Institute for Quality Management in Healthcare (IQMH) Toronto, Ontario, Canada Janice Nolan, Executive Director, Programs
Thank you! Thank you for inviting me My pleasure to share with you our experience with implementation of an accreditation program to ISO 15189 for medical laboratories 2017-08-24 Institute for Quality Management in Healthcare 2
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Institute for Quality Management in Healthcare (IQMH) Vision IQMH will be the Standard for Confidence in accreditation, proficiency testing and education services within the international medical diagnostic testing community. Mission Elevating confidence in the system. To elevate the integrity of the medical diagnostic testing system by providing rigorous, objective, third-party evaluation according to international standards. 2017-08-24 Institute for Quality Management in Healthcare 4
Healthcare funding in Canada Canada s healthcare system is publically funded and provides universal coverage for medically necessary healthcare The provinces are responsible for establishing, maintaining and managing hospitals and other social services The federal government reimburses money to the provinces The provinces each manage laboratories differently 2017-08-24 Institute for Quality Management in Healthcare 5
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Institute for Quality Management in Healthcare (IQMH) Proficiency testing program for Ontario since 1974 Mandatory accreditation program for: Ontario licensed medical laboratories since 2002 Newfoundland & Labrador medical laboratories since 2011 New Brunswick medical laboratories since 2013 Ontario licensed specimen collection centres since 2017 Voluntary accreditation program for: 3 laboratories in British Columbia, 1 in Nova Scotia, 1 in Trinidad, 1 in Senegal Education that supports accreditation and proficiency testing programs 2017-08-24 Institute for Quality Management in Healthcare 7
Mandatory accreditation program for Ontario licensed medical laboratories Requirements based on ISO 15189 but with a selfassessment at mid-cycle ~30% of Ontario medical laboratories have voluntarily upgraded to ISO 15189 program On-site surveillance visit at mid-cycle 2017-08-24 Institute for Quality Management in Healthcare 8
IQMH Centre for Accreditation IQMH expertise is in the delivery of an accreditation program to ISO 15189 Third party assessments must be carried out according to strict criteria in order to be impartial and reputable IQMH does not write consensus standards. Our role is to evaluate conformance to proven standards and to award recognition of that conformance 2017-08-24 Institute for Quality Management in Healthcare 9
IQMH Centre for Accreditation Internationally recognized as competent to evaluate diagnostic services. Accredited to ISO 17011 Conformity assessment Requirements for accreditation bodies accrediting conformity assessment bodies 2017-08-24 Institute for Quality Management in Healthcare 10
IQMH Requirements ISO 15189:2012 Medical Laboratories Requirements for Quality and Competence ISO 15190:2003 Medical Laboratories Requirements for Safety ISO 22870:2006 Point-of-care Testing (POCT) Requirements for Quality and Competence These standards are cross-referenced to generally accepted principles of good practice appropriate to the jurisdiction. Additional references include Canadian and provincial legislation, and existing international, national and regional guidelines developed by consensus. CSA Standard Z902-15 Blood and Blood Components December 2015 2017-08-24 Institute for Quality Management in Healthcare 11
IQMH Requirements for Medical Laboratory I. Organization, Personnel & Management II. Quality Management System III. Physical Facilities IV. Equipment, Reagent and Supplies V. Pre-examination Process VI. Examination Process VII. Quality Assurance of Laboratory Examinations VIII. Post-examination Process [Reporting] IX. Laboratory Information System X. Safety XI. Point-of-care Testing 2017-08-24 Institute for Quality Management in Healthcare 12
Additional Technical Requirements Discipline Specific Requirements Chemistry 9 Cytogenetics 41 Cytopathology 32 Flow Cytometry 27 Hematology 28 Microbiology 36 Molecular Diagnostics 32 Maternal Serum Screening 10 Anatomic Pathology 30 Transfusion Medicine 110 2017-08-24 Institute for Quality Management in Healthcare 13
IQMH laboratory accreditation experience 15 years 3 ISO standards and additional technical 466 requirements 287 clients ~250 trained peer assessors New voluntary program for Diagnostic Imaging services, Point of Care Testing and Specimen Procurement facilities 2017-08-24 Institute for Quality Management in Healthcare 14
Peer Assessment Team Volunteer peer technical assessors trained by IQMH Work within the industry knowledgeable in their area Assessment teams contain experts in all areas covered under the scope of accreditation Provided with briefing material prior to the assessment via portal Use requirement checklists ipad with assessor software Interview staff, observe practices, review evidence Team Leader with each team IQMH Staff Technologist coordinates all aspects of the visit and accompanies the team 2017-08-24 Institute for Quality Management in Healthcare 15
IQMH Centre for Accreditation Values Responsible Objective Consistent Transparent Open-minded Respectful 2017-08-24 Institute for Quality Management in Healthcare 16
Essential Elements of Accreditation Program Known management & technical standards Advance notice (4 year cycle) Peer-to-peer, on-site assessment Non-conformances categorized as major or minor Corrective action allowed Certificate issued for scope of testing Surveillance (on-site visit and Proficiency Testing/External Quality Assessment) Evaluation and feedback for continual improvement Supported by Accreditation Advisory Panel Includes representatives from provinces 2017-08-24 Institute for Quality Management in Healthcare 17
Accreditation assesses Compliance with management system standards that ensures consistent and efficient services Competence of staff Integrity and traceability of equipment and materials Technical validity of methods Validity and suitability of results 2017-08-24 Institute for Quality Management in Healthcare 18
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Benefits of Accreditation Program Implementation of an ISO Quality Management System The biggest benefit will be the standardization of processes and the implementation of tools to measure the effectiveness of processes. Fosters a culture of continuous quality improvement. 2017-08-24 Institute for Quality Management in Healthcare 20
Benefits of Accreditation Program Assurance of Technical Competence Accreditation will elevate the confidence of patients, users of the services, administration, government and staff 2017-08-24 Institute for Quality Management in Healthcare 21
Benefits of Accreditation Program Risk Reduction The identification and mitigation of risk is a major component of the program. Increase awareness of risk Focus efforts on issues that matter most Create a culture of prevention Increase success 2017-08-24 Institute for Quality Management in Healthcare 22
Benefits of Accreditation Program Staff confidence and professional development Meeting the accreditation requirements will open up interest and engagement in quality management. 2017-08-24 Institute for Quality Management in Healthcare 23
Benefits of Accreditation Program Demonstrates a commitment to quality and accountability 2017-08-24 Institute for Quality Management in Healthcare 24
Benefits of Accreditation Program Cultivation of Fresh Ideas Assessors involved in the IQMH program see many different facilities and solutions to common problems. 2017-08-24 Institute for Quality Management in Healthcare 25
Benefits of Accreditation Program Loss of Isolation Laboratory managers will frequently work with other facilities to meet the more difficult requirements. 2017-08-24 Institute for Quality Management in Healthcare 26
Mandatory versus Voluntary program Consistency between assessment teams Sustainability and maintenance of a quality management system 2017-08-24 Institute for Quality Management in Healthcare 27
Not Just About Meeting the Standards It is about: Self-correcting Internal responsibility and internal reporting 2017-08-24 Institute for Quality Management in Healthcare 28
Benefits to the Patient Assurance of quality, standardization, consistency in care Happy and satisfied staff Confidence in the health care system 2017-08-24 Institute for Quality Management in Healthcare 29
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THANK YOU! jnolan@iqmh.org 2017-08-24 Institute for Quality Management in Healthcare 32