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The
Reassessment Visit
Following the initial
accreditation assessment visit and issue of a full accreditation certificate,
subsequent assessments will occur to renew accreditation. This regularly
scheduled subsequent assessment is called a “reassessment visit.”
The
Surveillance Assessment Visit
The surveillance
assessment visit (focused) occurs one year after the initial issue of an ISO
15189 certificate by SCC, and otherwise may be initiated upon:
-
New
laboratory ownership or laboratory address
-
Reinstatement
of a Ontario laboratory previously declared non-proficient by Conjoint Committee
-
Request
due to a potential threat to patient safety (from the facility or
government regulator)
-
Addition
of a class of tests to the test menu
-
Self-assessment
findings that demonstrate no intent to implement corrective actions or
that raise other concerns regarding patient care
-
Imminent
expiry of a 2-year certificate
Surveillance assessment
visits will occur within six months of the change or request. The direct costs
associated with a surveillance assessment visit will be billed to the
laboratory (some exceptions apply).
For voluntary
accreditation laboratories, a surveillance assessment visit (focused) may
occur
to verify self-assessment findings submitted two years following the
accreditation assessment, and the laboratory is invoiced for costs.
PT/EQA
Surveillance
Participation in and
performance on proficiency testing (external quality assessment) is monitored
on an on-going basis. Laboratories holding accreditation certificates must
participate in formal inter-laboratory comparison schemes, where available and
appropriate, for all examinations included in the scope of accreditation.
Formal inter-laboratory
comparison (PT/EQA) schemes that are acceptable to QMP–LS meet these
criteria:
Formal inter-laboratory comparison programs shall offer at least two surveys
per year, and each survey shall contain at least two samples, and there must
be tangible evidence of performance evaluation.
Formal programs known to
QMP–LS that meet the above criteria are published on the QMP-LS Web site
(see "Accredited Laboratories"). Additional programs that meet these criteria should be submitted at
ola@qmpls.org
and will be added to the list.
Laboratories holding
accreditation certificates must provide QMP–LS with evidence of
participation and satisfactory performance in PT/EQA programs from other
providers, as part of ongoing surveillance. Beginning October 2008, this
information is submitted using the QView Web data-entry application.
Satisfactory performance
is defined as acceptable results on the majority of vials in a single survey.
Over time, satisfactory performance is defined by satisfactory performance in
at least two out of three surveys.
When
formal inter-laboratory comparison programs are not available, accredited
laboratories are expected to find an alternative such as split sample testing.
The alternative shall occur at least twice per year with a minimum of two
samples each time. Examples of alternatives can be obtained in the following
Clinical Laboratory Standards Institute document: Assessment of Laboratory
Tests when Proficiency Testing is Not Available; Approved Guideline, NCCLS
Document GP29-A December 2002.
Laboratories must also demonstrate that
corrective actions identified through these activities are carried out when
necessary.
The
Self-assessment
Self-assessments are
intended to assist laboratories in determining the degree to which they meet
accreditation requirements. Self-assessments ensure that:
1.
Laboratories continue to monitor their own conformance to accreditation
requirements.
2.
QMP–LS can identify the degree to which
laboratories meet requirements and monitor corrective action plans
3.
QMP–LS can determine requirements that may be difficult to achieve.
OLA formally coordinates
the self-assessment process by requiring that laboratories perform self
assessments and report their findings in exception reports. Ongoing follow-up
to address non-conformances assessed at the last accreditation assessment must
also be reported. Detailed instructions and a customized checklist are
provided with the 120-day notification. Self-assessment exception reports are
reviewed at QMP–LS. Following review, laboratories receive correspondence
that confirms receipt of reports and provides a summary of conformance.
For voluntary accreditation, a focused
surveillance assessment visit may be conducted to verify the findings. Submitted
reports are retained in accreditation files, and details of self-assessments
are reviewed during the next scheduled accreditation assessment visits.
The
Surveillance Questionnaire
A surveillance questionnaire is
sent to laboratories issued an ISO 15189 certificate by SCC on the years when
there is no self-assessment or surveillance assessment visit.
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Revised: 2008-10-07
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