Bureau Veritas introduces quality management system at
Diagen Plus diagnostic laboratory
14-03-2009 16:00:00 | Armenia | Economy
YEREVAN, MARCH 14, MOYAN TAPAN. Bureau Veritas corporation,
an international leader in certification sector, has introduced
a quality management system in line with ISO 9001:2000
international standard at Yerevan-based Diagen Plus laboratory.
The introduction process lasted 6 months, after which the
certification of Diagen Plus was carried out in 2008, NT
correspondent was informed by Stepan Barakian, Head for
Development of Bureau Veritas in Armenia.
He said that the introduction of the quality management
system has resulted in great positive changes in work of Diagen
Plus: "jointly, step by step, conducting internal audits,
measuring the results, correcting the deviations, improving the
processes and controlling them by means of analysis, Diagen Plus
has a potential opportunity to conduct a lot of diagnostic
tests".
According to the co-founder of the laboratory, Prof. Levon
Karabalian, the purpose of introducing a quality management
system at Diagen Plus founded in 2004 was that to organize work
at the laboratory in such a way that "first of all, the staff
will be sure that the results of the tests are correct".
The Director of Diagen Plus, Doctor Arsen Zakarian informed
NT correspondent that a mechanism of weekly control is now used
at the laboratory: every week a test done during that period is
checked as an "attested control serum", which enables to analyse
all the processes at the laboratory. Besides, another mechanism
of control was recently introduced at the laboratory: for
example, out of 100 serums subjected to tests during a day, 2-3
"anonymous" serums are tested the next day too. According to A.
Zakarian, there was only one case of inaccuracy, which was
corrected before the patient received the test results.
The scope of control has a third mechanism as well. In 2008
Diagen Plus was included in the system of international external
control of quality of medical laboratories, under which the
reference institute - German DGKL (Deutcshe Variente
Gesselschaft fur Klinische Chemie und Laboratoriumsmedizin e.V.-
Referenzinstitut fur Bioanalytic) regularly sends Diagen Plus 2
pairs of serums already subjected to analysis. Diagen Plus has
already passed 3 checks receiving the respective certificate of
DGKL. It plans another 6-8 checks in 2009.
L. Karabalian said that thanks to such attention to the
quality of their services, the number of those visiting Diagen
Plus has grown in the past 3-4 months. Diagen Plus carries out
almost the complete range of laboratory diagnostic tests: urine
analysis, blood test, clinical biochemical analysis, as well as
tests of all the chemical substrata, ferments, electrolytes,
diabetes, thyroid gland, coagulability, infections, lipid
metabolism, reproductive function, myocardium, oncological
markers.
"I as a founder is quite satisfied that the quality
management system is used at Diagen Plus, and we envisage
continuing work in this direction as we have a bit more complex
problem," L. Karabalian said. S. Barakian explained that as a
result of introduction of the quality management system at
Diagen Plus, the problem of introducing ISO 17 000 laboratory
certification standard has matured. "Bureau Veritas can make
comparisons with Europe, and I as an expert who has worked both
in Europe and Armenia can say that there are only insignificant
differences in the work style of Diagen Plus and those European
labs that I have seen in the past 30 years," S. Barakian noted.
As for the connection with medical institutions, L.
Karabalian said that tests on mutations of the blood
coagulability system are quite specific and considered as
important by surgeons, but few medical institutions previously
required that patients have such tests prior to an operation.
However, after the seminars held at Diagen Plus, several
hospitals began sending regularly their pateints for tests on
such mutations. "It is one example of establishing a medical
institution - patient - laboratory link, but there are other
ways to create links, ranging from dissemination of print
materials to individual talks with doctors". The scientist added
that many doctors call to receive comments on test results, but
the laboratory is not an institition to make diagnosis: it is a
generally accepted principle.