institute for quality management in healthcare (iqmh ... · pdf file•sustainability and...

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 2Institute for Quality Management in Healthcare

2017-08-24 Institute for Quality Management in Healthcare 3

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.


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


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


• Mandatory accreditation program for Ontario licensed medical laboratories

• Requirements based on ISO 15189 but with a self-assessment at mid-cycle

• ~30% of Ontario medical laboratories have voluntarilyupgraded to ISO 15189 program

• On-site surveillance visit at mid-cycle


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



• Internationally recognized as competent to evaluate diagnostic services. Accredited to ISO 17011 Conformity assessment – Requirements for accreditation bodies accrediting conformity assessment bodies


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


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

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


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


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



Values

• Responsible

• Objective

• Consistent

• Transparent

• Open-minded

• Respectful


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


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


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.



Assurance of Technical Competence

Accreditation will elevate the confidence of patients, users of the services, administration, government and staff



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



Staff confidence and professional development

Meeting the accreditation requirements will open up interest and engagement in quality management.



Demonstrates a commitment to quality and accountability



Cultivation of Fresh Ideas

Assessors involved in the IQMH program see many different facilities and solutions to common problems.



Loss of Isolation

Laboratory managers will frequently work with other facilities to meet the more difficult requirements.

• Mandatory versus Voluntary program

• Consistency between assessment teams

• Sustainability and maintenance of a quality management system


Not Just About Meeting the Standards

• It is about:

• Self-correcting

• Internal responsibility and internal reporting


Benefits to the Patient

Assurance of quality, standardization, consistency in care

Happy and satisfied staff

Confidence in the health care system


THANK YOU!

[email protected]


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