New CSA Group Standard on Requirements for the Design, Development and Validation of Laboratory-Developed Tests by Isolde Seiden-Long, Clinical Biochemist with Calgary Laboratory Services, Foothills Medical Center and Peter Lougheed Center hospitals; Clinical Associate Professor, Department of Pathology and Laboratory Medicine, University of Calgary
IQMH Holds Successful Spring Forum
By: Julie Coffey, Director of Education, IQMH Centre for Education
IQMH hosted its second largest event of the year on April 27, 2018: Quality System Excellence—Barriers and Solutions from Your Peers. It was the first event of its kind where laboratory and diagnostic imaging professionals were brought together to learn from each other. The event format was unique with the laboratory and diagnostic imaging streams meeting separately but simultaneously uniting for the plenary sessions on topics relevant for both groups.
Julie Coffey began the day by inviting the audience to consider exactly why implementing a quality system is a good idea, and to embrace the idea that accreditation is a checkpoint, not an endpoint. The subsequent presentations further explored selected elements of a quality system, the barrier encountered and solutions to those barriers. We proudly present a summary of the presentations along with selected slides from each.
Lab and DI Collaboration on Quality – Evolving Together to Improve by Joan Carlson, Provincial Quality Lead in Laboratory Services for Alberta Health Services
Joan started her talk with an exploration of ways laboratory and diagnostic imaging could collaborate to develop a quality management system. She discussed shared advantages that laboratory and diagnostic imaging enjoy, and the common challenges. In particular, there is a great opportunity for collaboration in facilities where the parent organization quality direction is lacking or non-specific. Great opportunities for collaboration include:
- Patient surveys
- Patient registration processes
- Integration of reports
- Internal audits
- Interventional radiology and pathology
- Quality management system policies
- Shared personnel that perform both lab and DI functions
- Non-invasive molecular imaging
What was, What is and What it Could Be – Keeping Your Management Review Effective by Sarah James, Quality Manager, Timmins Cluster Laboratory Partnership
Sarah provided an engaging talk focused on Management Review pulling from her own experience as the quality manager for the Timmins Cluster Laboratory Partnership. She covered who does management reviews, when, the challenges of data collection, barriers to getting good reports, and strategies for running an effective meeting.
Risk Management Implementation Strategy at PHO Laboratory by Georgina Ralevski, Manager, Quality Assurance and Customer Service, Public Health Ontario
Georgina outlined the steps and strategies that Public Health Ontario Laboratory took to implement and integrate risk management with their quality system in the time frame of only four months. This included getting support from senior leadership, developing a risk management framework, communication and education, and managing risk at strategic and business levels.
Overview of Laboratory Overutilization by Christopher Naugler, Professor in the Departments of Pathology, Family Medicine and Community Health Sciences, Cuming School of Medicine, University of Calgary
Christopher began the laboratory-specific stream of presentations with a fascinating discussion on the overuse of laboratory testing. He began with the statistic that although laboratory tests drive 70% of downstream decisions, up to 35% of laboratory tests are misutilized. He explained exactly how we can detect overutilization of a test, which tests to target, and some tools to manage the test utilization.
Point-of-Care Testing – Overview of an Evolving Approach to Direct Patient Care by Evan Ntrivalas, Director of Medical & Scientific Affairs, North America, Nova Biomedical
In this presentation sponsored by Nova Biomedical, Evan discussed an overview of the changing market dynamics for point-of-care testing and chronic disease management. He discussed the interferences that can affect point-of-care glucose meters and the consequences. He then related those to changing American guidelines for manufacturers of glucose meters and the impact of those changes on hospitals.Clinical Laboratory Testing and Interpretation—The Critical Need for Harmonization by Khosrow Adeli, Head & Professor of Clinical Biochemistry at the Hospital for Sick Children and the Department of Laboratory Medicine & Pathobiology, University of Toronto
Khosrow passionately presented the unfortunate consequences of variable and poorly harmonized laboratory tests. Many different laboratory measurement procedures that claim to measure the same measurand give different results for the same specimen. He presented the roadmap for harmonization of laboratory procedures:
- Prioritize measurands by medical importance
- Coordinate the work of different organizations
- Develop technical processes to achieve harmonization when there is no reference measurement procedure or no reference material
- Promote the surveillance of the success of harmonization
Khosrow walked us through important Canadian initiatives for laboratory test harmonization currently underway through the CSCC Working Group on Reference Interval Harmonization and the CALIPER initiative.
The Medical Laboratory and Transgender Healthcare by Miranda Wozniak, Hematology Discipline Head, LifeLabs
Miranda used a powerful case study to illustrate the main healthcare obstacles of the transgender population as it relates to pathology and laboratory medicine. She began by emphasizing that the transgender population is one of the most marginalized and under-served in our society, and it is a large population, whose true numbers are unknown. In addition, societal intolerance and discrimination deter this population from seeking adequate medical care.
Obstacle #1: Many medical and laboratory professionals are unfamiliar with the terminology, epidemiology, and medical needs related to the transgender population.
Obstacle #2: Laboratory Information Systems often lack the capability to document affirmed gender and other important information.
Obstacle #3: Lack of transgender-specific reference intervals.
Obstacle #4: Many laboratory professionals have limited experience handling and interpreting surgical and cytological specimens from transgender individuals.
Obstacle #5: Ministry of Health Ontario billing which requires designation of sex/gender for the purposes of billing, otherwise it is rejected
Isolde presented the details of a new standard for lab-developed tests, specifically the quality management system, pre-validation, validation and post validation requirements.
- Test requirements
- Validation master plan
- Analytical instrument qualification
- Risk assessment
- Preliminary experiments
- Establish performance characteristics
- Excluded characteristics
- Measurement uncertainty
- Software verification
Integrated Quality Management System: Lessons Learned from High Risk Industries by Zoran Bojic, Quality Management Leader, Vascular Access/Diagnostic Imaging, Diagnostic Imaging, The Hospital for Sick Children
- Transfer to routine use
- Test interpretation
- Retention of validation records
Zoran opened the diagnostic imaging stream with an inspiring look at lessons learned from other high-risk industries such as aviation, nuclear power, and petrochemical. He walked us through the benefits of an integrated quality system, and the necessary human elements:
- Embracing change
- Staff engagement
- Just culture
- Human factors engineering
- Intuitive thinking vs. analytical thinking
- Decision-making fatigue
The Value of Training “You Don’t Get a Second Chance to Make a Good First Impression” by Anne Robertson, Director of Medical Imaging, Grey Bruce Health Services
Anne presented an engaging and warm summary of how to create an effective training program, beginning with the simple but often overlooked step of reviewing the job description of the position and the values of the organization with the trainee. She clarified exactly what the benefits of an effective training program are for both the facility and the trainee and spent some time exploring the inevitable barriers created by generational differences and how to overcome them.
Competency Assessment: A Diagnostic View of Your Training Program by Colette Swift, Manager, Laboratory Medicine at Peterborough Regional Health Centre
In this interactive presentation, Colette provided an overview of strategies for a useful competency assessment program. She created a strong link between training and competency assessment by emphasizing that one of the primary reasons to conduct competency assessment is to determine if training has been effective. Challenges include staff perception, time and record keeping, all of which were addressed in this session.
Diagnostic Imaging Quality Indicators by Jeff Kerk, Shared Director of Diagnostic Services, Georgian Bay General Hospital and Orillia Soldiers' Memorial Hospital
This presentation took the diagnostic imaging group through the basic elements of a good quality indicator program. Jeff incorporated many examples based on his own experience managing diagnostic imaging services in Ontario. These examples allowed the group to see exactly how quality indicators should link back to hospital strategy and drive quality care.
Identifying and Executing Patient-centric Quality Assurance Strategies by Jeff Frimeth, President and Chief Medical Physicist, JF Medical Physics Inc.
For the final diagnostic imaging presentation, Medical Physicist Jeff Frimeth eloquently discussed quality assurance strategies with the goal of ensuring all patients receive the same quality of care in regards to image quality and radiation dose. Current compliance requirements in Ontario (i.e. RED and HARP Acts) do not significantly address these two parameters. As a result, the potential for sub-optimal quality of care exists for all patients, unless additional appropriate strategies are implemented. Jeff illustrated that this alone identifies the basic difference between compliance and going above and beyond compliance and how to achieve essential patient-centric quality assurance processes.
Closing Remarks by Julie Coffey, Director of Education, IQMH
Julie Coffey closed the forum with a second invitation to carefully consider and articulate the “Why” behind every quality system element in order to drive staff enthusiasm and engagement in these important processes and to move beyond mere compliance. Ten examples linking back to the day’s presentation were provided with some suggestions for the “why” behind each. We were encouraged to think of and communicate those “why” statements frequently, and even to consider adding descriptive adjectives to our quality systems elements.
IQMH offers gratitude to the fourteen speakers who took the time to prepare and present at this unique event, and to our six sponsors:
Exhibit Floor Sponsors
- Affinity Biologicals
- Nova Century Scientific
- Omnitech Health
Download the Agenda.