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 module comprises two annual runs with IHC tests for HER-2 and Estrogen receptor or Progesterone receptor (alternating), and CISH/SISH test for HER-2 to be detected in formalin fixed paraffin embedded tissues. FISH test is not included.
 

Enrolment

Currently all pathology laboratories performing immunohistochemistry are invited to participate in the quality assessment of immunostains. Nordic laboratories have first claim. In case the number of applicant exceeds 250, new laboratories will be put on a waiting list. However, we expect that the capacity can be expanded during 2010.

Participants 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. By appointment with the laboratories, individual assessment results may be passed on to scientific boards.

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 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 year concerned. 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

● 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 form on www.nordiqc.org -> Participation. Protocols sent via e-mail or letter are NOT accepted. Only one protocol is accepted for each epitope. If a laboratory submits a second protocol for a given epitope (e.g., because of corrections), it automatically overwrites the first.

● 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.

● 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.

● 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.

● 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.

● 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.

● 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. These 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.

● 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.

● 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.

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 run. To obtain new unstained slides, the participant must fill out a new protocol form before the deadline for the next run. In the form, select "Other epitope by appointment", specify the epitope, fill in protocol data, and write "Reassessment' in the Comments field.
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. 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
 

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 vendor or distributor of antibodies for sponsorship (see below). Apart from new participants, laboratories can only participate on an annual basis (i.e., the fee is not reduced if a laboratory temporarily omits submitting protocols or 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, an invoice is sent electronically to this address with an e-mail copy to the 1st contact person. If no payer e-mail address is indicated, a printed invoice is enclosed with the slides circulated to the 1st contact person, who must forward the invoice to the hospital accounting department.
Deadline for payment is indicated in the invoice. Fee is non-refundable. If the amount is not paid before 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 is paid.

Sponsored participation
If a participant obtain a sponsorship from a company to be able to participate for free in NordiQC (General module and/or Breast cancer module), the name of the sponsor and the sponsored period must be indicated in Participant data (Comments' field). If a payer e-mail address is indicated in Participant data, an invoice is sent electronically to this address with an e-mail copy to the 1st contact person. If no payer e-mail address is indicated, the invoice is enclosed with the year's first set of slides circulated to the 1st contact person, 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.
Individual assessment results may be sent to a scientific board, if the board has got acceptance from the participants.
   

Banking details

Bank address:

Spar Nord Bank

Skelagervej 15

P.O.Box 162

DK-9100 Aalborg

For participants outside Denmark:

The payment should be forwarded to

SWIFT-BIC code: SPNODK22

IBAN number: DK 90 90 35 45 70 14 68 10

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

and research account 88.38 NordiQC 4202HK.

For Danish participants:

Reg. no. 9035, account no. 45 70 14 68 10

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

Bank address:

Spar Nord Bank

Skelagervej 15

P.O.Box 162

DK-9100 Aalborg
Denmark

For contractors outside Denmark:

The payment should be forwarded to

SWIFT-BIC code: SPNODK22

IBAN number: DK 90 90 35 45 70 14 68 10

 

Mark the payment: research account 88.39 IHCU 4202HK.

For Danish contractors:

Reg. no. 9035, account no. 45 70 14 68 10

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!)

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 account in Spar Nord Bank (see address above):

For sponsors outside Denmark:

SWIFT-BIC code: SPNODK22

IBAN number: DK 90 90 35 45 70 14 68 10

Mark the payment: research account 59.05 NordiQC 4202HK.

For Danish sponsors:

Reg. no. 9035, account no. 45 70 14 68 10

Mark the payment: research account 59.05 NordiQC 4202HK.