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            Proficiency Testing

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            Ensaio de Proficiência (EP)
            EXCELLENCE IN CLINICAL ANALYSIS

            Demonstrate the reliability of your results​

            The Proficiency Testing (EP), also known as External Quality Control (EQC), is an effective quality control tool for determining the analytical performance of the laboratory and a necessary requirement for laboratory accreditation processes (ISO 15189, ISO 17025, PALC-SBPC/ML, DICQ-SBAC, etc.) and regulatory bodies.

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            Controllab Catalog

            Get to the broad portfolio, with more than 3,500 tests covered by quality control and sign up to highlight the quality of the tests performed in your routine.

            KNOW MORE
            What is the Proficiency Testing for?
            Why participate in the Proficiency Testing?
            Benefits of participating in the Proficiency Testing
            What is the Proficiency Testing for?
            Why participate in the Proficiency Testing?

            QUALITY

            The demand for this service and other control tools exists because the variation of the results is inherent to the process, that is, the results will always have some random and systematic variation associated. Every effort is made to minimize variations as much as possible and keep them under control, so as not to impact routine results.
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            Benefits of participating in the Proficiency Testing

            desempenho

            PERFORMANCE

            In addition to demonstrating the reliability of analytical results, assisting in identifying failures and enabling corrective or preventive actions to be taken and fulfilling accreditation and regulatory requirements, the Proficiency Testing also enables market comparison and the identification of trends that are not perceived otherwise. The main feature of the Program is to indicate the analytical accuracy of the laboratory. The tool is efficient for assessing technical quality and ensuring the reliability of results.

            Learn more about the benefits

            Standardize the analytical stage against the market

            Assess the efficiency of internal control and ensure its suitability for specific methods

            Evaluate and monitor the performance of laboratories in specific tests

            Identify hits and compliance

            Determine the performance characteristics of already established methods and/or new methods and technologies

            Provide corrective/preventive actions

            In summary, in addition to assessing technical quality, the Proficiency Testing is:

            Mandatory by regulatory bodies

            Accreditation process and bidding prerequisites

            Requirements for accreditation with the main health insurers

            Differential against to the competition

            ACCREDITATIONS AND
            RECOGNITIONS

            Continuous improvement, based on quality and reliability, has given Controllab some recognition for the Proficiency Testing:

            PEP 0003 - ABNT NBR ISO-IEC 17043 - Controllab
            CRL 0586 - NBR ISO-IEC 17025 - Controllab

            According to the scopes
            published in www.inmetro.gov.br

            selo_iso_9001
            selo_anvisa_bpf

            How can Proficiency Testing
            help in your laboratory?

            auxilia rotina laboratorial 5

            ASSIST THE LABORATORY ROUTINE

            Assessments are continuous, with regular intervals, annual targets and multiple items in varying concentrations. These assessments are the result of statistical studies and analysis by experts, whose reports commonly point out errors, possible causes and considerations on the overall performance of the participants. These actions take place so that each one can compare their performance with the others, at the moment and over time.

            MANAGE ANALYTICAL PERFORMANCE

            Management information is dynamic and optimized, with indicators and graphs that facilitate the identification of the laboratory’s analytical performance and provide an agile and objective analysis of the tests that need immediate action.

            gerencia desempenho analitico 1
            simplifica processos auditoria 1

            SIMPLIFIES THE AUDIT PROCESSES

            Controllab’s Proficiency Testing keeps track of performance on results. It provides a list with possible causes of non-conforming results and centralizes the information in the same environment, for management evolution and evidence in audits.

            How it works?

            Learn more about how Controllab Proficiency Testing works by clicking on the steps below.

            Service
            Participants
            Rounds
            Evaluation
            Reports
            Management
            Service

            Service

            Proficiency Testing with rounds at regular and continuous intervals, annual targets and multiple items with unknown results for analysis. Structured in ABNT NBR ISO/IEC 17043.

            Participation is simple and carried out in 3 stages:

            Proficiency Testing programs are organized in the form of rounds, grouped in an annual calendar. In these rounds, a set of items (samples) with unknown results are sent simultaneously to the participating laboratories in order to carry out the relevant analyzes. For virtual items, this step is suppressed.

            Testing by the participating laboratory shall be performed in a manner similar to the routine of testing. Subsequently, Controllab should be provided with information such as: results, methods, equipment, reactives, among others, used to perform the analyses.

            After receiving the information, Controllab issues individual laboratory evaluation reports, global statistical reports with technical and market information and where relevant, technical considerations and reports of Controllab’s scientific advisors.

            Test Items

            Multi-level items, concentrations and matrices. Among the matrices included in the programs, are listed: serum, blood, urine, synovial and pleural fluids, liquor, sperm, fungi, feces, hair, water, food, etc. The test items must have the quantity observed under the aspect of similarity with the matrix analyzed in the laboratory routine, similarity of the concentration range, levels or qualitative characteristics of the test in view of its homogeneity and stability and the quantity supplied is sufficient for the performance. of the test without significant changes in routine.

            Virtual Microscopy

            There are tests where the scarcity of raw material or low stability for making the item can make a quality control program unfeasible, requiring the use of other comparison and control techniques. Controllab, to assist human and veterinary microscopy clinical tests, uses Virtual Microscopy technology in favor of quality to expand the variability of cases, allow the participation of more laboratories and standardize the content for users. Tools for analyzing virtual slides and videos are made available in the Online System and, when necessary, clinical cases and images are added. With this tool, the laboratory technician works with the same resources as in the physical microscope, but in a digital way.

            Participants

            Participantes

            Organizações de diferentes portes comparam suas análises com laboratórios consolidados em excelência analítica.

            Abrangência

            O Ensaio de Proficiência da Controllab é dimensionado de acordo com o perfil do laboratório, proporcionando um controle de qualidade adequado às necessidades e ao porte do participante. São mais de 3.500 ensaios disponíveis em múltiplas áreas para o controle de qualidade. Essa diversidade de exames visa suprir as demandas dos laboratórios e crescente inovação tecnológica dos segmentos, atendendo aos processos de acreditações laboratoriais e aos órgãos regulamentadores. O Ensaio de Proficiência dispõe de programas específicos por metodologias e sistemas, quando indicado. Eles proporcionam avaliações mais fidedignas das análises. Dispõe também de ensaios em diferentes matrizes e concentrações para uma cobertura mais abrangente da rotina.

            Rounds

            Rounds

            Sending samples that simulate routine testing. The laboratory reports the results online together with information from the analytical system for Controllab to perform the comparison and evaluation.

            Online System

            When enrolling in Controllab Proficiency Testing programs, the laboratory will have access to the “Online System” via the company’s website. This connection allows access to information and tools for managing programs. The “Online System” provides several resources such as: monitoring of sample shipments, control of results to be sent, new evaluation reports, communications and general information. For laboratories with more than one technical unit, a tool is made available for the administrator to monitor the analytical performance of multiple laboratory units in an easy and unified way.

            Administration

            The participant must designate a program “administrator” to manage the relationship between Controllab and the laboratory, ensure compliance with all participant commitments, critically analyze the results and define improvement actions. The guarantee of confidentiality is conferred (a) by the numerical identification of the participant, unique and non-transferable; and (b) the use of unique passwords to access data

            Evaluation

            Evaluation

            Comparison based on the most specific groups and limits applied according to statistical studies based on ABNT NBR 13528.

            Results Evaluation

            The evaluation process takes place after receiving the results by a deadline. Then, statistical and technical analysis is performed, which includes the identification of new techniques and verification of atypical behaviors. These behaviors require a more complex analysis of the data, such as reanalysis of material (quality control of the material), discussion with scientific advisors, contact with users/manufacturers or conducting research.

            Reports

            Reports

            Individuals with the performance of the round and graphs of the Deviation Index and Z Index; global market with technical and marketing information and continuous performance over the period.

            Evaluation Report (Individual)

            The evaluation report presents the evaluations (conforming and non-conforming) of the analyzes obtained by the laboratory in the participation of the proficiency testing in the round and between the cumulative rounds. It includes graphs (deviation Index and Z Index) and information about monitoring total and systematic error, estimating trends and data variation. In addition to the evaluations, the report provides statistical information that allows the laboratory to monitor its analytical performance against the market.

            Results Profile (Public)

            This report presents the statistical results with the performance of all analytical systems, allowing the laboratory to compare its systems against the market and its group. In addition to statistical information, when necessary, considerations, bibliographic references and technical reports from Controllab’s scientific advisors are provided.

            Management

            Management

            Management center with summary of analytical performance and indicators to achieve the goals of excellence in analysis.

            Analytical performance management

            Dynamic and summarized information center to facilitate the overall analysis of the laboratory’s analytical performance. It allows you to check overall performance over time and identify which analyzes need immediate action. In addition, it has analytical indicators to achieve the goals of excellence in the test and facilitate decision making.

            How it works?

            Learn more about how Controllab Proficiency Testing works by clicking on the steps below.

            Service

            Proficiency Testing with rounds at regular and continuous intervals, annual targets and multiple items with unknown results for analysis. Structured in ABNT NBR ISO/IEC 17043.

            Participants

            Organizations of different sizes compare their analysis with consolidated laboratories in analytical excellence.

            Rounds

            Sending samples that simulate routine testing. The laboratory reports the results online together with information from the analytical system for Controllab to perform the comparison and evaluation.

            Evaluation

            Comparison based on the most specific groups and limits applied according to statistical studies based on ABNT NBR 13528.

            Reports

            Individuals with the performance of the round and graphs of the Deviation Index and Z Index; global market with technical and marketing information and continuous performance over the period.

            Management

            Management center with summary of analytical performance and indicators to achieve the goals of excellence in analysis.

            What can the Controllab Proficiency Testing Program do for your laboratory?

            The delivery of health services linked to quality is a constant concern. For this reason, the Proficiency Testing assists laboratories so that they can guarantee quality delivery, in addition to allowing continuous improvement in their processes. With continuous participation in the Proficiency Testing, the laboratory demonstrates competence to perform a certain test or measurement.

            Promotion

            Continuous participation is an investment in quality and can be disclosed through the registration certificate, disclosure seal and certificates of proficiency.

            The certificate of enrollment and the quality control seal are available after 3 months of participation in the program. Annually, the laboratory receives the certificate of proficiency for the tests that obtained continuous participation and that reached the minimum level of performance.

            These documents demonstrate the commitment of the laboratory to proficiency testing and support the marketing of the laboratory, favoring the transparency of information and valuing participation in the service.

            They have a format that gives more trust and credibility to customers, doctors, patients, auditors and other stakeholders in the organization.

            Labnetwork materia Controllab 108 img03 1
            divulgue seu certificado EN
            Labnetwork materia Controllab 108 img04 1
            ACCESS OUR GUIDE TO DISCLOSE YOUR CERTIFICATE
            sbpc

            The Clinical Proficiency Testing has the seal of the Brazilian Society of Clinical Pathology/Laboratory Medicine (SBPC/ML).

            SBMV - Sociedade Brasileira de Medicina Veterinária

            The veterinary program is supported by the Brazilian Society of Veterinary Medicine (SBMV).

            mockup folder en

            HAVE AN ENVIRONMENT WITH ANALYSIS OF EXCELLENCE

            Controllab offers complete solutions for quality and assertiveness of results. These solutions facilitate recognition for accreditation processes and regulatory bodies.

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                      PEP 0003

                      Acreditação Cgcre/Inmetro - Provedor de Ensaio de Proficiência

                      Em setembro de 2011, a Controllab foi acreditada pela Coordenação Geral de Acreditação (CGCRE) do Inmetro como provedor de ensaio de proficiência, sob o nºPEP0003. Inicialmente dentro de um projeto piloto do Inmetro, esta acreditação baseou-se na ILAC G13: 2007 e incluiu diversos ensaios clínicos e de hemoterapia. Nas avaliações periódicas desta acreditação novos segmentos e ensaios são incluídos e a avaliação passa a ser conduzida segundo a ABNT NBR ISO/IEC 17043.

                      Esta acreditação atesta a competência técnica da Controllab em desenvolver e conduzir ensaios de proficiência conforme requisitos internacionais e a habilita reconhecida em outros países, conforme acordos de reconhecimento mútuo firmados pelo Brasil no Mercosul, Américas e Europa.

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                      Ensaio de Proficiência - PEP 0003 - ABNT NBR ISO/IEC 17043 - Controllab

                      A Cgcre é signatária dos Acordos de Reconhecimento Mútuo da International Laboratory Accreditation Cooperation (ILAC) e da Interamerican Accreditation Cooperation (IAAC)

                      CRL 0586

                      Acreditação Cgcre/Inmetro - Laboratório de Controle

                      Em dezembro de 2012, o Laboratório de Controle, responsável pelas análises de controle de processo e controle de qualidade dos materiais preparados pela Controllab para atender ao Ensaio de Proficiência e Controle Interno foi acreditado pela Coordenação Geral de Acreditação (CGCRE) do Inmetro, tornando-se parte integrante da rede brasileira de laboratórios acreditados, sob o nº 0586.

                      O selo do Inmetro atesta competência técnica, credibilidade e capacidade operacional da Controllab para a realização de ensaios, conforme requisitos da ABNT NBR ISO/IEC 17025.

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                      acessar escopo acreditado
                      Ensaios - CRL 0586 - NBR ISO/IEC 17025 - Controllab

                      A Cgcre é signatária dos Acordos de Reconhecimento Mútuo da International Laboratory Accreditation Cooperation (ILAC) e da Interamerican Accreditation Cooperation (IAAC)

                      Certificado ISO 9001

                      Em junho de 2003, a Controllab teve seu sistema de gestão da qualidade certificado na ABNT NBR ISO 9001 pela Bureau Veritas/Inmetro (âmbito nacional) e Bureau Veritas/UKAS (âmbito internacional), como “provedor de ensaio de proficiência em ensaios clínicos, fisico-químicos e microbiológicos”. Desde então, é avaliada periodicamente para manutenção e/ou revalidação da certificação.

                      acessar certificado Bereau Veritas/ukas
                      acessar certificado Bereau Veritas/inmetro

                      Certificado BPF/ANVISA

                      Materiais para controle de qualidade

                      Em outubro de 2012, a Controllab recebeu a certificação de Boas Práticas de Fabricação de produtos para saúde, concedida pela Anvisa. Essa certificação é relativa à produção de produtos para saúde para fins de controle de qualidade de laboratórios.

                      O processo de certificação é voluntário e conduzido conforme requisitos da Resolução RDC n.º 665 de 30 de março de 2022 (BPF para produtos para diagnóstico para uso in vitro). Durante o processo, a Controllab é inspecionada periodicamente (como correlata), pela Vigilância Sanitária para verificação das boas práticas de fabricação.

                      A ANVISA é uma agência regulamentadora vinculada ao Ministério da Saúde do Brasil, que tem a missão de proteger e promover a saúde, garantindo a segurança sanitária de produtos e serviços. Embora o registro junto a Anvisa não se aplique aos materiais da Controllab (RDC n.º 36/2015, Artigo 2º, Parágrafo Único, I), a certificação em BPF é aberta.

                      acessar certificação

                      PEP 0003

                      Accreditation Cgcre/Inmetro - Proficiency Test Provider

                      In September 2011, Controllab was accredited by Inmetro’s General Coordination for Accreditation (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.

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                      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).

                      CRL 0586

                      Accreditation Cgcre/Inmetro - Control Laboratory

                      In December 2012, the Control Laboratory, responsible for the analysis of process control and quality control of the materials prepared by Controllab to meet the Proficiency Test and Internal Control, was accredited by Inmetro’s General Coordination for Accreditation (CGCRE), becoming if part of the Brazilian network of accredited laboratories, under Nº 0586.
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                      CRL 0586 - 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).

                      ISO 9001 Certified

                      In June 2003, Controllab had its quality management system certified in ABNT NBR ISO 9001 by Bureau Veritas/Inmetro (national scope) and Bureau Veritas/UKAS (international scope), as “proficiency test provider in clinical tests, physical-chemical and microbiological”. Since then, it has been periodically evaluated for maintenance and/or revalidation of certification.
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                      BPF/ANVISA Certificate

                      Quality control materials

                      In October 2012, Controllab received the certification of Good Manufacturing Practices for health products, granted by Anvisa. This certification relates to the production of health products for laboratory quality control purposes.

                      The certification process is voluntary and conducted in accordance with the requirements of Resolution RDC No. 665 of March 30, 2022 (GMP for diagnostic products for in vitro use). During the process, Controllab is periodically inspected (as related) by the Sanitary Surveillance to verify good manufacturing practices.

                      Anvisa is a regulatory agency linked to the Ministry of Health of Brazil, whose mission is to protect and promote health, ensuring the health safety of products and services. Although registration with Anvisa does not apply to Controllab materials (RDC No. 36/2015, Article 2, Sole Paragraph, I), GMP certification is open.

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                      Request Controllab's Proficiency Testing (EP) and gain reliability, quality and improve analytical performance for the laboratory.

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                      PRM 0009

                      Accreditation Cgcre/Inmetro - Certified Reference Material Producer

                      Controllab has been accredited as a Certified Reference Material Producer (MRC) since 2016 by Inmetro’s General Coordination for Accreditation (CGCRE), under the PMR 0009 number. The assessment of this conformity is carried out according to the requirements established in ABNT NBR standards ISO 17034 and Inmetro, thus ensuring competence for the production of MRCs, according to the Scope of Accreditation.
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                      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

                      Accreditation Cgcre/Inmetro - Calibration Laboratory

                      In December 2002, the Calibration Laboratory was accredited by Inmetro’s General Coordination for Accreditation (CGCRE). With this recognition, it became an integral part of the Brazilian network of accredited laboratories, under nº214. Since then, it is periodically evaluated for the maintenance and/or extension of accreditation.

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                      access accredited scope - RBC/Cgcre/Inmetro - Massa
                      access accredited scope - RBC/Cgcre/Inmetro - Volume and Specific Mass
                      access accredited scope - RBC/Cgcre/Inmetro - Pressure
                      access accredited scope - RBC/Cgcre/Inmetro - Temperature
                      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).

                      Certificado em período de renovação.

                      Certificate in renewal period.