Subscription

Schemes

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.
 

Enrolment

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.

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 participates in the scheme for the rest of the year.

By 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 15 January) and not responding to a reminder, will have their participation closed. It can be reopened by request. Laboratories not submitting protocols for the second and third run in the annual scheme (deadlines 15 May and 15 September, resp.) and not responding to reminders, will have their participation closed. It can be reopened by request.
 

Assessment method

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. 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.

Marks

● Provided the use of an appropriate antibody, each stain is marked as optimal, good, borderline or poor.

• Optimal staining: The staining is considered perfect or close to perfect in all of the included tissues.

• 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.

• 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.

• 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.

Reassessment

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 the 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. To obtain new unstained slides, the participant must fill out a new protocol form before the deadline for the next run.
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.

Subscription rates 2012

The rates are basically unchanged from 2010 and 2011, but 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 gives two more tests. For participants that also attend the HER-2 ISH (BRISH/FISH) test, the fee becomes DKK 700 (€ 94) higher.
 

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 a payer e-mail address is indicated in Participant data (Accounting information), an invoice is sent electronically to this address. If no payer e-mail address is indicated, the invoice will be e-mailed to contact person no. 1.
Deadline for payment is indicated in the invoice. 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 fee has been paid.

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 data must be indicated in the Accounting information fields of the Participant data. If a payer e-mail address is indicated in Participant data, an invoice is sent electronically to this address after circulation of the unstained slides. If no payer e-mail address is indicated, the invoice is e-mailed to Contact person no. 1, who must forward the invoice to the sponsor. Reduced fee is not available.
Individual assessment results will not be sent to the sponsor, unless a specific agreement has been made.
   

Banking details

After 1st July 2011:

Bank address:

Danske Bank

Aalborg Afdeling
Algade 53

Postboks 1264
DK-9000 Aalborg
 

For participants outside Denmark:

The payment should be forwarded to

SWIFT-BIC code: DABADKKK

IBAN number: DK 32 30 00 34 02 55 20 26

Mark the payment with your three digit participant number (NQC…)

and research account 88.38 NordiQC 4202HK.

For Danish participants:

Reg. no. 3201, account no. 34 02 55 20 26

Mark the payment with your three digit participant number (NQC…)

and research account 88.38 NordiQC 4202HK.

Previous Bank address - not valid after 1st July 2011.

Spar Nord Bank, Skelagervej 15, P.O.Box 162, DK-9100 Aalborg

SWIFT-BIC code: SPNODK22

IBAN number: DK9090354570146810
 

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.
 

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.

Air waybills

Almost all participants return the slides the same way as they are forwarded, i.e., by ordinary mail.
The risk of loss is generally very little. Circulation of slides in worldwide parcels via air waybill with logistics services companies like FedEx or DHL may be needed on special occasions. The expenses must be paid by the participant.

Street address for air waybill:

NordiQC
Institute of Pathology

Aalborg Hospital

Ladegaardsgade 3

DK-9000 Aalborg
Denmark

Tel.: +45 9932 1620 (waybill only!)

Fax: +45 9811 5990

Do not write P.O.Box on waybills.

Sponsorships

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 (general module and breast cancer module) is DKK 18,000 (€2415) annually.

Payment for sponsorships should be forwarded to the account in Danske Bank (see address above).

Mark the payment: research account 59.05 NordiQC 4202HK.