Thursday, April 28, 2005

Evaluation of Medical Laboratory Conformance to ISO 15189:2003: The Ontario, Canada Experience

Linda Crawford and Harold Richardson.

The Quality Management Program Laboratory Services provides mandatory accreditation for 248 laboratories in Ontario, Canada through its Ontario Laboratory Accreditation (OLA) program. Requirements for accreditation are based on ISO 15189:2003, Medical laboratories particular requirements for quality and competence.

To be the first North American accreditation authority to assess conformance to ISO 15189:2003.

Laboratories receive OLA requirements (which are based on ISO 15189:2003, applicable legislation and generally accepted principles of good practice) along with guidance information on their application to medical laboratory practice. Prior to peer assessment, laboratories conduct self-assessments and those reports are available to the team for comparison with peer assessment findings. During the peer assessment visit, conformance to requirements is assessed through observing practice, interviewing staff, and reviewing documentation. Non-conformances are classified as either major or minor in nature. Laboratories have 3 months to correct all majors and initiate satisfactory corrective action for all minors. When this is confirmed, 5-year accreditation certificates are issued. If majors have not been corrected but a satisfactory action plan is in place, 2-year certificates are issued.

Based on 61 peer assessments, conformance ranged from 79 to 100% with an average of 93%. No laboratory has failed to achieve accreditation. Thirty-four 5-year and seven 2-year certificates have been issued. Per assessment, between 0 and 47 major non-conformances and 0 and 95 minor non-conformances were assessed. Average conformance is highest to requirements for laboratory information systems (96%), organizational structure, personnel policies and laboratory management (96%), and safety (95%). Conformance is poorest to requirements for analytical processes (average 77%). Of 551 requirements, only two have not been met by more than 50% of laboratories assessed.

Ontario is the only North American accreditation authority to assess laboratories against ISO 15189:2003. To date, laboratories demonstrate that they can meet this rigorous international standard.

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