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Introduction
OLA is operated by QMP–LS
and is funded by Ontario’s MOHLTC. OLA is mandatory for all licensed
Ontario medical laboratories and others may subscribe voluntarily.
Definition
Accreditation is
a peer review assessment process by which an authoritative body
ensures that laboratories meet explicit quality management criteria,
in order to provide formal recognition that the laboratory is
competent to carry out examinations. Standards for accreditation are
identified in advance. Accreditation requirements translate the
standards into explicit criteria for accreditation. Assessments
determine if laboratories conform to requirements, for all
examinations performed for diagnosis, prophylaxis and treatment of
humans. All activities and all premises associated with the scope of
testing proposed for accreditation, are subject to assessment.
Assessment
Scope
QMP–LS/OLA
accredits diagnostic medical laboratories for which the ISO 15189:2003
Medical Laboratories – Particular requirements for quality and
competence standard is applicable.
OLA’s
accreditation process includes regular peer assessment visits (at
minimum every five years) and self-assessments that occur between
visits. Regular peer assessment visits and self-assessments encompass
all aspects of laboratory practice. Program requirements are
comprehensive and process-based. They focus on the management of
quality to reduce errors. They require laboratories to implement
inter-related processes that create a failure-resistant system in
which it is difficult to do the wrong thing and easier to do the right
thing. If mistakes occur, the root cause is determined and the process
re-defined. Assessments validate that quality management processes are
in place. Depending on the size and scope of the laboratory, an
accreditation assessment visit will be 1–4 days in length.
Initial peer
assessments, reassessments and self-assessments encompass all
activities and all premises associated with the scope of testing
proposed for accreditation. A focused surveillance on-site visit may
be conducted due to changes in laboratory ownership, location or menu
of tests, self assessment concerns, removal from the non-proficient
list, imminent expiry of a 2-year certificate, or due to other
concerns regarding a threat to patient safety. In these instances, the
exact focus of the assessment will be identified in advance. (See
“The Surveillance Assessment Visit”).
Assessment
Frequency
Regular peer
assessment visits occur at minimum once every five years. In addition,
laboratories are required to complete a self-assessment mid-cycle and
submit their report to QMP–LS. Within two years of certificate
issue, laboratories receive notification of self-assessments. Detailed
results of the self-assessment must be documented along with
deficiencies and corrective actions. Results of the self-assessment
are reviewed during the next scheduled accreditation peer assessment.
If necessary, a focused surveillance assessment visit is conducted.
(See “The Surveillance Assessment Visit”).
Assessment
Visit Notification
Laboratories receive written
notification (120 days) of each pending peer accreditation assessment
visit and self-assessment. This includes reassessment visits and
focused surveillance visits. (See “The Reassessment Visit” and
“The Surveillance Visit”). The initial notification is sent to the
designated correspondent of the laboratory and the official laboratory
director(s). OLA staff and directors set mutually agreeable dates for
the visit. Laboratories receive the names of all team members prior to
visits and have the opportunity to reject a member based on defined
conflict of interest guidelines.
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