Bureau Veritas introduces quality management system at Diagen Plus
diagnostic laboratory

2971

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.