Safety in Anatomical Laboratory

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Safety in Histo Lab

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A new issue of CCLM is available online! Vol 54, Issue 7 (June 2016)

Dear All,

Following the agreement on mutual cooperation between EFLM and W. de Gruyter for Clinical Chemistry and Laboratory Medicine journal (CCLM), it has been planned to send regularly to the EFLM contacts the table of contents of CCLM issues and the list of future titles as well. I do hope you will appreciate the initiative which is intended as a further service by EFLM to our European professional community.  CCLM is published on a monthly basis and is the most relevant Journal on Clinical Chemistry in Europe; it is a valuable and updated source of knowledge for the professionals in the field, well recognized all over the world.  The CCLM 2014 Impact factor is 2.707.

With kindest regards,
MariaStella Graziani
Chair EFLM Communication Committee

A new issue of ‘Clinical Chemistry and Laboratory Medicine (CCLM)’ is available online from De Gruyter Online – Click on the following links to view the new contents:

In Memoriam: Gérard Siest (1936–2016)
Plebani, Mario / Jahnke, Heike

Improving diagnosis and reducing diagnostic errors: the next frontier of laboratory medicine
Plebani, Mario / Lippi, Giuseppe

The quality indicator paradox
Plebani, Mario

Clinical utility of the (-2)proPSA and evaluation of the evidence: a systematic review
Pecoraro, Valentina / Roli, Laura / Plebani, Mario / Trenti, Tommaso

Why are clinical practice guidelines not followed?
Barth, Julian / Misra, Shivani / Aakre, Kristin Moberg / Langlois, Michel R. / Watine, Joseph / Twomey, Patrick J.

Patient identification and tube labelling – a call for harmonisation
van Dongen-Lases, Edmée C. / Cornes, Michael P. / Grankvist, Kjell / Ibarz, Mercedes / Kristensen, Gunn B.B. / Lippi, Giuseppe / Nybo, Mads / Simundic, Ana-Maria / on behalf of the Working Group for Preanalytical Phase (WG-PRE), European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

A fast and simple method for detecting and quantifying donor-derived cell-free DNA in sera of solid organ transplant recipients as a biomarker for graft function
Adamek, Martina / Opelz, Gerhard / Klein, Katrin / Morath, Christian / Tran, Thuong Hien

Performance of two commercially available BCR-ABL1 quantification assays that use an international reporting scale
Seo, Soo Hyun / Lee, Seung Jun / Park, Seungman / Kim, Min Jin / Song, Ji Yoon / Ra, Eun Kyung / Cho, Sung Im / Kim, Hyun Kyung / Yang, Man Gil / Kim, Ji Yeon / Park, Sung Sup / Seong, Moon-Woo

HAND1 loss-of-function mutation associated with familial dilated cardiomyopathy
Zhou, Yi-Meng / Dai, Xiao-Yong / Qiu, Xing-Biao / Yuan, Fang / Li, Ruo-Gu / Xu, Ying-Jia / Qu, Xin-Kai / Huang, Ri-Tai / Xue, Song / Yang, Yi-Qing

Performance criteria and quality indicators for the post-analytical phase
Sciacovelli, Laura / Aita, Ada / Padoan, Andrea / Pelloso, Michela / Antonelli, Giorgia / Piva, Elisa / Chiozza, Maria Laura / Plebani, Mario

Assessing the commutability of reference material formats for the harmonization of amyloid-β measurements
Bjerke, Maria / Andreasson, Ulf / Kuhlmann, Julia / Portelius, Erik / Pannee, Josef / Lewczuk, Piotr / Umek, Robert M. / Vanmechelen, Eugeen / Vanderstichele, Hugo / Stoops, Erik / Lewis, Jennifer / Vandijck, Manu / Kostanjevecki, Vesna / Jeromin, Andreas / Salamone, Salvatore J. / Schmidt, Oliver / Matzen, Anja / Madin, Kairat / Eichenlaub, Udo / Bittner, Tobias / Shaw, Leslie M. / Zegers, Ingrid / Zetterberg, Henrik / Blennow, Kaj

Quantitative determination of four immunosuppressants by high resolution mass spectrometry (HRMS)
Bruns, Kai / Mönnikes, Rene / Lackner, Karl J.

Measurement of plasma vitamin K1 (phylloquinone) and K2 (menaquinones-4 and -7) using HPLC-tandem mass spectrometry
Riphagen, Ineke J. / van der Molen, Jan C. / van Faassen, Martijn / Navis, Gerjan / de Borst, Martin H. / Muskiet, Frits A.J. / de Jong, Wilhelmina H.A. / Bakker, Stephan J.L. / Kema, Ido P.

Therapeutic drug monitoring of infliximab: performance evaluation of three commercial ELISA kits
Schmitz, Ellen M.H. / van de Kerkhof, Daan / Hamann, Dörte / van Dongen, Joost L.J. / Kuijper, Philip H.M. / Brunsveld, Luc / Scharnhorst, Volkher / Broeren, Maarten A.C.

High level of oxysterols in neonatal cholestasis: a pitfall in analysis of biochemical markers for Niemann-Pick type C disease
Polo, Giulia / Burlina, Alessandro / Furlan, Francesca / Kolamunnage, Thilini / Cananzi, Mara / Giordano, Laura / Zaninotto, Martina / Plebani, Mario / Burlina, Alberto

Reference intervals of plasma homoarginine from the German Gutenberg Health Study
Atzler, Dorothee / Appelbaum, Sebastian / Cordts, Kathrin / Ojeda, Francisco M. / Wild, Philipp S. / Münzel, Thomas / Blankenberg, Stefan / Böger, Rainer H. / Blettner, Maria / Beutel, Manfred E. / Pfeiffer, Norbert / Zeller, Tanja / Lackner, Karl J. / Schwedhelm, Edzard

TSH and fT4 during pregnancy: an observational study and a review of the literature
Joosen, Annemiek M.C.P. / van der Linden, Ivon J.M. / de Jong-Aarts, Neletta / Hermus, Marieke A.A. / Ermens, Antonius A.M. / de Groot, Monique J.M.

Mean corpuscular volume levels and all-cause and liver cancer mortality
Yoon, Hyung-Jin / Kim, Kyaehyung / Nam, You-Seon / Yun, Jae-Moon / Park, Minseon

Circulating endothelial-derived apoptotic microparticles and insulin resistance in non-diabetic patients with chronic heart failure
Berezin, Alexander E. / Kremzer, Alexander A. / Cammarota, Giovanni / Zulli, Anthony / Petrovic, Daniel / Martell-Claros, Nieves / Sabo, Jan / Kruzliak, Peter

Platelet aggregation in response to ADP is highly variable in normal donors and patients on anti-platelet medication
Dunne, Eimear / Egan, Karl / McFadden, Siobhán / Foley, David / Kenny, Dermot

EQA-derived metrics to assess overall instrument performance
Badrick, Tony / St John, Andrew

Misidentification in laboratory medicine and diagnostic process: a neglected problem calling for action
Toccafondi, Giulio / Tartaglia, Riccardo / Balboni, Fiamma / Tomei, Alessia / Pasquini, Viviana / Pezzati, Paola

Impact of the routine implementation of automated indirect immunofluorescence antinuclear antibody analysis: 1 year of experience
Mulliez, Sylvie M.N. / Maenhout, Thomas M. / Bonroy, Carolien

The importance of angiogenic markers in the differential diagnosis of HELLP syndrome vs. non-HELLP thrombocytopenia
Quirós, Covadonga / Suárez, Francisco / Prieto, Belén / Rodriguez, Verónica / Vaquerizo, Óscar / Álvarez Menéndez, Francisco V.

Bisalbuminemia accompanying bisalbuminuria detected in capillary electrophoresis, not in gel electrophoresis
Yang, Hyung-Seok / Cho, Sun Young / Kim, Young Jin / Park, Tae Sung / Lee, Hee Joo

Prognostic value of red blood cell distribution width in acute pancreatitis patients admitted to intensive care units: an analysis of a publicly accessible clinical database MIMIC II
Hu, Zhi-De / Wei, Ting-Ting / Tang, Qing-Qin / Fu, Hai-Tao / Yang, Min / Ma, Ning / Wang, Li-Li / Qin, Bao-Dong / Zhou, Lin / Zhong, Ren-Qian

Differences in analytical and biological results between older and newer lots of a widely used irisin immunoassay question the validity of previous studies
Montes-Nieto, Rafael / Martínez-García, M. Ángeles / Luque-Ramírez, Manuel / Escobar-Morreale, Héctor F.

A diagnostic algorithm for the detection of inhibitors against coagulation Factor V
Cadamuro, Janne / Skocic, Matthias / Meisl, Burgi / Raggam, Reinhard B. / Felder, Thomas Klaus / Prüller, Florian / Reinstadler, Kathrin / Wiedemann, Helmut / Mrazek, Cornelia

Interference of anticoagulants on coagulation testing
van de Kerkhof, Daan / Schmitz, Ellen / Moolenaar, Mitchel / Schellings, Mark / Boer, Arjen-Kars / Boonen, Kristel

Swiss MedLab 2016 and 74th Annual Meeting of the Swiss Society of Microbiology SSM, Bern, 13–16 June 2016

 Click here to see the future titles of Clin Chem Lab Med

Recording is available on-line! EFLM webinar on “The estimate of measurement uncertainty”

The estimate of measurement uncertainty
EFLM webinar held on May 10 by Ilenia Infusino, BSc.

For those who were not able to join the EFLM webinar on 10 May or for those attendants who want to recall presented ideas, we are happy to inform you that the recording of the EFLM webinar on “The estimate of measurement uncertainty” is now available:

ZIKA Virus

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Importance of pipetting in Clinical flow cytometry laboratories in Zimbabwe


The importance of good pipetting techniques for the proper measurement of CD4/CD8 for the management of patients with HIV necessitates regular assessment of pipetting techniques, accuracy and precision checks

Integrity of pipettes and good pipetting techniques are critical for accurate and reproducible results.

Pipette accuracy and precision checks should be peformed monthly and when indicated as part of troubleshooting corrective actions.

Pipetting techniques of new staff should be validated before the staff are certified to process patient samples.

Most techniques for pipette accuracy and precision checks are complex and require sophisticated analytical balances and extra laboratory space.

The Flow Cytometry Centre recommends a technique that does not require analytical balances .

The major advantage of the technique is that it does not require additional equipment and space.

Flow cytometers and pipettes already in use in the flow cytometry  laboratory is all that is required.

The technique is peformed using cheap commercial  low, medium and high  fluorescent beads and 3 or 4 colour  CD4/CD8 protocols (CDC/NIH 1998/2008 guidelines).

Pipetting technique, accuracy, precision and performance of single platform 3 and 4 colour protocols can all be assessed using this technique.



Fluorescent low, medium, and high beads are added to normal blood prepared for CD4/CD8 analysis as per CDC/NIH abbreviated 3 or 4 colour panels and analysed on a 3 or 4 colour flow cytometer.

The expected bead counts are compared to actual counts and the results are statistically analysed to aseess accuracy.

CD4 and CD8 counts of the normal blood are used to assess precision.



Pipetting technique, accuracy and precision should be checked monthly.

A simple, user friendly method that is compatible with flow cyometers currently in use at most reference and central hospitals in Zimbabwe can be easily utilized.

Provincial and district hospitals can regularly refer their pipettes to the nearest central or reference laboratory for precision and accuracy checks.

Details of the procedure and training are available from: Flow Cytometry Centre, suite 12A, 1st floor, Medical Centre, 52 Baines Avenue, Harare.


NCCLS guidelines

CDC/NIH guidelines

Flow cytometry centre SOP



HANDOVER CEREMONY OF THE ISO 15189 ACCREDITATION CERTIFICATE TO MR. M. NYAMWANZA. From left to right: Mr. M. Nyamwanza (MD Cimas Med Services Division); Mrs. Maureen Mutasa (CEO SADCAS): Dr. D. Parirenyatwa (Min. of Health and Child Care, Zimbabwe); Mr. D. Mangwanya (Director of Lab of Service-Zimbabwe & Chairperson of Lab Services in the SADAC region.



Challenges facing laboratories worldwide are to provide QUALITY services which include reliable and accurate medical results timeously. Resources are often limited hence the need to use them as efficiently and effectively as possible.

The Zimbabwe government reiterated the need to provide its citizens with quality medical services by strengthening evidence based medicine. One way to achieve this was through ISO 15189 accreditation for medical laboratories. Accreditation is a procedure by which an authoritative body gives formal recognition that an organization is compliant and competent to carry out specific tasks according to predetermined standards. This recognition puts us on the international map because test results that are produced at Cimas Medical Laboratories are acceptable worldwide reducing the need for medical tourism.

Road leading to accreditation

An initiative was rolled out by the government in collaboration with ZINQAP, CDC, WHO-AFRO where the SLMTA/SLIPTA program was unveiled. Strengthening Laboratory Management Towards Accreditation is a management tool that allows laboratories to progressively improve on their quality management system through a five tier rating system as they work towards ISO 15189 accreditation.

Stepwise Laboratory Improvement Processes Towards Accreditation is a framework to encourage, support and recognize the implementation of Quality Management System in medical laboratories in a stepwise manner.

Progression towards ISO 15189 accreditation

  • It was important to get buy in from management and staff. Initially this proved difficult because change is never easy and always is painful.
  • A quality steering committee was formed with a representative from each department chosen by staff members so as to get buy in from staff by actively involving them.
  • The committee then drew up a plan of activities which included internal audits and structured meetings.
  • Training requirements were identified and trainings were carried out.
  • All support staff participated in the accreditation process even though they were not directly involved.
  • Cimas Medical Laboratories management was totally committed. The Managing Director being the champion of accreditation was astute in identifying skills in his staff which resulted in persons being given tasks aligned to their skills in an effort to utilize talent towards achieving Accreditation.