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.

The enrolled laboratory will receive a welcome message like this:

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.
 

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.
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.

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 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.

Subscription rates 2013

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).
 

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.
   

Banking details

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.
 

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.

Courier mail

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

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.