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QUIK SAS- STAKEHOLDER MEMBER BIENNIAL (2018-2019)
ACTIVITY REPORT FROM JCTLM MEMBER ORGANIZATIONS
Metrological Traceability Organization: Quik SAS JCTLM Member status: Stakeholder Author: Porras-Caicedo, Aída
Author email: [email protected] Period covered: 2018 – 2019
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INDEX
1. Achievements in support of standardization in laboratory medicine .................................. 3
1.1 Harmonization of results in the clinical laboratory: ......................................................... 3
1.2 Quality assurance programs: .............................................................................................. 6
1.3 Consolidated JCTLM procedures and reference materials: ............................................... 7
1.4 Metrological traceability diagnostic matrix: ...................................................................... 8
2. Activities planned in support of standardization in laboratory medicine .......................... 10
3. Activities promoting traceability in the laboratory ............................................................. 11
4. Contribution to the implementation of the Reference Measurement System .................. 14
5. Comment and / or suggestions ............................................................................................ 14
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1. Achievements in support of standardization in laboratory medicine
During the year 2018 and 2019 the main achievements that QUIK has made in supporting the
standardization in laboratory medicine are:
1.1 Harmonization of results in the clinical laboratory:
Monthly performance analysis meetings are held with laboratory networks through the “CAP-LAN Comparative Analytical Perfomance of Laboratory Networks. Amont the laboratory neworks that we support are laboratotories located in differen tcities in
Colombia such as, Colsanitas Laboratory, Echavarria Medical Laboratory, South West
Network and Centro Oriente Network, The goal ob these meetings and reports are contribute
to improve the performance, the comparability and the stadanrdization of the patients results.
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1.2 Quality assurance programs: Quik SAS has seven external quality assurance programs
“QAP”, which covers the different areas of the clinical laboratory (Serum Chemistry,
Immunoassay, Coagulation, Hematology, Urinary Chemistry, Uroanalysis and Plasma
Proteins.
During the 2018-2019 period, a total of fifty laboratories participated in the different QAP
programs.
Through these programs, the comparison of the results issued by the laboratory with a
reference laboratory traceable to the JCTLM is promoted and a diagnosis of the metrological
traceability of the methods and materials used by the participating laboratory is made.
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1.3 Consolidated JCTLM procedures and reference materials: Consolidated in PDF of the
JCTLM reference methods and materials, in order to facilitate the traceability consultation
and diagnosis for clinical laboratories.
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1.4 Metrological traceability diagnostic matrix: The diagnostic matrix continues to be updated
as a support tool for clinical laboratories to consult their tests and determine whether or not
they are metrologically traceable.
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CÓDIGO: ADI-FOR-32VIGENTE DESDE: MARZO/01/2019VERSIÓN: 2PÁGINA: 1 DE 1
N AnalitoMetodología declarada por el manufacturador
Metodología de referencia avalada por el JCTLM
Material declarado por el manufacturador
Material de referencia avalado por el JCTLM Calificación
1 AFP (Alfafetoproteína)
Inmunoensayo de quimioluminiscencia de partículas paramagnéticas.Ensayo inmunoenzimático de dos posiciones ("sandwich").
No declarado
1er Patrón Internacional de la OMS 72/225 Norma EN ISO 17511.
BCR-486 No Trazable
2 HBc AbAnticuerpo del centro del virus de la hepatitis C
Inmunoensayo de Quimioluminiscencia No declarado
Calibradores de trabajo delfabricante .Norma EN ISO 17511.
No declarado No Aplica
3
(HBs Ab)Anticuerpo de la superficie del virusde la hepatitis B
Inmunoensayo de quimioluminiscencia de partículas paramagnéticas.Ensayo inmunoenzimático de dos posiciones ("sandwich").
No declarado
1ª Preparación deReferencia Internacional de la OMS para la inmunoglobulina anti-hepatitis BNorma EN ISO 17511.
No declarado No Aplica
4
(TgAb)Thyroglobulin Antibody II (Anticuerpos de tiroglobulina).
Inmunoensayo de quimioluminiscencia de partículas paramagnéticas.Ensayo inmunoenzimático de dos posiciones ("sandwich").
No declarado
PatrónInternacional 65/93 de la OMS.Norma EN ISO 17511.
No declarado No Aplica
5 TPO Antibody (Anticuerpo anti-peroxidasa).
Inmunoensayo de quimioluminiscencia de partículas paramagnéticas.Ensayo inmunoenzimático de dos posiciones ("sandwich").
No declarado
Patrón internacional 66/387 de laOMS Norma EN ISO 17511.
No declarado No Aplica
Manufacturador
MATRIZ DIAGNÓSTICO TRAZABILIDAD METROLÓGICA
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2. Activities planned in support of standardization in laboratory medicine
For the period 2020 - 2021 Quik plans to develop the following 20 activities to promote
metrological traceability mainly related to academic events, IT developments and external quality
programs. YEAR FIRST SEMESTER SECOND SEMESTER
2020
1
Publication Article: The relationship between
Metrological Traceability and Comparability of
Results for 12 analytes in 5 laboratory
measurement systems
6 Participation in the National Bacteriology
Congress, with a metrological traceability
conference
2
Participation in the International Symposium
on Comprehensive Diagnosis organized by
Colsanitas, with a metrological traceability
conference
7 Participation in the International Symposium of
the University of Santander, with a metrological
traceability conference
3 Breakfast with Laboratory Managers,
socialization article Bogotá and Medellín 8
Breakfast with Laboratory Managers,
soclialization article Cali, Bucaramanga
4 Diagnosis of Metrological Traceability for
Laboratories 9
Participation in the XXV ALAPAC Chile
Congress, with a metrological traceability
conference
5 Event in conjunction with the Association of
Bacteriologists of Bogota and Cundinamarca,
with a metrological traceability conference
10 Diagnosis of Metrological Traceability for
Laboratories
YEAR FIRST SEMESTER SECOND SEMESTER
2021
1 Event in conjunction with the Association of
Bacteriologists of Santander, with a
metrological traceability conference
6 Metrological Traceability Workshop in
Bucaramanga
2 Diagnosis of Metrological Traceability for
Laboratories 7 Metrological Traceability Workshop in Medellín
3 Metrology Traceability Workshop in Bogotá 8 Diagnosis of Metrological Traceability for
Laboratories
4 Publication Article: Metrological traceability in
alliance with laboratories in Colombia 9 Metrological Traceability Workshop in Cali
5 Promotion of metrological traceability
diagnosis 10
Participation in the National Bacteriology
Congress, with a metrological traceability
conference
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3. Activities promoting traceability in the laboratory
Quik has promoted metrological traceability, participating and performing the following academic
activities:
3.1 Conference: Diagnostic Socialization of Metrological Traceability Academic session in Medellín, Colombia. On February 1, 2018, the Diagnostic
Socialization of Metrological Traceability was carried out at the facilities of the Reference
Medical Laboratory in Medellín Antioquia. The agenda developed was: To know the
results of metrological traceability for each technology analyzed, to socialize the JCTLM
and its functions and to know the JCTLM page and the options to know the materials and
reference methods for the tests.
Date: February 1, 2018
Academic session
Led by: Quik SAS
Location: Medellín, Colombia
3.2 Conference: From Colombia to the world: Harmonization and analytical performances in the world's top. Network of Clinical Laboratories Colsanitas-Colombia In the academic framework of the Symposium, Quik participated with the From Colombia
to the world: Harmonization and analytical performances in the world's top Network of
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Clinical Laboratories Colsanitas-Colombia conference, taught by Dr. Aída Porras Caicedo
where the metrological traceability of the magitudes.
Date: June 7 and 8, 2018 III International Symposium in integral
diagnosis: Dilemmas in the daily practice of
clinical laboratory and pathology
Led by: Colsanitas
Location: Bogotá Colombia
3.3 Conference: Uncertainty of measurement in medical laboratory. Trends, proposals, approaches
Academic session in Medellín, Colombia. On September 10, 2019, at the facilities of the
Reference Medical Laboratory in Medellín Antioquia, the training "Metrological Traceability
and Measurement Uncertainty" was conducted. The agenda developed was revision and
socialization of Metrological Traceability and Measurement Uncertainty.
Date: September 10, 2019 Academic session
Led by: Quik SAS Location: Medellín, Colombia
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3.4 Training: Metrological Traceability and Measurement Uncertainty
Training is carried out for the Echavarria Medical Laboratory, the general objective was to
understand the concepts of measurement uncertainty.
Date: October 22, 2019 Academic session
Led by: Quik SA Location: Medellín, Colombia
3.5 Conference: Analytical quality control techniques based on patient results. Dr. Aída Porras, manager of Quik, Doctor of Management (PhD), Master in Biology with
emphasis in clinical biochemistry, led the conference called Analytical Quality Control
Techniques based on patient results on November 2, 2019 and highlited the importance
of metrological traceability to deliver trust results.
Date: From November 1 to 4, 2019
XIX International Congress Of “Colegio
Nacional de Bacteriología”
Led by: Colegio Nacional de Bacteriología
Location: Bogotá Colombia
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4. Contribution to the implementation of the Reference Measurement System
Quik has contributed to the performance analysis and diagnosis of metrological traceability of 12
analytes out of 51 that are currently traceable to the highest hierarchical order (traceable
according to the material and reference methods), for commercial house medicine systems most
used worldwide Roche (Cobas), Ortho-Clinical Diagnostics- OCD- (Vitros), Siemens Healthineers
(Advia), Abbott (Architect) and Beckman Coulter.
5. Comment and / or suggestions
As a suggestion we want to know if we can count on the participation of members of the JCTLM to the
national and regional events held by Colombia, such as the National Congress of Bacteriologists and
the Academic Symposium organized by the University of Santander - UDES.