There are three requirements related to comparability studies in section VII of the IQMH Accreditation Requirements and Guidance Information.
The IQMH Consensus Practice Recommendations on Laboratory Investigation of Malarial Parasites was recently revised in December 2015 (available in QView™ under General – Proficiency Testing, PT Guidelines and Recommendations, Hematology). The most significant change to this document is the recommendation to report the parasitemia level as a per cent (%). Although the parasitemia level is not a precise measurement, it provides useful information to the clinician as a measure of the severity of the disease and to monitor effectiveness of therapy.
In order to elevate confidence in the effective implementation of corrective actions, the Center for Accreditation has enhanced the Ontario self-assessment process. At present, participants in the mandatory program in Ontario are visited once every four years and submit a self-assessment mid-cycle as a surveillance activity. On notification of self-assessment, laboratories are provided the Self Assessment Master Checklist and Assessment Visit Follow-Up Report forms on which to report an update on progress made to address non-conformances cited on the last assessment visit. These forms are located in the facility’s secure QView™ site.
Licensed laboratories in Ontario are reminded that, in Ontario, IQMH operates two streams of accreditation: the mandatory IQMH accreditation program and the ISO 15189 Plus™ program. The two programs differ only in the frequency of assessment. The mandatory stream consists of a full accreditation assessment every four years, the ISO 15189 Plus™ stream includes a mid-cycle surveillance visit conducted by IQMH. The table below summarizes the two streams:
Point-of-care (POC) compliance evaluation, whether for internal audit or IQMH accreditation assessment, is very challenging when there are different POC analytes and devices throughout a facility or multiple facilities.
Since the completion of the original Human Genome Project using Sanger sequencing in 2001, there have been many advances in sequencing technologies. Most recently, the invention of Next Generation Sequencing (NGS) is allowing laboratories to use whole genome sequencing in a clinical application.1 Today, there are many different platforms to perform NGS and competition between companies has lowered the cost of this application.1 The incorporation of this type of testing into the diagnostic world will be one of the main contributions to providing personalized, unique healthcare to patients.1
Since December 2013, IQMH Centre for Accreditation has been assessing laboratories against the newest version of the requirements, Version 6.0.
Listed below are the top five non-conformances generated from March 2014 to present.
Institute for Quality
Management in Healthcare
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