|
Information About
the Accreditation Process
Introduction
OLA is operated by QMP–LS and is funded by Ontario’s Ministry of Health and Long-Term Care. OLA is mandatory for all licensed Ontario medical laboratories and others may subscribe voluntarily.
Definition
Accreditation is a peer review assessment process by which an authoritative body ensures 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.
Accreditation requirements translate the standards into explicit criteria for accreditation. Assessments determine if laboratories conform to requirements, for all examinations performed for diagnosis, prophylaxis and treatment of humans. All activities and all premises associated with the scope of testing proposed for accreditation, are subject to 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. Under this option, accreditation certificates will be signed by the SCC and will impart national recognition of conformance to the quality management principles in ISO 15189:2003 Medical laboratories – Particular requirements for quality and competence, which is also a Canadian national standard and is available as CAN/CSA Z15189-03.
Conditions for Accreditation
To attain and maintain accreditation, an applicant must agree to:
-
Cooperate as is necessary to enable QMP–LS 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.
-
Comply at all times with the criteria, requirements (including participation in proficiency testing as required), and conditions for accreditation.
-
Claim accreditation only in respect to the testing scope accompanying the certificate, which pertains to the scope of assessment.
-
Pay such fees as shall be determined by QMP–LS. Costs associated with assessments are variable depending on the scope of assessment and the travel needs of the team members.
-
Not use its accreditation in such a manner as to bring QMP–LS into disrepute and not make any statement relevant to its accreditation which QMP–LS may consider misleading or unauthorized.
-
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 to
QMP–LS.
-
Inform QMP–LS 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
Program
Information (Voluntary Participants)
|
