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Categories
How does Ontario’s program compare to the rest of Canada and the world?
Who does OLA accredit?
Who are the assessors?
Will my laboratory know when an accreditation assessment visit will occur and who is coming?
An accreditation assessment visit every five years does not seem often enough. Will this ensure the quality of laboratories remains high?
Where can I find examples of conforming policies,
processes, procedures and documentation?
Can multiple sites be accredited simultaneously?
If my laboratory is ISO 9001:2000 registered, will we automatically receive full accreditation?
We have been accredited by the College of American Pathologists (CAP) through their Laboratory Accreditation Program (LAP). Do we automatically receive full Ontario
Accreditation?
Does our laboratory have to pay for
accreditation?
How do the current on-site consultations from QMP–LS fit in?
What about inspections conducted by
MOHLTC?
Are OLA accreditation requirements based on ISO
15189?
Why do small rural labs need to meet the same requirements as large teaching hospitals?
Is OLA open to suggestions for changes to the requirements?
How will updates to the requirements be communicated to laboratories?
Who will receive the correspondence for the peer assessment?
Who sets up a peer assessment visit?
How does Ontario’s program compare to the rest of Canada and the world?
OLA development began with global research into programs of this type. (Programs within Canada, Australia, the United Kingdom and the United States were studied). Our program
incorporates suggested elements and other unique features to achieve the most effective and efficient means of accreditation assessment within Ontario.
Who does OLA accredit?
OLA is mandatory for all medical laboratories licensed by the Ontario
Ministry of Health and Long-Term Care, and may be subscribed to by others.
Who are the assessors?
Accreditation teams consist of a team leader, an OLA staff technologist, and sufficient assessors to provide expert coverage for all disciplines involved.
Professionals trained in medical laboratory science with working knowledge
of clinical laboratory practice will serve as accreditation assessors. Peers with broad knowledge of laboratory operations and quality assurance practices
— and those who possess management skills or specialty expertise are selected. All assessors receive training and orientation. Assessors find this a rewarding
experience and participation is a recognized quality assessment
activity. Each laboratory benefits when its staff members serve as
assessors because these people possess the skills to conduct internal
audits and self-assessments.
Will my laboratory know when an accreditation assessment visit will occur and who is coming?
Yes, laboratories are notified of a pending peer assessment visit.
Visits are scheduled in consultation with the laboratory. The laboratory knows in advance who the team members are. Every possible attempt
is made to avoid conflicts.
An accreditation assessment visit every five years does not seem often enough. Will this ensure the quality of laboratories remains high?
Laboratories are expected to conduct an extensive self-assessment midway through their accreditation cycle. A summary report will be submitted to
QMP–LS, and the accreditation team will review detailed documentation of this assessment during the next scheduled accreditation assessment visit.
EQA will continue as usual through which laboratories are continuously monitored for
test performance. In addition, the accreditation requirements themselves ensure that a laboratory’s Quality Management System is functioning to a high standard. Regular participation in quality improvement programs, the use of quality indicators, regular audits with follow-up, and effective document control are all essential elements.
The frequency of other accreditation programs varies from two to six years and may
or may not include interim external surveillance and/or mandatory
internal audits.
Where can I find examples of conforming policies,
processes, procedures and documentation?
Samples shared by
laboratories are posted on our document server.
Can multiple sites be accredited simultaneously?
As the restructured regional laboratory services develop, OLA will be able to schedule
peer assessment visits with optimal efficiency. Multi-site laboratory
visits are possible.
If my laboratory is ISO 9001:2000 registered, will we automatically receive full accreditation?
ISO 9001:2000 will not replace the accreditation assessment or automatically ensure full accreditation. ISO 9001:2000 registration will go a long way in ensuring that a laboratory meets the OLA quality system requirements. However, accreditation criteria
are based on the more comprehensive and process-oriented OLA requirements.
We have been accredited by the College of American Pathologists (CAP) through their Laboratory Accreditation Program (LAP). Do we automatically receive full Ontario
Accreditation?
We recognize that the CAP program is comprehensive and rigorous. While CAP accreditation will help participants prepare for Ontario accreditation assessment, LAP certification will not automatically ensure full OLA certification. Participation in OLA’s peer accreditation process and demonstration of full
conformance to its requirements will be necessary for all Ontario
laboratories. Where equivalency can be established, assessment will not be
duplicated.
Does our laboratory have to pay for
accreditation?
At this time, costs associated with a regularly scheduled peer assessment visit
every five years are paid for by MOHLTC, through the QMP–LS operating budget. However, if an accreditation
certificate expires in two years, costs associated with
follow-up peer
assessment visits (e.g., assessors' travel and honoraria) conducted in two
years' time may be billed to the recipient laboratory.
How do the current on-site consultations from QMP–LS fit in?
QMP–LS will continue to operate its external quality assessment
(EQA) program. If a laboratory’s performance exhibits cause for concern, the file will be monitored and the EQA committee may recommend an
on-site consultation. These consultations have a different focus than
accreditation assessment visits because they focus on process outcomes.
What about inspections conducted by
MOHLTC?
Over the implementation of the accreditation program, the
inspection process will continue. QMP–LS and MOHLTC will work closely
together to ensure that the two processes are complimentary to avoid
duplication and to ensure that there is an appropriate level of oversight.
Are OLA accreditation requirements based on ISO
15189?
ISO 15189 “Medical Laboratories—Particular Requirements for Quality and Competence.” Canadians Harold Richardson, Andrew Grant, Maurice Dupras and Michael Noble participated in its creation, by serving on the international working group responsible for that process. OLA’s accreditation requirements are largely based on this
document.
Why do small rural labs need to meet the same requirements as large teaching hospitals?
All residents of Ontario deserve the same high standards, regardless of their location. We recognize that some of the criteria may be more difficult for small laboratories to meet while others will be easier for a small laboratory to implement. We attempted to recognize the unique aspects of hospital, private, community and academic providers in drafting the requirements. In many cases they allow the provider to determine what is appropriate.
Is OLA open to suggestions for changes to the requirements?
Yes, absolutely. Although the Accreditation Advisory Panel and other expert advisors extensively reviewed the
program requirements and operating priniciples, we recognize that further changes are inevitable.
OLA staff review all requirements on a bi-annual basis to determine if
they are reasonable and achievable. Referenced standards, guidelines and legislation
are updated regularly. In addition, any requirement can be challenged following an accreditation assessment visit. The Advisory Panel will investigate all challenges and may recommend changes to the requirements.
These changes will be shared with participating laboratories.
How will updates to the requirements be communicated to laboratories?
Updates will be communicated via QMP–LS News, the QMP–LS
Web site, and an electronic workspace that can be accessed over the Internet. The electronic workspace
includes a secure directory where files can be shared.
Who will receive the correspondence for the peer
assessment?
Notification letters are sent to the official Designated Correspondent for the Owner/operator and the official Laboratory Director(s) as named on your laboratory license.
Who sets up a peer assessment visit?
The OLA staff coordinator will telephone the laboratory to determine who is designated to coordinate the visit within the facility.
Questions
about the OLA
Requirements
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