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A
formal report of the accreditation assessment visit is issued to the
recipient facility within 14 days of the accreditation assessment visit,
with a spreadsheet on which the laboratory may submit any corrective action.
It summarizes conformance and provides commentary to explain all incidences
of non-conformance with the program requirements. Within two weeks of its
receipt, the facility may dispute findings based on errors of fact.
Non-conformances are
classified as either minor or major. (See “Decision-making and Granting
Accreditation” for an explanation of their significance).
Minor
non-conformance
-
Isolated
incident of non-conformance or
-
Adherence to
procedures is inconsistent (usually followed but sometimes not) or
-
Existing
protocols address requirement but are not necessarily followed.
Major
non-conformance
-
Requirement not
addressed by laboratory’s quality manual or operating procedures or
-
Procedures are
consistently NOT followed or
-
Existing
protocols fail to address requirement or
-
Non-conformance
directly impacts patient safety or
-
Consistent/persistent
incidence of non-conformance or
-
Repeated
incidence of non-conformance in the majority of sections of the
laboratory.
Corrective
Action
The
facility must submit corrective actions to QMP–LS with supporting
documentation within 90 days of the accreditation assessment visit. QMP–LS
reviews the corrective actions and corresponds with laboratory staff if
further clarification/documentation is required. Laboratory corrective
action documentation is shared with the staff coordinator, team leader and
OLA Advisory Panel. The appropriate QMP–LS Scientific Committee(s) may be
consulted for advice and determination of satisfaction in addressing
outstanding technical issues
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Revised: 2008-10-07
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