Quality
Manual Review
Notification of an
upcoming peer assessment visit includes a self-assessment form for the
laboratory quality manual. The completed form is returned to QMP–LS with a
copy of the quality manual. The quality manual is returned during the
accreditation assessment visit.
Accreditation
Team Members
Accreditation
assessment teams consist of a team leader, an OLA staff technologist, and
additional assessors as dictated by the size and scope of the laboratory.
Teams are balanced to include physicians, scientists and medical laboratory
technologists and to provide expert coverage for all disciplines involved.
Teams include peers with the knowledge of laboratory operations and quality
assurance practices, and who possess management skills and specialty
technical expertise. All assessors receive advance training and
certification.
Training, certification
and recertification of assessors are based on the following seven
competencies.
-
Familiarity
with the OLA Requirements and Guidance Information and values
-
Knowledge
of the accreditation assessment process and procedures
-
General
knowledge of quality management systems
-
Specific
laboratory knowledge of the appropriate disciplines
-
Assessment
information gathering techniques
-
Ability
to identify, record and classify the degree of conformance to the OLA
Requirements
-
Interpersonal
skills to conduct assessments according to OLA values
The
Accreditation Assessment Visit
The team leader
conducts an opening meeting with laboratory staff to review the
accreditation assessment visit purpose and agenda. Accreditation team
members assess the laboratory according to pre-assigned tasks and each
member completes the appropriate assessment tools (checklists) to determine
conformance to program requirements. This process is detailed and
comprehensive. At the conclusion of the visit, the team leader facilitates a
summation meeting to review the findings and conclusions with
administration, laboratory management and additional laboratory staff
included by laboratory management. This verbal report outlines commendations
and major/minor non-conformances.
Multi-site corporations
may quality for a single assessment, in which the application of shared
management services and the quality management system are verified at each
site. Some conditions apply to address travel and duration of the visit(s).
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Revised: 2008-10-07
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