analytical activities.
Pre-analytical aspects include consultation on
appropriate investigations, patient preparation for
sampling, and sample collection techniques.
Analytical aspects include proeectures for
calibration, analysis, interna! quality contt·ol and
externa] quality assessment Post-analytical aspects
include proeectures for authorisation, timely and
accurately reporting, and consultation on the in–
terpretation of results in relation to diagnosis,
treatment, prognosis and further investigations.
There exist international standards for
certification (ISO900 l) and for accreditation (EN
4500 and ISOGuide 25). Howeverthese standards
are either very general (ISO 9001) , or are
developed for testing and calibration laboratories
(EN 4500 l, ISO Guide 25), and therefore do not
actdress specific aspects of the work of medical
laboratories. The scope of medical and clinical
laboratories is different fromthese laboratories and
needs additional criteria.
The Warking Group on Harmonisation of
Quality and Accreditation Systems of EC4 has
prepared a set of documents describing essential
criteria for quality systems inmedicallaboratories
to clarify the specific needs.
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7
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8
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9
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Clinical
laboratories that have implementedquality systems
based on the Essential Criteria fulfill all criteria
for accreditation. EC4 considers this as a Euro–
peanUnion harmonised accreditation system. EC4
provides guidelines for implementation of total
quality systems inmedicallaboratories. It is easily
applicable for multi disciplinary and other types
of medical laboratories. The quality systems of
medicallaboratorieswould reflect the special tasks
of such laboratories.Therefore, the emphasis is on
all previously described phases. Not only on
analytical and observational aspects, but also on
the pre-analytical and post-analytical phases, on
consultation and on efficacy and efficiency of
requested investigations.
A medical laboratory that has implemented a
quality system according to the criteria described
in theEC4document, fulfills ISO900 l ,E 4500 l
and ISO Guide 25 standards that are relevant to
medical laboratories, and is prepared for
accreditation or certification by all relevant sche–
mes. Particularly schemes originating, though
independent!yoperating, from the professions, like
84
theBelgian system,CCKLtest in theNetherlands,
CPA in the United Kingdom, the French GBEA
system, are suited for such accreditation. Guide–
lines published by these organisations are in
agreementwith the present international document
and the Handbooks and Mode! Quality Manuals
based on the guidelines and issued in these
countries are of use for laboratories wishing to
implement a quality system based on the present
document.
The new ISO/DIS 15189 recognises the special
position ofmedical laboratories much betterthan
the ISO25Guide.TheEC4Essentia! Criteria have
strongly influenced the contents of this draft
document. From it the following text is derived:
"Medical laboratory services, including
appropriate consultation services, are essential to
patient care and therefore should be available to
meet the needs ofall patients, their physicians, and
otherclinical personnel responsible for patient care.
Specific functions include requisition, patient pre–
paration, collection (where applicable), proper
identification, transportation, storage, processing,
and examination of clinical samples with
subsequent reporting of results. When necessary
medical laboratory services should include the
examination of patients in consultation cases and
active participation in prevention, diagnosis, and
management of patients. Each service should also
provide suitable educational and scientific
opportunities for the academic and technical staff.
Governmental bodies may provide license to a
medical laboratory to do certain examinations
(tests) on specified conditions."
The Executive Board of EC4 therefore
recommends that ISO/DIS 15189 "QualityMana–
gement in the Medical Laboratory" be supported
as a reference document for laboratory accredi–
tation. Its final version should be considered
tagether with the EC4 Essential Criteria when
defining a national scheme for laboratory
accreditation.
As an extension of its activities in the field of
accreditation EC4 has recently also taken the
initiative to create a European Ca-operation for
Accreditation ofMedical Laboratories (ECAML),
as a commission to harmonize the work of natio–
nal accreditation bodies.
Klinisk Kemi
i
Norden4. 1999
