TOPICS IN THIS ISSUE

 

The Continuation of EQAnews in the New Millenium……........................................151

Thanking Adam Uldall for his work with EQAnews………........................................152

New Publications from WHO.......................................................................................152

Quality Evolution on Performance of Medical Laboratories in Parasitology:

Blood Parasitology and Toxoplasmosis....................................................................153

The EQAnews Webpage…........................................................................................154

News from the IFCC/EMD/Committee on Analytical Quality...................................155

ABNT/CB-36: Brazilian Committee of Clinical Analyses and In Vitro Diagnostics...................................................................................................................158

MERCOSUR Normalization Project...........................................................................158

 

THE CONTINUATION OF EQAnews IN THE NEW MILLENIUM


Not that it has much to do with the entry to a new millenium but, a partially new team has taken over the challenge of continuing EQAnews. The chairman of EQALM Dr. J.C. Libeer is thanking the creator and former Editor Dr. Adam Uldall for his work with EQAnews elsewhere in this issue.

The new production team has no immediate plans to change the content or appearance of this journal. On the other hand we will always be working on continous development and growth in order to keep EQAnews in business as a most valuable tool for communication between organizers of External Quality Assurance. We  will strongly encourage everybody working in the area of EQA to publish their findings in this journal. The co-editors will from time to time be publishing specific subjects or overviews of EQA in the different disciplines of laboratory medicine.

The articles, notes etc. submitted for publication in EQAnews are not subjected to referees. Rather they are commented on by a co-editor experienced in the particular field and the comments are forwarded to the author for evaluation. This way articles can be made ready for publication in weeks and EQAnews can publish the very latest news. For details on how and when to send in material for EQAnews please consult the inside of the back cover.

Details on how to subscribe, advertise etc. will be given in the next issue.

 

THANKING ADAM ULDALL FOR HIS WORK WITH EQAnews

Dr. Pharm. J.C. Libeer, EQALM Chairman

 At a meeting of 23 European EQAS organizers, on December 19th 1989 in Brussels, a proposal for an EQAnews sheet was agreed upon. The first issue appeared in January 1990. For ten years, Adam Uldall has been the Editor and promotor of EQAnews. We cannot estimate how many kilogram of EQAnews issues Adam has transported all over the world, from Argentina to China. But we know how much effort it took to fill each issue. During all these years EQAnews has given information to EQAS organizers that was not found in other publications. The compendium on advanced external quality assurance in clinical biochemistry, issued as the EQAnews February 2000 number was published as the crown of his editorship. When Adam decided to resign this editorship, we were happy that he found a new editor in the person of Peter Mogensen. We wish all good luck to Peter. I take here also the opportunity to invite our readers to share their experiences and to contribute in EQAnews. Litterature data on EQAS organisational aspects are scarce. As EQAS organizers we can learn a lot from each others. Adam Uldall will continue to be active in DEKS.

Thank you for all this work Adam, you did a wonderfull job!


NEW PUBLICATIONS FROM THE WORLD HEALTH ORGANIZATION

Dr. Andre Deom

The World Health Organization (WHO) has recently issued 2 publications of interest for EQA. Both are in english only. WHO/ DIL/LAB/99.1 deals with the use of anticoagulants in diagnostic laboratory investigations. Advantages and disadvantages of using plasma, serum, or other analytical samples are discussed. It is imperative that the in- vitro state of the quantity in the body fluid be preserved unchanged to justify a medically valid conclusion. WHO/DIL/LAB/99.2 deals with the reqirements and guidance for EQAS for health laboratories prepared by a group of experts. The intention is to offer to potential EQA organizing centres information on how to start or to prepare QC samples.



QUALITY EVOLUTION ON PERFORMANCE OF MEDICAL LABORATORIES IN PARASITOLOGY: BLOOD PARASITOLOGY AND TOXOPLASMOSIS

1A. Mauris, 1A. Deom, 1P-A Morandi, 2H. Marti, 2J. Zufferey.

1Swiss Quality Control Centre, Geneva. 2Swiss Tropical Institute, Basel. 3Microbiology Institute, CHUV, Lausanne. Switzerland.

Dr. A. Deom, CSCQ c/o HUG, 2 Chemin du Petit Bel-Air, CH-1225 CHENE-BOURG, Switzerland. E-mail: cscq.admin@hcuge.ch, www.smis.ch/cscq

 

The Swiss Quality Control Centre (CSCQ) is a non-profit organisation. It offers surveys for medical analysis to laboratories or entities that are interested.

Since 1997, the CSCQ has organised an external quality assessment scheme (EQAS) for blood parasitology and, since 1999, one for toxoplasmosis serology. The survey materials consist of the shipment of smears and sera to participants. A brief anamnesis or clinical history is delivered with the samples. After receiving the results, the CSCQ prepares a survey report which includes the expected results, the results obtained by the participants, the acceptable values and the advice of an external expert. Private and hospital laboratories as well as doctor’s offices participate in this EQA. The CSCQ guarantees the strict confidentiality of the identity and results of each participant.

 

Blood parasitology

Preparation of quality assessment slides: these were prepared in a recognised and well known Institute, specialising in parasitology. Thin blood films were quickly prepared and stained from blood collected from the same donor. The colouration or staining technique was the Giemsa pH 7,2 as recommended by the World Health Organisation (WHO). Parasitemia was measured by looking at 1,000 red blood cells and the results were given in % or ‰ of infected red blood cells.

The number of participants currently amounts to 50 and the average survey participation is 76%. Except for two positive slides with Loa loa, every slide was positive with P. falciparum, vivax, or malariae. The quality of the results was very dependent on the parasitemia. In fact, when the latter was low (< 1‰ of infected red blood cells), more than 70% of the participants gave a wrong interpretation. The increase in the number of parasites corresponded to a better interpretation. For example, all participants correctly identified the parasite in a survey with a slide containing 14% of P. falciparum parasites. The identification of the species remained a problem. Nearly 15% of the participants identified two or three species of parasites on the slide, when only one species was present on the slides sent so far. The results obtained after two consecutive surveys with exactly the same type of slide did not show any improvement, despite comments and suggestions attached to the first report. Many participants found it difficult to identify P. falciparum in a thick drop (12% of correct results).

43% of the results were correct when participants examined a slide with a Loa loa microfilariae (3-4 microfilariae per slide)., 30% found microfilariae species and 6% gave a negative result. Nearly 15% of the participants incorrectly found different species of plasmodium

 

Toxoplasmosis

The first survey held in April 1999 included 41 participants among whom 93% returned the form. The quality of IgG and IgM measures proved excellent and the requested interpretation and comments were satisfactory.

 

Conclusions

The results suggest that, in order to improve the work in each laboratory, it is recommended that the participants 1) follow a regular training, 2) pay attention to the quality of the material examined, 3) maintain their microscope and 4) work with reference blood-smears.


THE EQAnews WEBPAGE

Dr. Jonathan Middle

UK NEQAS has been delighted to host the EQALM and EQAnews web pages for a number of years. UK NEQAS member schemes are enthusiastic supporters of EQALM and occasional contributors to EQAnews. The page (found at http:// www. ukneqas.org.uk/eqanews.html and .../eqalm.html) are maintained by the webmaster Dr. Jonathan Middle (currently Chairman of the UK NEQAS Executive Committee). Comments on the current pages would be greatfully received). The EQAnews web page is intended just to supply basic contact information and a list of topics for each issue. Links to other organisations are provided where appropriate.

NEWS FROM THE IFCC/EMD/COMMITTEE ON ANALYTICAL QUALITY

Daniel Mazziotta, Chairman of IFCC/EMD/C-AQ, MACROBUTTON

HtmlResAnchor dmpeec@netverk.com.ar, Fax: +54-221-4232021

 

The last meeting of the IFCC/ EMD/C-AQ was held in Hanover, December 11/12, 1999. Participating in the meeting were the following: Daniella Harell, IL; Jean-Claude Libeer, BE; Gerhard Schumann, DE; Adam Uldall (on behalf of IRMM), DK; Daniel Mazziotta (chair), AR.

 

Serum Donation Project (SDP)

A final draft report of the first distribution of control material donated by Bayer Corporation for the IFCC/EMD/C-AQ was presented. The report will be published in the JIFCC. After discussion of the report it was concluded to prepare a form to be sent to organizers involved in the execution of the project in order to assess the impact of the project.

SDP in India

The SDP in India is ready to start. Dr. Kanagasabapathy from  Vellore, India, is responsible for the coordination of  the plan pre-viously established by the C-AQ to which India agreed. Prof. Wielan Höelzel communicated that Roche Diagnostics had kindly donated the control materials needed for the execution of this project.

SDP in Iran

Formal requirements for obtaining permission to export quality control serum to Iran have postponed this donation project, but Dr. Adam Uldall has now obtained all the needed permissions. 1760 10 ml vials of lyophilised animal control serum will be dispatched in early May 2000. The serum was kindly donated by Nycomed Denmark A/S, Diagnostics, P.O. Box 321, DK-4000 Roskilde, Denmark.

Course on Organization and Management of EQAS.

This course was first organized by the EQAS of  the Argentine Biochemical Foundation in 1996 and is given each two years. Organizers of the countries who receive the first Serum Donation Project (SDP) of the IFCC/EMD/ C-AQ were trained and the program of that course was included in the draft of the report of the SDP was discussed.  It highlighted the importance of this type of course in training human resources for establishing EQAS.  JCL suggest the expansion of the program and he sent a list of items to be included, mainly dealing with quality management for the scheme (Procedure manual for EQA).

 Course on preparation of control materials.

In many cases, control materials from industry are very expensive for certain EQAS that are trying to establish themselves in developing countries. This inhibits from becoming regular schemes, those EQAS that the Serum Donation Project promotes. The rational behind this course is to select certain types of control materials that could be relatively easy to prepare and at the same time expand the scope of those primarily schemes. In this sense, the following fields are mentioned as possible candidates to work on: hematology, bacteriology, parasitology and instrumental control. Several proposed materials for different specialties were mentioned during the discussion of the topic: Hematology (Fixed blood smears to be stained by participants, hemoglobin lysates with and without pseudoleucocytes, photographs of blood smears and reticulocytes.); Parasitology (use of spores of Lycopodium clavatum for assessing parasites size determination, mix up of parasites eggs with brown beans to produce feces like material, preparation of concentrates of parasites eggs or other parasitic forms to dilute it and distribute aliquots of that dilution for parasite identification.)

Bacteriology (Standard strain in soft agar.); Instrumental control (use of reagents to evaluate the accuracy of wavelength by means of isosbestic point determination, absorbance accuracy and linearity in the UV and VIS region and stray light for spectrophotometers.)
This is important in regions were refurbished equipment is common. It is suggested that the manufacturing companies of automatic equipment should develop protocols to run appropriate controls and also that this knowledge should be published in the home page of the IFCC.


Network of Reference Laboratories for Enzyme Measurement
A report of the results of the pilot studies between Germany and Argentina was finished. The reference laboratory in Argentina has established  target values for ALT and AST at 30 ºC and 37 ºC for control materials distributed in their EQAS. The initial study was done with the same lot of reagents, calibrators and controls donated generously by Roche Diagnostics to both laboratories. The secondary  metrological level should be automatic determination with calibration. This is the level were the net of reference laboratories should be expanded. It is highlighted the importance of developing point of access to traceability in several regions of the world.

 

IRMM-IMEP-17
The C-AQ agree with the main objectives of the IMEP project of promoting the concepts of reference materials and traceability. The EMD/C-AQ highlighted the educational aspects of the project. In line with this idea, the C-AQ believes that the project must consider laboratories from many regions of the world as possible.  One point to be considered in order to involve laboratories from many regions of the world is related to the type of materials to be sent. Frozen materials lead to the problem maintaining the frozen state until arrival at the laboratory. The local distribution, in several regions  could be a serious problem due to a) good cold chain and b) expense. The use of lyophilized materials was proposed by the C-AQ instead of frozen materials, provided in 10 ml vials to reduce uncertainty of reconstitution and at the same time enough control material is given to the laboratory. Economics and practical aspects were mention to support this idea. The use of lyophilized material could be done together with frozen materials (when applicable) and will allow the participation of laboratories of many regions which, otherwise could not participate. The lower quality of lyophilized materials compared to frozen ones needs to be balanced with the educational impact at world wide level.

 

Fundamentals in Internet

It is reported that the electronic version of Fundamentals of External Quality Assessment (as PDF file) was published in the home page of IFCC in the What's New section.

Regarding the revision and update of this publication (originally published in 1996) it was decided to investigate the degree of interest the document has, measuring the frequency of downloading. Technical Secretariat will be asked how to get that information.

 

Software for managing and data handling of EQAS.

It is  reported that the international version of the software produced by the Argentine Biochemical Foundation is working very well in Paraguay, Uruguay, Dominican Republic, Chile, Bolivia, and Guatemala. The software is being tested for a small scheme for TDM in Denmark. An update fixing the Y2K problem was developed. Non parametric data treatment will be included in the menu of the software in the future. JCL mention that in the home page of the Belgium EQAS a document on non parametric data treatment is published.

For any question or comments please contact Dr. Daniel Mazziotta at the above adress.


ABNT/CB-36: Brazilian Committee of Clinical Analyses and In Vitro Diagnostics.

Technical Secretariat: Socidade Brasileira de Análises Clínicas

 

Norms projects

36:004.04-001 Glossary of terms to be used in the Clinical Laboratory and In Vitro Diagnostics

This glossary is appointed to  be used in the Clinical Laboratories and by manufacturers of In Vitro diagnostics. The aim is to  furnish an adequate nomenclature of the most frequent terms, define it and harmonize the terminology used and required by the activities in this sectors.

 

36:001.01-001 Quality Management in the Clinical Laboratory

This Brazilian norm is intended to establish the requirements for Quality Management in the Clinical Laboratory. Its content includes the realization of tests, developing or set up of new methods as well as to offer guidance on quality procedures in order to guarantee the reliability of test performed by the Clinical Laboratories.


MERCOSUR Normalization Committee.

MERCOSUR Sectional Committee -CSM 20

The CSM-20, Sectional Committee of Clinical Analyses and In Vitro Diagnostics began its activities aiming to sector normalization. Those interested in participating must contact with Technical Secretariat of CSM-20, Sociedade Brasileira de Analises Clinicas at www.sbac.org.br.

 

INFORMATION ABOUT EQAnews 2000

Generel

EQAnews communicates information about quality assurance in the medical laboratory: Clinical Biochemistry, Clinical Immunology, Clinical Microbiology, Clinical Parasitology, Clinical Virology, Haematology, Hemostasis etc.

EQAnews is issued four times per year, February, May, September and December on behalf of EQALM. For scope see EQAnews 1997; 8 no. 4 p. 71-72.

 

Supervisors of EQAnews

Dr. Daniel Mazziotta

chair of the C-AQ of EMD/IFCC

Programa de Evaluacion Externa de Calidad (PEEC) Fundacion Bioquimica

Calle 6 No. 1344, 1900 La Plata

Republica Argentina

Fax: +54 2 2142 32021

E-mail: dmpeec@netwerk.com.ar

 

Dr. J.C. Libeer

chair of EQALM

Scientific Institute of Public Health, Clinical Biology Dep.

J. Wytmanstraat 14

B-1050, Brussels

Belgium

Fax: +32 2642 5645

E-mail:

jean-claude.libeer@iph.fgov.be

 

 

Manuscripts

The material provided should not be more than two double spaced A4 pages, approx. 800 words, including tables and figures. Manuscripts should be received no later than the first working day of the month prior to the month of issuing EQAnews. The manuscript should preferably be provided in an electronic medium.

 

Editorials

Communications in EQAnews which carry no identification of authorship are written by the editor.

 

Correspondance with EQAnews

All correspondance to EQAnews should be send to the editor:

Peter K. Mogensen

Statens Serum Institut

Artillerivej 5

DK-2300  Copenhagen S

Fax: +45 32 68 31 45

E-mail: pkm@ssi.dk

From 01.06.2000: pkm@novo.dk

The editor takes no legal or financial responsibility for errors or misinformation which may occur in EQAnews.

© 2000 by EQALM and IFCC.