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Aim
of NordiQC
The aim of
Nordic immunohistochemical Quality Control (NordiQC) is to promote the quality
of immunohistochemistry and expand its clinical use by arranging schemes for
immunohistochemical staining and providing examples of good protocols
and other information including descriptions of epitopes and technical
solutions.
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Scheme advisor
Emina Torlakovic,
Saskatoon, SK, Canada
Technician
Lise Emanuelsen,
Aalborg, Denmark
(e-mail: le@rn.dk)
Assessors 2013
General
module
Jan Klos,
Stavanger, NO
Søren Nielsen,
Aalborg, DK
Ari Ristimäki, Helsinki,
FI
Viktoria Gaspar, Helsingborg, SE
Mogens Vyberg, Aalborg, DK
Michael Bzorek,
Næstved, DK
Ole Nielsen,
Odense, DK
Rasmus Røge,
Aalborg, DK
Breast
cancer IHC module
Gunilla Chebil,
Helsingborg, SE
Viktoria Gaspar, Helsingborg, SE
Vibeke Jensen, Aarhus, DK
Päivi
Heikkilä,
Helsinki, FI
Jan Bak,
Stavanger,
NO
Søren Nielsen,
Aalborg, DK
Rasmus Røge,
Aalborg, DK
HER2 ISH
Module
Anne-Vibeke Lænkholm, Copenhagen, DK
Ole Nielsen,
Odense, DK
Søren Nielsen,
Aalborg, DK |
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Accreditation
Aalborg University Hospital is accredited
according to The Danish Healthcare Quality Programme, see the
certificate and the website
http://www.ikas.dk/IKAS/English.aspx. Separate accreditation of
NordiQC is currently not possible.
As NordiQC receives numerous "vendor"
questionnaires and are asked to fill out various forms answering questions that
are mostly irrelevant for the our service, we do not have the capacity to answer
them individually.
The most common questions and answers
are given here (get the text as pdf):
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Participants' questions |
NordiQC's answers |
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Vendor
Name |
Nordic
Immunohistochemical Quality Control (NordiQC) |
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Address: |
Institute of Pathology, Aalborg University Hospital, P.O.Box 561,
DK-9100 Aalborg |
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Supplies/ Services Provided |
External
quality assessments for immunohistochemistry in human histopathology |
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Is your
Company currently accredited to a recognised Quality Management System?
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No |
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If no,
is your Company actively seeking or does it intend to seek accreditation
in the future? |
Accreditation of Aalborg University Hospital hosting NordiQC is
planned in 2015. |
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If your
Company is not accredited to a recognised Quality Management
System, please provide information on how you control the following: |
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Stock
Control (including ordering, receipt and rotation) |
Not
relevant |
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Stock
Checks with regard to expiry dates before despatch to customers |
Not
relevant |
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Quality
Control procedures undertaken by your company on receipt of material
from the manufacturer |
Not
relevant |
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Storage
and transport facilities including temperature monitoring and mapping
for temperature dependent materials |
Not
relevant |
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Would
permission be given to perform an on-site audit of your company |
Yes |
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Is it
your policy to provide Certificates of Analysis/ Certificates of
Conformance? |
Yes |
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If yes,
do you provide same routinely or on request: |
Routinely |
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Please
describe your policy for informing customers of changes in advance of
implementation as it applies to diagnostic reagents/ kits, software
upgrade etc.: |
Not
relevant |
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How do
you ensure that the diagnostic reagents/ kits that you supply are in
accordance with the EU directive in relation to CE marking of invitro
diagnostic devices: |
Not
relevant |
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Describe
your policy on following up customer complaints: |
Not
relevant. For reassessments, see
http://www.nordiqc.org/Subscription.htm#Reassessment |
NordiQC 2012
Mogens Vyberg
Director
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NordiQC's background
The diagnostic
potential of immunohistochemistry (IHC) in pathology is universally accepted,
but its reliability is compromised by lack of standardisation and poor
performance. The principal advantage of external quality assessment (EQA) is the
ability to detect differences of quality between laboratories and provide
guidance on how to achieve acceptable standards. In the Nordic countries, some
pathology laboratories have participated in UK-NEQAS schemes, and some in
regional schemes. Still, there is a huge need for
improvements and for communication in the field of immunohistochemistry
particularly due to considerable variations in standards and routines among
laboratories and the fact that several laboratories have not had the time or
opportunities to develop their immunohistochemical panels and procedures. The
increasing number of useful antibodies and protocols have also led to confusion
or even resignation among some of our colleagues.
In 1999 nine
pathologists from Denmark, Finland, Norway and Sweden with initial help from Dako constructed a Nordic pilot scheme for EQA.
A number of test runs were performed involving a number of
laboratories increasing from four to 55. Based on this experience,
NordiQC was established as a permanent organisation from January 2003
with Institute of Pathology, Aalborg University Hospital as its domicile.
A core group was
performed with one representative from each of the four Nordic countries -
Denmark: Mogens Vyberg, Aalborg; Norway: Emina Torlakovic, Oslo; Sweden: Tomas
Seidal, Karlstad (later Halmstad) and Finland: Heikki Helin, Tampere (later
Helsinki). Because of a new position in Canada, Emina Torlakovic left the core
group by the end of 2003 to be replaced by Bjørn Risberg, Oslo, and from 2009 Jan
Klos, Stavanger, took over as the Norwegian representative. Tomas Seidal left
the core group in 2012, Viktoria Gaspar, Lund, took over as the Swedish
representative.
In the first scheme
(2003), about 70
Nordic laboratories participated. In 2012, more than
350 laboratories from about 40 countries have attended.
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