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The Nordic immunohistochemical Quality Control
(NordiQC) quality assessment scheme provides fully
comprehensive service consisting of
► Assessment of tests of immunohistochemical stains on NordiQC multitissue block sections
as indicated in
Assessment
method below.
► A general review of each assessment run on the website
www.nordiqc.org including:
-
photos of optimal and insufficient stains with
explanations and hints for improvement
-
recommendations for optimizing staining protocols
-
examples of complete protocols for optimal
staining of each epitope (based on different antibodies and systems,
when appropriate)
► Individual e-mail information including
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assessment scores for each stain (certificate
of participation for proficiency testing)
-
explanation of probable causes of insufficient
(borderline or poor)
stains
-
recommendations
for improvement - tailored guidelines for the platform used
-
e-mail alerts and information about new runs,
website updates etc.
► Participant help line by e-mail (nordiqc@rn.dk)
► Workshops and conferences as appropriate.
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The aim, policy, accreditation and
background of NordiQC:
See
Organization
Important dates and epitopes:
See Modules
Enrolment, participant data, and protocol form:
See Participation |
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The General module comprises three annual runs
with IHC tests for about 16 different antigens to be detected in
formalin fixed paraffin embedded tissues.
The antigenic markers
are selected to cover a spectrum of commonly used as well as selected special
or new markers.
The Breast cancer IHC module comprises
two annual runs with IHC tests for HER-2 and Estrogen receptor or Progesterone receptor
(alternating), and one other IHC marker, e.g., Ki67.
The HER-2 ISH module comprises two annual runs
with in situ hybridization (ISH) tests for HER-2 (without
immunohistochemistry). This module, active from 2012, comprise CISH/SISH test for HER-2 to be detected in formalin
fixed paraffin embedded tissues. Also FISH test is now included
(NordiQC assessment of lab scoring only). From September 2012 gastric
cancers will be included in the MTA.
Currently all pathology laboratories performing
immunohistochemistry are invited to participate
in the quality assessment of immunostains. The maximum number of
participants is 350. If this number is reached, new
applicants will be put on a waiting list.
Laboratories may apply for enrolment in the general module and/or the
breast cancer module as detailed in
Participation
(New participant).
To enrol for the first time, the laboratory must
fill out the electronic form on
www.nordiqc.org -> Participation -> New participant.
Sponsored participation must be indicated in the
Comments' field: Module, company, and time range.
The enrolled laboratory will receive a welcome message like this:
Welcome to NordiQC
Your participant number is: xxx
Your provisional password is: yyyyy
You can change your password on the website:
www.nordiqc.org/Participation.htm->
Participant data. Here you can also control, change and add data
as appropriate. At least 3 contact persons/e-mail addresses
should be indicated to ensure the communication. The
participants solely are responsible for maintaining up-to-date
e-mail addresses, accounting information (incl. purchase order
number) etc. Also check the buttons Yes or No to
each of the modules, and sponsor code, if you have obtained a
sponsorship for one or more modules. Note that all modules,
which you have marked with 'Yes', are invoiced.
The
website opens for submission of protocols for the [xx] module[s]
by [dd month]. An e-mail alert is sent. You enrol in a run by
filling out the specific protocol forms on the Participation
page, one form for each test you wish to join (the tests/markers
included are indicated on
www.nordiqc.org/modules.htm). For a given
module, protocols can only be submitted if you have ticked
Yes to the module in your Participant data. Deadline for
submission of protocols is [dd month]. Protocols must be submitted
electronically using the relevant forms on
www.nordiqc.org/Participation.htm. Protocols
sent in letters or e-mails are not accepted. An invoice based on
your selection of modules is
e-mailed. The
participant data are merged into the invoice. If no separate
payer e-mail address is indicated, the invoice is e-mailed to
contact person no. 1.
Laboratories not submitting protocols for a run and not
responding to a reminder will have their participation closed
without further notice. However, it will be opened again by
request.
Unstained slides (corresponding to the protocols
submitted) are circulated via ordinary mail to contact person
no. 1 about [dd month]. Courier mail is only used when requested
and paid by the participating lab, which in Participant data
must specify an account in a courier or logistics services
company.
General results are presented on the website and individual
results e-mailed by [dd month].
Further information can be found on www.nordiqc.org/Subscription.htm.
If you have any questions, please don't hesitate to e-mail us.
Participant data and assessment results are anonymous to all but the NordiQC
staff. However, in case of optimal results, participant data may appear on recommended
protocols, see below, unless they have requested to remain anonymous. By appointment with the laboratories, individual
assessment results may be passed on to scientific boards. Individual
results will not be given to sponsoring companies.
The laboratories enrolled are given a unique three digit
identification number, which is used for all assessments. All
participating laboratories are registered in a password protected
database. On the website, the laboratories have direct access to their own
data and are solely responsible for keeping names, e-mail addresses,
accounting information etc.
up-to-date.
By submitting protocols electronically for one or more markers
in a run announced, the enrolled laboratory
automatically is considered a participant in the scheme for the rest of the year.
Before 1 January each year, all participants get an e-mail alert inviting to continue participation in
the following year. Laboratories not submitting protocols for the first
run in the annual scheme (deadline usually about 7th January, see
modules) and not responding to a
reminder, will have their participation closed without further notice. It can be reopened by
request. Laboratories not submitting protocols for the second and third
run in the annual scheme (deadlines usually about 4th April and 12 September, resp.) and
not responding to reminders, will have their participation closed
without further notice. It
can be reopened by request.
1) Pathology
laboratories enrolled in the scheme
participate in an assessment run by staining slides circulated
from NordiQC. The laboratories can only obtain unstained slides
from NordiQC after electronic
submission of relevant
protocols before the deadline, filling out the relevant
protocol form on www.nordiqc.org -> Participation.
Protocols sent via e-mail or letter are NOT accepted. Only one protocol is
accepted for each marker/epitope. If a laboratory submits a second
protocol for the same test (e.g., because of corrections), it
automatically
overwrites the first. When protocol data are submitted, the
system gives a receipt (see figure) indicating that the data has
been successfully sent (1). Print the data (2) and keep as
documentation for your submission.

2) Only the stains listed at a particular run can be submitted
for assessment. If a laboratory does not stock an antibody
needed for the detection of an epitope, it cannot be replaced by
another antibody. This is due to the design of multitissue blocks
and the need for a large number of comparable stains in order
to make a proper assessment.
For the same reason, stains are not assessed if inappropriate
(irrelevant) antibodies have been used.
3) The
sections circulated are serial sections cut from multitissue
blocks containing several anonymized normal and tumour tissues fixed
in 10% neutral buffered formalin and embedded in paraffin.
NordiQC only sends out medical glass slides with fixed tissue. It
is certified that this material is non-hazardous, non-contagious and
non-infectious, and is of no commercial value.
For each epitope two (and only two) unstained
sections are sent
to laboratories, which have submitted protocols before the announced deadline. Together
with the slides, basic information (tissues included, deadline for submission etc.)
is provided. Unstained slides are sent at the date indicated on the
Participation page.
4) Laboratories are requested to stain the slides using their standard protocol. One (and only one) slide for
each epitope should be submitted to NordiQC for assessment together with the in-house
control slide. The other NordiQC slide should be kept in the
laboratory as a reference (or as a reserve in case of a staining
failure). In case slides are broken at the receipt,
NordiQC should be contacted by e-mail.
5) All stained
slides returned to NordiQC are assessed and marked by the assessor group.
Generally, the assessment is based on the
staining intensity and distribution in cells expected to stain,
background staining, signs of cross-reactivity, counter-staining and
tissue preservation during the staining process.
Detailed criteria are indicated on the assessment page for each
marker. The control stains are not assessed. However, they are requested in
order to interpret insufficient stains and - in the future - also to
guide the selection of controls.
6) Submitted stains (including
control stains) are stored in the NordiQC file for future
documentation. The laboratories may request the stains for review - but
they must be returned to NordiQC.
7) Examples of optimal and
suboptimal staining results are uploaded on the website as of the date
indicated on the Participation page. Among protocols giving an optimal
staining, 2-4 are presented as recommended protocols. They
are selected to reflect a spectrum of antibodies and methods and to
represent different participating laboratories. The names and e-mail
addresses of laboratories providing optimal protocols are given in the
protocols to encourage direct communication between laboratories.
If a participant providing a protocol wish to remain anonymous, this
should be specified in the Comments field. Companies will, however,
always be anonymous. Suboptimal stains are
presented anonymously with indication of possible
problems or errors in the protocols.
8) The NordiQC lab
informs all participants about their individual scores via e-mail.
In case of a borderline or poor staining result, suggestions for
protocol optimization are given. In some cases comments are given
also to good stains, e.g., in case of excessive counter-stain.
9) The laboratory should compare their
stains and protocols
with
the optimal stains
and recommended protocols published at www.nordiqc.org. A protocol recommended by NordiQC as well as
changes suggested by the assessment have to be tested carefully in
the individual laboratory before implementation into the diagnostic work.
NordiQC cannot take any responsibility for the consequences of changes
in protocols or methods in a laboratory.
10) Laboratory proficiency tests in NordiQC are
restricted to the runs. Due to limitations in staff and material it
is not possible for laboratories to obtain individual tests outside
the runs.
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Provided the use of an appropriate
antibody, each stain is marked as optimal,
good, borderline or poor.
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Optimal staining:
The staining is considered perfect or close to perfect in all of the
included tissues.
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Good staining:
The staining is considered fully acceptable in all of the included
tissues. However, the protocol may be optimized to ensure the best staining intensity and signal-to-noise ratio.
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Borderline staining:
The staining is considered
insufficient, e.g., because of a generally too weak staining or a
false negative staining of one of the included tissues, or a false
positive staining reaction. The protocol should be optimized.
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Poor staining:
The staining is considered very insufficient e.g., because of false
negative staining of several of the included tissues, or a marked
false positive staining reaction. An optimization of the protocol is
urgently needed.
Moderate or strong false positive
staining due to, e.g., endogenous biotin is not
compatible with an optimal staining.
In case of borderline or poor
marks, the laboratory may request an immediate reassessment
of the original stain, or a later reassessment based on a new stain in
a following run.
Reassessment of the
original stain:
If a participant disagrees
with borderline or poor marks given, or wishes a more elaborate
motivation, a request should be e-mailed to NordiQC. The stain will
then be reanalysed within 2-3 weeks to make sure that no error has
happened and supplementary documentation for the marks provided.
Reassessment based on
a new stain: If a participant wishes to document improvement,
e.g., after correcting an error or changing the protocol, two new unstained sections may be obtained from NordiQC for a new staining
in the following (impending) run.
However, due to the overlap between the first and second annual run
in the general module, reassessments from the first run will be
carried out in the third run.
In 2013, reassessments both from run 37 and 38 will be offered when
run 39 opens.
To obtain new unstained slides, the participant must fill out a new protocol
form before the deadline for the run in which the reassessment is
carried out.
The new slides are sent together with the slides for the next run
and the stains will be included for assessing at the assessor
meeting. Due to limited capacity, reassessment can only be carried
out once per test and only for tests included in the latest
accomplished run.
If the test is already included in the following run (e.g., HER-2),
reassessment based on a new stain cannot be requested.
The rates are unchanged from 2010, 2011,
and 2012 (however, from 2012 the Breast cancer module has been split into a Breast
cancer IHC module and a HER-2 ISH module. For participants in the Breast
cancer IHC module this means two more tests. For participants also
attending the HER-2 ISH - BRISH or FISH - test, the fee becomes DKK 700
= € 94
higher.).
Note that participation fees are based on modules, not individual tests
(but slides are only sent for markers where protocols have been
submitted).
|
Module |
Runs |
Tests |
DKK |
EUR |
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General |
3
(annual basis) |
16 |
6,900 |
926 |
| 2 (new labs after
9th Jan.) |
10 |
4,900 |
658 |
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1 (new labs after
9th
Apr.) |
5 |
2,900 |
390 |
|
Breast cancer IHC |
2
(annual basis) |
6 |
2,900 |
390 |
| 1 (new labs after 13th Apr.) |
3 |
1,900
|
255 |
| General and Breast cancer
IHC |
5 |
22 |
*9,300 |
*1,248 |
HER-2 ISH
in combination with any
other module |
2
(annual basis only) |
2 |
700 |
94 |
HER-2 ISH
without combination with
another module |
2
(annual basis only) |
2 |
1,400 |
188 |
*
Reduced fee for labs participating on an annual basis in
both modules and invoiced in January.
Both modules must be ticked Yes in Participant data. |
NordiQC is a non-profit organization, and the rates
indicated in the table are meeting the expenses only, wherefore discount is
not available. Laboratories with financial difficulties are encouraged
to contact, e.g., a local diagnostics vendor or distributor for
sponsorship (see Sponsored participation below). Apart from new participants, laboratories can
only participate on an annual basis paying the fee indicated above (i.e., the fee is not reduced if a
laboratory does not stock an antibody or omits to submit protocols or
return slides).
Invoicing
Laboratories are invoiced when unstained slides are circulated by
NordiQC in the first run of the year.
If an e-mail address for invoice is indicated in Participant data (Accounting
information), an invoice is sent electronically to this address, as well
as contact person no. 1.
If no such address is indicated, the invoice will be e-mailed to contact person no.
1.
Deadline for payment is indicated in the invoice. Payment is indicated
in EUR and DKK. However, any convertible currency is accepted. Fee is
non-refundable.
If the amount is not paid by deadline, an electronic reminder will
be sent to all the e-mail addresses indicated.
Laboratories neither paying the fee invoiced nor
responding to a reminder will have their participation closed until the
account is settled.
Sponsored
participation
If a participating laboratory obtain a sponsorship from
a company or distributor in order to participate for free in NordiQC (General module
and/or Breast cancer module), the sponsor code (provided by the sponsor
or NordiQC) must be indicated in the Participant data. If a sponsor code
is unavailable, the lab must e-mail sponsor data (including sponsor
e-mail address) to NordiQC in order to obtain a sponsor code.
After circulation of the unstained slides, an invoice
is sent electronically to the sponsor e-mail address associated with the
sponsor code.
Individual assessment results will not be sent to the sponsor, unless a
specific agreement has been
made.
Bank address:
Danske Bank Aalborg
Afdeling
Algade 53
Postboks 1264
DK-9000 Aalborg
Registration number
3201, account number
34 02 55 20 26.
Participants outside
Denmark may use the the International Bank Account
Number (IBAN) and Society for Worldwide Interbank
Financial Telecommunication (SWIFT) / Bank Identifier
Code (BIC):
IBAN number: DK 32 30 00 34 02 55 20 26
SWIFT-BIC code: DABADKKK
Mark the payment
with your three digit participant number (NQC…)
and research account
88.38 NordiQC
4202HK.
Cheques
should be made payable to: NordiQC, Aalborg Hospital quoting the
above invoice number and forward to:
NordiQC
Institute of Pathology
Aalborg Hospital
Ladegaardsgade 3
DK-9000
Aalborg
Denmark
Credit cards can unfortunately not be accepted by
NordiQC.
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Region Nordjylland (Aalborg Hospital) SE number = VAT
number = CVR no.: 29 19 09 41
Aalborg Hospital EAN* number for invoices:
57 98 00 32 81 179 (for wares: 57 98 00 32 81 216)
*EAN: European Article
Numbering, the number is an electronic location number
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Contracts with Laboratory for Immunohistochemistry and
Development
Institute of Pathology, Aalborg Hospital
Banking details as above
Mark the payment: research account
88.39 IHCU 4202HK.
Almost all participants obtain and return the
slides by ordinary mail.
The risk of loss is generally very little. In case a lab repeatedly do
not receive their unstained slides, or only get them very late,
submission of slides in worldwide parcels with
courier or logistics services companies like FedEx or DHL may be
needed.
The expenses must be paid by the
participant. NordiQC only send slides via courier service provided
that the laboratory has an account in such a company and indicate
the account number in their Participant data (Comments' field).
Street
address for courier mail (air waybill):
NordiQC
Institute of Pathology
Aalborg Hospital
Ladegaardsgade 3
DK-9000
Aalborg
Denmark
Tel.: +45 9932 1620 (courier mail only!)
Fax: +45 9811 5990
Do not write P.O.Box on
courier mail.
Sponsorships for NordiQC scientific projects from organisations, producers, vendors and distributors affiliated
immunohistochemistry are welcome (as for
sponsored participation for individual laboratories, see
above).
Sponsorships support the scientific work but have no influence on the
NordiQC methods, results or conclusions.
The annual
NordiQC sponsorship fee is DKK 12,000 (€ 1610). Sponsors may have their logo
or advertisement placed on the frontpage (max 120 x max 32 pixels) with link to their own website.
Sponsorship including annual participation for one
laboratory (one or more modules) is DKK 18,000
(€2415) annually, for two laboratories DKK 24,000 (€ 3220).
Payment for sponsorships should be forwarded to
the
account in Danske Bank (see address
above).
Mark the payment: research account
59.05 NordiQC 4202HK.
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