For the purpose of this survey, an in vitro diagnostic device
(IVD) refers to any assay, instrument, equipment or apparatus,
or control/calibrator, which is intended to be used in vitro for
the examination of a specimen derived from the human body.
7.
For the last financial year, what was the range of your laboratory’s
total annual turnover?
1
Please ensure your responses to this survey reflect only the
operations of the laboratory to whom this survey is addressed.
2
General Information / Demographics
5
3
4
6
1.
Is your laboratory a stand-alone business or part of a larger
group of laboratories within a corporate entity, hospital, university
or health network?
1
Don’t Know
2
One laboratory operating as a stand alone business
3
One of a number of laboratories
8.
Less than $1,000,000
$1,000,000 - $5,000,000
$5,000,001- $10,000,000
$10,000,001- $20,000,000
$20,000,001- $50,000,000
More than $50,000,000
What approximate percentage of this turnover was related to IVD
testing or related activities?
%
Types of IVDs in the market
2.
In which state or territory is your laboratory located?
TAS
VIC
ACT
NSW
3.
QLD
NT
WA
SA
1
2
3
4
5
9.
6
7
8
Which of the following categories best describes your laboratory?
(You may tick more than one box)
1
Public laboratory
2
Private laboratory
3
Children’s hospital laboratory
4
Genetics laboratory
5
Academic laboratory
6
Other (Please specify)
Does your laboratory perform in-house IVD tests?
An in-house test is a test that is developed de novo, or modified
from a published source, or modified or adapted from any other
source, within the confines or scope of a laboratory, validated for
use within that laboratory only, and is not supplied for use
outside that laboratory.
Yes
No
1
2
Don’t know
3
10. Please estimate the number of different types of assays
Does you laboratory offer or has it been established to provide a
specialist capability in certain disciplines? (E.g. newborn screening,
immunology etc)
Yes
1
4c
5.
2
Don’t know
(Go to Q5)
3
If yes, in which discipline/s does your laboratory specialise?
Does your laboratory obtain Medicare reimbursement for any of
the tests it performs?
Yes
1
6.
No
(Go to Q5)
Commercial
assays
Modified
commercial
assays
In-house
assays
4a
your laboratory uses in each of the following categories,
including those that are a) commercial assays, b) modified
commercial assays (where modification may apply to the assay itself
or to the process of performing the particular test) and c) assays
developed in-house.
No
2
Don’t know
A.
Haematology
B.
Bacteriology/microbiology
C.
Histopathology
D.
Biochemistry
E.
Cytopathology
F.
Serology
G.
Immunology
H.
Molecular genetics
I.
Biochemical genetics
J.
Transfusion medicine
K.
Endocrinology
L.
Other
3
What is the total number of employees for your laboratory?
Number of pathologists and supervising Senior Scientists
Number of scientists and technicians
Number of other employees
Total
Impact of regulatory proposal
In the proposed new regulatory framework, IVDs are to be
classified using a set of rules. The TGA has proposed that the
responsibility for IVD risk classification will lie with
manufacturers, who will classify their products using a set of
rules. The TGA will then confirm or revise the risk class upon
receipt of the application. The TGA has proposed that there be
four risk classes (see below) and that a given product’s risk
classification will determine the requirements to be met prior to
its supply on the Australian market, with requirements increasing
as risk level increases. Class I represents the lowest risk class,
while Class IV represents the highest risk class.
11.
Total
No
1
15a
Don’t know
2
3
Is your laboratory accredited with NATA/RCPA? (The joint
accreditation scheme provided by the National Association of Testing
Authorities Australia in conjunction with the Royal College of Pathologists of
Australasia)
Yes
No
1
Don’t know
2
3
%
15b
Does your laboratory hold any other quality accreditation?
%
Yes
No
(Go to Q16a)
1
Don’t know
(Go to Q16a)
2
3
%
%
15c
If yes, who is your laboratory accredited with?
16a
Go to question 18 if you do not develop in-house tests
100 %
Does your laboratory perform small volume tests?
A small volume test is one that is performed infrequently (20 times
per month or less), because either the test is used to detect a
disease that occurs with very low incidence, or the technology
used in the assay is not widely available.
Yes
Does your laboratory keep records of the test development and
validation data for any of the IVDs it develops in-house?
Yes
Don’t know
No
1
13.
Is this position full-time? (i.e. Does this person devote more than 75% of a
normal working week to quality management)?
Yes
Looking at the total number of IVDs that your laboratory uses (as
identified in Question 10), please estimate what approximate
percentage of these IVDs fall into each of the following proposed
risk classes:
Class IV - High public health risk
E.g. IVDs used to screen blood or tissue donations
etc. for the presence of serious disease causing or
life-threatening pathogens.
Class III – High personal risk / Moderate public
health risk
E.g. IVDs used in the diagnosis of rubella infection in
pregnancy, IVDs for the detection of some cancer
markers.
Class II – Low public health risk / Moderate
personal risk
E.g. IVDs for pregnancy testing, thyroid stimulating
hormone, etc.
Class I – No public health risk / Low personal risk
E.g. Media used to identify or infer the identity of a
micro-organism, IVD instrumentation.
12.
14b
2
3
No
(Go to Q17)
2
1
What approximate percentage of your in-house IVDs are produced
because there are a) no available commercial alternatives, b) the
in-house IVD is more cost effective, c) the in-house IVD is
technically superior, or d) for some other reason?
16b
Don’t know
(Go to Q17)
3
If yes, what approximate percentage of the in-house tests your
laboratory develops, do you have test development and
validation data records for?
%
A.
No commercial IVDs available
%
B.
In-house IVDs are more cost effective
%
C.
In-house IVDs are technically superior
%
D.
Other (please specify the reason/s below)
%
17.
14a
Does your laboratory have a quality manager?
Yes
1
No
(Go to Q15a)
2
Don’t know
(Go to Q15a)
3
What approximate percentage of the in-house tests that your
laboratory develops could be characterised as a) a published
method, b) a modified published method, c) a de novo method, or
d) modification of a commercial IVD?
A.
Published method
%
B.
Modified published method
%
C.
De novo method
%
D.
Modification of a commercial IVD
%
In its discussion paper (see front cover), the TGA has
proposed a number of options for increasing its level of
regulatory oversight of in-house IVD tests.
18a
What do you think will be the impact on your laboratory, of
increased regulation of in-house tests by the TGA?
18b
In what ways do you think increased regulatory oversight of
in-house IVD tests by the TGA could deliver benefits to your
laboratory and the wider industry?
19.
Approximately how long did this questionnaire take you to
complete?
Hours
Minutes
Thank-you for assisting us with this survey.
PLEASE RETURN YOUR COMPLETED SURVEY FORM
TO PIAZZA CONSULTING IN THE REPLY PAID
ENVELOPE PROVIDED BY DATE.
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Woden ACT 2606
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