Automation Hematology Program includes assessment for Alinity systems

Automation Hematology Program includes assessment for Alinity systems

Laboratory quality control programs of Controllab for hematology analysis in automated systems include Alinity systems and provide comparison between laboratories of users of this system.

Participating in the Proficiency Test (PT), the laboratory demonstrates the reliability of its analytical results, obtains assistance in identifying failures to take corrective or preventive actions and has the opportunity to identify trends that are not perceived otherwise

These benefits are provided in Controllab programs, which allow laboratories to periodically analyze the accuracy of their results. Among these programs, the Proficiency Test of Automation Hematology stands out, which is structured to meet the particularities of the different systems available in the diagnostic market.

A recent case is the Automation Hematology module type IV, which already included the analyzes for the SDH20 and Pentra 60/80/80 XL systems and, recently, included the Alinity h-series systems. With this addition, laboratories that have Alinity systems in their routine can compare their analysis in a laboratory quality control with liquid whole blood matrix materials. In the table at the end of this text, it is possible to identify the tests contemplated for the global and differential series of these systems.

The program follows the criteria of ABNT NBR ISO / IEC 17043 and is accredited by the Coordenação-Geral de Acreditação do Inmetro, under the number PEP 0003, according to the scope published in http://www.inmetro.gov.br/credenciamento/acre_prod_ep.asp.

When participating, the laboratory has access to a proficiency testing information management system that allows more agility and efficiency in performance analysis. The information is dynamic and simplifies the auditing processes, improving the knowledge of the analyzes.

See how the program works:

After interlaboratory comparison, graphs are available in the Controllab Online System for analyzing trends and helping to prevent and identify the causes of non-compliant results. In the system itself, histories can be recorded to track performance on the results.

The Automation Hematology Proficiency Test has four different programs available:

  • Automation Hematology I (All systems, except those included in programs II, IV and V)
  • Automation Hematology II (Cell Dyn Systems, except Sapphire and Esmeralda models)
  • Automation Hematology IV (Alinity, SDH20 and Pentra 60/80/80 XL systems)
  • Automation Hematology V (CellTac (Alfa MEK-6400/6410/6500, Es MEK-7300 and G MEK-9100), Counter 19, Micros (60 and ES 60), Mindray BC series, Pentra (120 DF / DX, 120 / Retic and DX Nexus) and Yumizen (H2500 / H1500 and H500)
EnsaiosHematologia Automação IHematologia Automação IIHematologia Automação IVHematologia Automação V
Hemácias    
Hemoglobina    
Hematócrito    
VCM    
HCM    
CHCM    
RDW    
Plaquetas    
VPM****
PCT****
PDW****
Leucócitos    
Diferencial (%)    
Neutrófilos   *
Linfócitos   *
Monócitos   *
Eosinófilos   *
Basófilos   *
Granulócitos   *
MID   *

*Essays offered as education

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PRM 0009

Certified Reference Material Producer

Accredited by Coordenação-Geral de Acreditação do Inmetro

Controllab has been accredited as a Certified Reference Material (CRM) Producer since 2016 by Cgcre, under number PMR 0009. The conformity assessment is carried out in accordance with the requirements established in ABNT NBR ISO 17034 and Inmetro standards, ensuring competence for the production of CRMs, as defined in the Scope of Accreditation.

This accreditation attests to Controllab’s technical competence in producing CRMs according to international requirements and enables it to be recognized in other countries, under mutual recognition agreements, thereby reducing technical barriers between Brazil and other countries across continents.

Materiais de Referência Certificados - PMR 0009 - ABNT NBR ISO 17034-Controllab
Cgcre is signatory to the Mutual Recognition Arrangements of the International Laboratory Accreditation Cooperation (ILAC) and Interamerican Accreditation Cooperation (IAAC).

CAL 0214

Calibration Laboratory

Accredited by Coordenação-Geral de Acreditação do Inmetro

In December 2002, the Calibration Laboratory was accredited by Cgcre. With this recognition, it became part of the Brazilian network of accredited laboratories, under number 214. Since then, it has been periodically evaluated for the maintenance and/or extension of its accreditation.

The Inmetro seal attests to Controllab’s technical competence, credibility, and operational capability for calibration services, in accordance with the requirements of ABNT NBR ISO/IEC 17025.

Calibração de Instrumentos - CAL 0214 - ABNT NBR ISO/IEC 17025 - Controllab
Cgcre is signatory to the Mutual Recognition Arrangements of the International Laboratory Accreditation Cooperation (ILAC) and Interamerican Accreditation Cooperation (IAAC).

PEP 0003

Proficiency Test Provider

Accredited by Coordenação-Geral de Acreditação do Inmetro

In September 2011, Controllab was accredited by Cgcre as a proficiency test provider, under nº PEP0003. Initially as part of a pilot project by Inmetro, this accreditation was based on ILAC G13: 2007 and included several clinical and hemotherapy tests. In the periodic evaluations of this accreditation, new segments and tests are included and the evaluation is now conducted according to ABNT NBR ISO/IEC 17043.

This accreditation attests to Controllab’s technical competence to develop and conduct proficiency tests in accordance with international requirements and enables it to be recognized in other countries, in accordance with mutual recognition agreements signed by Brazil in Mercosur, the Americas and Europe.

PEP 0003 - ABNT NBR ISO-IEC 17043 - Controllab

Cgcre is signatory to the Mutual Recognition Arrangements of the International Laboratory Accreditation Cooperation (ILAC) and Interamerican Accreditation Cooperation (IAAC).