

ssm

ents

, crit

eria

ofgo

odpr

actic

ean

dth

epr

oced

ures

Han

a S

tank

usov

aTa

mpe

re, 8

. -10

.9 2

008

14

Nat

iona

lorr

egio

nal

advi

sory

grou

p(c

ont.)

–To

pro

vide

natio

nals

urve

ysan

dsu

mm

arie

sof

the

resu

ltsor

outc

omes

ofex

tern

alcl

inic

alau

dits

–To

follo

w-u

pin

tern

atio

nald

evel

opm

ento

fcl

inic

alau

dits

and

prov

ide

mut

uale

xcha

nge

ofin

form

atio

n

Han

a S

tank

usov

aTa

mpe

re, 8

. -10

.9 2

008

15

The

role

ofs

cien

tific

/pro

fess

iona

lsoc

ietie

s

Scie

ntifi

can

d/or

prof

essi

onal

soci

etie

sm

ust

play

anim

port

antr

ole

in th

ede

velo

pmen

tof

clin

ical

audi

tsto

the

max

imum

ben

efit

ofra

diol

ogic

alhe

alth

care

uni

ts. T

hey

shou

ldbe

invo

lved

in:

–D

evel

opin

gcr

iteria

ofgo

odpr

actic

esfo

r the

eval

uatio

nof

clin

ical

audi

ts–

Prov

idin

gpr

actic

alad

vice

and

supp

ort f

or th

ees

tabl

ishm

ento

fapp

ropr

iate

clin

ical

audi

t or

gani

zatio

nor

prac

tical

solu

tions

on c

arry

ing

outc

linic

alau

dit H

ana

Sta

nkus

ova

Tam

pere

, 8.-

10.9

200

816

The

role

ofs

cien

tific

/pro

fess

iona

lsoc

ietie

s(c

ont.)

-Th

esu

ppor

t oft

hepr

ofes

sion

also

ciet

ies

in

the

prac

tical

impl

emen

tatio

nw

illim

prov

ege

nera

lcre

dibi

lity,

acc

epta

nce

and

mot

ivat

ion

ofth

ecl

inic

alau

dits

by d

iffer

ent

heal

thca

re p

rofe

ssio

nals

atth

eun

itsto

be

audi

ted

Han

a S

tank

usov

aTa

mpe

re, 8

. -10

.9 2

008

17

FIN

AN

CIN

G

The

cost

ofcl

inic

alau

dit c

onsi

sts

of:

–La

bour

cost

–M

ater

ialc

ost

–C

ostf

or tr

avel

and

acco

mm

odat

ion

–(fe

efo

r the

oper

atio

nof

the

spec

ial

orga

niza

tion)

16H

ana

Sta

nkus

ova

Tam

pere

, 8. -

10.9

200

8

Labo

urco

st

•Th

egr

eate

stco

ntrib

utio

nto

the

over

allc

osts

ofth

eau

dit

•C

anbe

upto

the

expe

nditu

reof

seve

ral

man

days

-dep

endi

ngof

the

size

ofau

dit

team

(2-3

aud

itors

) and

the

leng

thof

audi

t(2-

5 da

ys)

•It

ises

sent

ialt

hatt

heco

sts

ofex

tern

alau

dit

are

cons

ider

edin

the

annu

albu

dget

oft

hehe

alth

care

uni

t

Han

a S

tank

usov

aTa

mpe

re, 8

.-10

.9 2

008

19

Mat

eria

lcos

t

•So

me

part

ofe

xter

nalc

linic

alau

dits

can

beso

met

imes

impl

emen

ted

by p

osta

lm

etho

ds.

•M

ater

iale

xpen

ditu

reis

gene

rally

not

sign

ifica

nt, d

epen

dsgr

eatly

on th

ety

pe o

fac

tiviti

esin

clud

edin

the

audi

t. Th

ese

are

typi

cally

capi

talc

osts

need

edto

mai

ntai

ndo

sim

etric

and

othe

rtec

hnic

aleq

uipm

ent.

Han

a S

tank

usov

aTa

mpe

re, 8

. -10

.9 2

008

20

Cos

tfor

trav

elan

dac

com

mod

atio

n

•Th

ese

expe

nditu

res

are

mor

e st

raig

htfo

rwar

dto

be

estim

ated

and

shou

ldin

clud

eth

etr

avel

and

acco

mm

odat

ion

cost

sfo

r the

audi

t tea

m.

Han

a S

tank

usov

aTa

mpe

re, 8

. -10

.9 2

008

21

Fina

ncin

g

•Fo

r int

erna

laud

itsth

efin

anci

ngis

stra

ight

forw

ard

as th

eau

dits

are

part

ofn

orm

alop

erat

ion

ofun

it.

•Fo

r ext

erna

laud

its, t

hefin

anci

ngm

aybe

com

ea

cruc

ialp

oint

bec

ause

the

cost

can

bea

sign

ifica

ntad

ditio

nto

the

units

‘s n

orm

alex

pedi

ntur

es

Han

a S

tank

usov

aTa

mpe

re, 8

. -10

.9 2

008

22

Fina

ncin

g

•W

hen

clin

ical

audi

tsar

e ca

rrie

dou

tby

spec

ial

orga

niza

tions

(priv

ate

orse

mi-p

rivat

e) th

eop

erat

ion

has

to b

efin

ance

dei

ther

tota

llyor

part

lyby

intr

oduc

ing

fees

to th

ein

stitu

tions

audi

ted.

•Th

efe

essh

ould

corr

espo

ndto

the

real

cost

ofth

eop

erat

ion

with

outt

ryin

gto

mak

ean

ypr

ofit

(a n

on–p

rofit

org

aniz

atio

n).

•In

fully

priv

ate

com

pani

esov

er-c

harg

ing

ispo

ssib

leH

ana

Sta

nkus

ova

Tam

pere

, 8. -

10.9

200

823

Fina

ncin

g

•W

hen

clin

ical

audi

tsar

e or

gani

zed

on m

utua

lag

reem

ents

betw

een

the

inst

itutio

nto

be

audi

ted

and

the

inst

itutio

npr

ovid

ing

the

audi

tors

, or

audi

tors

serv

ing

as in

depe

nden

t exp

erts

in th

eir

pers

onal

capa

city

, the

labo

urco

stm

ight

beag

reed

to a

leve

lwhi

chis

low

erth

anth

ere

alco

stor

bem

anag

edby

the

prin

cipl

eof

reci

proc

ity.

•Th

isap

proa

chis

not g

ener

ally

reco

mm

enda

ble

due

to th

epr

oble

ms

ofno

n-un

iform

ity a

ndla

ckof

inde

pend

ence

.Ta

mpe

re, 8

. -10

.9 2

008

24H

ana

Sta

nkus

ova