quick sas - jctlm member activity reportquimioluminiscencia no declarado calibradores de trabajo del...

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Calle 63C No. 35 – 13 / (+57 1) 222 91 51 – 318 271 16 49 Línea gratuita Nacional: 018000 413 613 / [email protected]

SI-CER638958

Quik-membrete(v4)-8112019

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


No declarado

1ª Preparación deReferencia Internacional de la OMS para la inmunoglobulina anti-hepatitis BNorma EN ISO 17511.


4

(TgAb)Thyroglobulin Antibody II (Anticuerpos de tiroglobulina).


No declarado

PatrónInternacional 65/93 de la OMS.Norma EN ISO 17511.


5 TPO Antibody (Anticuerpo anti-peroxidasa).


No declarado

Patrón internacional 66/387 de laOMS Norma EN ISO 17511.


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


conference

5 Event in conjunction with the Association of

Bacteriologists of Bogota and Cundinamarca,

with a metrological traceability conference


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


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


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.

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