Overview

OLA’s assessment process uses peer volunteers to ensure that laboratories meet explicit quality management criteria, in order to provide formal recognition that the laboratory is competent to carry out examinations. Standards for accreditation are identified in advance. OLA’s accreditation requirements translate the standards into explicit criteria for accreditation. Accreditation assessment visits determine if laboratories conform to requirements, for all examinations performed for diagnosis, prophylaxis and treatment of humans. Applicant laboratories designate the applicable scope under assessment. Ongoing surveillance (e.g. self assessment, PT/EQA monitoring) ensures that accredited laboratories continue to meet the requirements for accreditation. In Ontario and Newfoundland & Labrador, all activities and all premises associated with the scope of testing proposed for accreditation (classes of tests), are subject to accreditation assessment.

Agreement with Standards Council of Canada

In August 2005, an agreement was signed with the Standards Council of Canada (SCC) for the joint delivery of a national program for medical laboratory accreditation outside of Quebec. Under this agreement, SCC will impart national recognition of conformance and issue an accreditation certificate to ISO 15189. ISO 15189:2007 Medical laboratories – Particular requirements for quality and competence, which is also available from SCC as CAN-P-11. (See “Partnership with Standards Council of Canada”).

A licensed Ontario medical laboratory wishing to have the SCC issue it an ISO 15189 certificate needs to inform QMP–LS when notified of its pending accreditation assessment visit. Additional conditions and fees will apply.

Eligibility

OLA accreditation is mandated for medical laboratories in Ontario and Newfoundland & Labrador. Medical laboratories from other jurisdictions in Canada and other countries are eligible to voluntarily apply for accreditation as long as applicants agree to the following conditions for attaining and maintaining accreditation:

1. Cooperate as is necessary to enable OLA to verify conformance with the requirements for accreditation. This includes providing access to information, documents and records as necessary for determination of impartiality, assessment and maintenance of accreditation. It also includes arranging witnessing of services during assessment.

2. Comply at all times with the criteria, requirements (including participation in proficiency testing as required), and conditions for accreditation.

3. Authorize full exchange of laboratory and assessment information between QMP–LS and SCC, for the purpose of granting accreditation. Claim accreditation only in respect to the testing scope accompanying the certificate, which pertains to the scope of assessment.

4. Pay such fees as shall be determined by OLA and SCC. Costs associated with assessments are variable depending on the scope of assessment and the travel needs of the team members.

5. Not use its accreditation in such a manner as to bring OLA or SCC into disrepute and not make any statement relevant to its accreditation which OLA may consider misleading or unauthorized.

6. Upon suspension, withdrawal or expiration of its accreditation, discontinue its use of all advertising matter that refers to the accreditation status, and when requested, return any certificates of accreditation.

7. Inform OLA without delay and in writing of changes or pending changes in the:

• legal, commercial, ownership or organizational status;

• organization, top management or key personnel;

• main policies;

• resources and premises;

• testing scope; and

• miscellaneous matters that may affect the ability to fulfill accreditation requirements.