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IN THIS ISSUE |
No. 128 July 2008 |
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Eye on OLA: The Accreditation Cycle Repeats Itself 4th Annual McMaster Update in Thromboembolism Mycology Questionnaire QMP–LS policy on confidentiality, conflict of interest and privacy Workshop: Seeing your Lab through a "Lean" Eye
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Important changes to Ontario Laboratory Accreditation: Version 4.1 (July 2008) of accreditation Requirements released by Linda Crawford and Christine Fry On July 1, 2008, QMP–LS released Version 4.1 (V4.1) of its Ontario Laboratory Accreditation Requirements. This is an update of Version 4 (December 2007), which was released in January 2008. As with all changes to accreditation requirements contained in Version 4, these updates will be in effect for all assessment visits occurring after September 1, 2008 and for all self-assessments due after September 1, 2008. Also of note, certificates awarded based on V4.1 of the Ontario Laboratory Accreditation Requirements will be valid for a period of up to four years. If, however, outstanding major non-conformances cannot be resolved but the laboratory demonstrates satisfactory corrective action plans, a two-year certificate will be issued. Self-assessments will continue to be due at the midpoint of the cycle—two years following the date of your last assessment visit. Why did OLA release Version 4.1 of its Accreditation Requirements? When a change occurs in law (statutes and regulations) or other government directive that will affect the wording and intent of a requirement, OLA must update its requirements for accreditation by releasing a sub-version. A regulation amendment has been made to Ontario Regulation 682, Laboratory and Specimen Collection Centre Licensing Act, R.S.O. 1990, c.L.1 regarding the reporting of all positive presumptive or reportable diseases. This regulation amendment reflects the changes made to the Health Protection and Promotion Act in the Health System Improvements Act, 2007. Effective April 1, 2008, laboratories must report all positive findings that indicate the presumptive presence or presence of any reportable disease to the medical officer of health of the health unit "in which the person who gives rise to the case resides." Laboratories were previously required to report positive findings to the medical officer of health of the health unit in which the laboratory was located. The intent of this amendment is to streamline the overall reporting process and lead to faster notification of a reportable disease to the appropriate medical officer of health. Version 4.1 (July 2008) of the Ontario Laboratory Accreditation Requirements and Guidance Information reflects this change—the content of requirements VIII.12.1 and VIII.12.2 are revised and combined to reflect this change. An opportunity seized With the need to release a Version 4.1 to comply with changes in regulation, QMP–LS seized the opportunity to make additional changes to individual requirements as well as to update references. Changes of note are show in the following table:
The table below compares the number of Requirements and Good Practice Recommendations in the previous Version 4 to the latest Version 4.1.
There have also been
some changes to the discipline specific information for Molecular
Diagnostics and Cytogenetics. Seven pieces of Molecular Diagnostic
guidance that relate specifically to inherited disorders have been removed
and renamed under the Cytogenetics guidance. Cytogenetics will be renamed
to more appropriately capture its contents The references have been revised to be reflective of the updates as described above. Of particular interest, the Canadian Standards Association has been instructed by the Standards Council of Canada (SCC) to withdraw CAN/CSA-Z15189-03. The new edition of ISO 15189-07 has been adopted by the SCC as CAN-P-11. CAN-P-11 is identical in content to ISO 15189:2007(E) Medical Laboratories—Particular Requirements for Quality and Competence. CAN/CSA-Z15189-03 has been removed from our references for V4.1 of the Requirements and Guidance Information. When does V4.1 take effect? All laboratories notified of a pending peer or self-assessment to be completed after September 1, 2008 will be assessed using Version 4.1. If you have been notified and received a checklist for Version 4, QMP–LS will re-issue your notification with a checklist for Version 4.1. How do we access V4.1? Version 4.1 of the Ontario Laboratory Accreditation Requirements, Guidance Information and References is available at www.qmpls.org through the password-protected QView™. Each participating laboratory and stakeholder may use the username and password it was previously provided by QMP–LS. The files will become available on July 1, 2008. Summary To summarize, beginning September 2008, all assessments will be conducted against Version 4.1 (July 2008) of the OLA Requirements and Guidance Information. Laboratories that correct all major non-conformances and submit satisfactory corrective action plans for all minor non-conformances will receive 4-year accreditation certificates. Any laboratory that is unable to resolve all major and minor non-conformances, but who submits satisfactory corrective action plans, will receive a 2-year certificate. Prior to the expiry of a 2-year certificate, a laboratory may apply to have its 2-year certificate extended a further two years if it provides evidence that any outstanding major non-conformances have been corrected. |
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