The Ontario Laboratory Accreditation (OLA) program was implemented in 2003, and to date 114 of Ontario’s 242 licensed laboratories have been assessed. During a peer assessment visit, a team of assessors seeks to confirm that laboratories conform to the OLA requirements, which are based on the ISO 15189:2003 standard known as CAN/CSA Z-15189-03 Medical laboratories—Particular requirements for quality and competence. At the conclusion of the assessment, the team provides a verbal summary of their findings, including all major and minor non-conformances assessed. Within 30 days of the assessment, the laboratory receives a final, written summary report that details all non-conformances. A laboratory has 90 days from the assessment in which to submit corrective actions planned or implemented to satisfactorily address all non-conformances. The OLA staff coordinator attending the assessment, team leader, OLA Advisory Panel and OLA Director, review corrective actions submitted by laboratories.

The purpose of this article is to explain, in detail, QMP–LS’ expectations for corrective actions submitted to OLA following peer assessment visits.

The reason corrective actions must be submitted to QMP–LS following a peer assessment visit is simple—a laboratory must demonstrate that within 90 days of the peer assessment visit, all non-conformances are resolved or action plans are implemented to address them. QMP–LS provides a Microsoft Excel spreadsheet to facilitate the submission of corrective actions, via the secure, password-protected Document Server of the QMP–LS Web site. Action plans must include detailed implementation steps, the name of the individual(s) responsible and timelines for completion. A description of the corrective action must be provided on this spreadsheet, along with documentation to substantiate it. Acceptable supporting documentation may include approved policies, processes and procedures, records providing evidence of implementation, meeting minutes, receipts of equipment purchase, installation and verification records, completed forms and patient reports (with patient identification removed, photographs, etc). When all major non-conformances are resolved and action plans to address minor non-conformances are acceptable, QMP–LS issues an accreditation certificate. The following is a step-by-step guide explaining what information QMP–LS is looking for.

For each non-conformance, the laboratory should determine the extent of the problem considering all areas of the laboratory, not just the area where the non-conformance was cited.

The investigation and follow-up of non-conformances is a critical component of an effective quality management system. Laboratories should strive to follow their own process for the investigation of non-conformities and to use the procedures and related forms they have created for this purpose. The QMP–LS corrective action form is not intended to replace a laboratory’s own process for quality improvement, rather, it is a means to facilitate communication.

QMP–LS provides laboratories with an electronic corrective action form for the purpose of explaining the corrective action(s) taken to address non-conformances. In the case of assessments involving multiple laboratory sites, a separate form is provided for each. All non-conformances listed on the summary report will appear on the form.

l	Laboratories are instructed to complete the columns labelled "Corrective Action" and "Date of Completion," to provide a contact name and telephone number and to have the completed form signed by both the Laboratory Director and the CEO/President of the Organization.
l	The completed form is submitted to QMP–LS in electronic format. Evidence to substantiate the corrective actions explained on the form may be submitted by embedding electronic documents and records into the spreadsheet itself, or by submitting them separately by e-mail, fax or regular mail (CD-ROM or hard copy).

The supporting evidence to substantiate claims made on the corrective action form is the most important component of the laboratory submission. It must provide conclusive evidence that actions taken or planned are sufficient and effective.

For each major non-conformance the laboratory must provide supporting documentation that substantiates successful correction of the issue. The type of documentation will vary according to the nature of the non-conformance. Acceptable supporting documentation may include:

For minor non-conformances, QMP–LS requests documentation that substantiates correction of the minor (as described above) or a detailed action plan. Action plans must include:

It is enormously helpful if all documentation is embedded in the spreadsheet, organized into a binder, or burned onto a CD-ROM. Each document must be labelled with the non-conformance number and the QMP–LS laboratory code number. In the case of an assessment involving multiple laboratory sites, the laboratory should prepare a separate submission for each laboratory license number.

On receipt of the corrective action form and supporting evidence, the OLA coordinator, team leader, one OLA Advisory Panel member and OLA Director conduct an initial review. The goal of the review is to determine if:

OLA staff will correspond with the laboratory if further clarification/documentation is needed to provide confidence in the corrective actions taken. When further information is requested, a deadline is provided to the laboratory (usually two weeks). In some cases, additional clarification will be needed but, the total time-frame allowed for seeking clarification and additional documentation from the facility is 45–60 days. Following the receipt of follow-up information and documentation, if any one of the reviewers believes that any major non-conformance is not corrected, the OLA Advisory Panel conducts an extensive review. On completion of the review process, three options may result (see Table 1):

 
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