Building, Educating, coaching, supporting

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As an experienced medical Laboratory Technologist with nearly 40 years front line and management experience, I firmly believe that there is a real need for the laboratory to improve Quality Management Systems and to be able to increase efficiencies and effectiveness within their businesses quality processes and programs in order to grow and thrive. The way to do that is through an effective Quality Management System (QMS).  

A QMS is a roadmap, or a business plan, towards better quality. Fundamentally it is how an organization or business should operate, it is the basic foundation for being successful.

A QMS for laboratories plans, controls, and improves the elements that impact results and consistently meets customer requirements, enhancing their satisfaction. It is expressed as the organizational goals and aspirations, policies, processes, documented information, and resources needed to implement and maintain it.

Within the laboratory environment, the QMS is made up of twelve quality system essentials (QSEs). These are: organization, customer focus, facilities and safety, personnel, purchasing and inventory, equipment, process management, documents and records, information management, nonconforming event management, assessments, and process/continual improvement. Different accrediting bodies (e.g. ISO 13845) may have QSEs differing in number or in name but will still cover the fundamental aspects of quality.

Think of it like the structure of a house, where the QMS is the roof which is supported by twelve supporting beams. If one (or more) of the beams is weak or broken, the entire structure is at risk of having problems.

Where I can assist in the development of, improvement of or implementation of a QMS:

• Consult, coach and educate staff on Quality Management Systems to enable leaders to ensure the right quality processes, standards, practices, are being adopted and followed
• Create, maintain, and deliver Quality Management/Systems training programs and activities which promote awareness and compliance within the organization
• Provide support, training, and education throughout the organization for quality and safety related education including leading presentations.
• Provide medical laboratory technical and quality consultation to the management, leadership, or executive team
•  Provide ongoing leadership and support in standardization and streamlining of processes, in accordance with applicable provincial and national regulations and legislation including Clinical Laboratory Standards Institute (CLSI) Standards, Laboratory Licensing and relevant Accreditation standards.
• Interpret and implement quality management, regulatory requirements, document management, incident reporting, continuous improvement, and lean concepts.
• Act as content expert and consultant regarding current and proposed quality systems legislation, regulation and best practice and the corresponding impact to the organization
• Act as content expert and consultant regarding current and proposed quality systems legislation, regulation and best practice and the corresponding impact to the organization
• Oversee the development and maintenance of quality documentation. Ensure policies, processes, procedures, and forms remain current with applicable regulations, legislation and established best practices 
• Oversee document management system and records management
• Provide guidance related to troubleshooting, technical and quality assurance/quality systems support for methodologies, equipment and supplies currently in use
• Provide guidance and reviews for the evaluation and validation protocols for new technologies, equipment, software, supplies and procedures
• Develop and implement quality and performance metrics. Report, monitor and assess trends on quality indicators.
• Oversee and support regulatory compliance in competency assessment programs
• Provide guidance and review the proficiency testing evaluations, exception letters, and result summary sheets.
• Support development and implementation of internal surveys and audits to support continuous improvement and change management. Conduct internal audits as required
• Lead the receipt, documentation, investigation, and resolution of customer complaints t to ensure regulatory compliance and customer satisfaction
• Initiate and support nonconformance management processes including corrective action planning and implementation, review for completeness and closure and provide organizational support
• Lead, provide guidance or participate in collaborative root cause analysis investigations, recommend improvements, compile reports and process flow charts.
• Evaluate the effectiveness of systemic non conformances and corrective action plans, identify trends
• Oversee facility compliance with occupational health & safety initiatives
• Ensuring staff training is in place and up to date
• Coordination and preparation of Quality projects, implementation, and guidance
• Facilitate and support the accreditation processes throughout the organization Mentor and lead employees on organizational quality management systems.
• Oversee that operations is in compliance with provincial legislation, regulation and guidelines and provide guidance when needed
• Liaise with regulatory agencies on required standards and guidelines, other external organizations, government, professional, regulatory, and educational bodies and stakeholders Represent QA as an ambassador for regulatory compliance
• Participate in the preparation of on-site external audits by accrediting bodies (e.g. CAP, CPSA, Health Canada, etc.) 
• Participate on project teams as a quality representative
• Facilitate stakeholder group meetings
• Prepare and present reports to Leadership, management or executive as required

Skills I bring to you:

• Strong Technical and Quality Systems knowledge
• Proven competence in facilitating the processes used to design, develop, validate, implement, monitor, control and continuously improve a Quality Management System within a regulated environment
• Proven ability to facilitate the processes used to design, develop, validate, implement, monitor, control and continuously improve, a Quality Management System within a regulated environment.
• Able to bring innovative solutions to improve processes in Quality Assurance
• Excellent customer service, interpersonal and relationship building skills
• Strong communication skills (verbal, written and listening)
• Strong disposition towards collaboration and effective team participation 
• Ability to work with people in team environments, often serving as team leader without having direct managerial control
• Demonstrated problem solving skills and attention to detail
• Good critical thinking, decision making, problem solving and prioritization skills
• Strong organizational and time management skills
• Project management skills
• Ability to work effectively with minimal supervision
• Competent technological writer (SOPs, Investigation Summary, SBAR)
• Knowledge of health and safety best practices, standards and compliance
• Responding to safety issues or incidents to initiate changes or improvements to avoid further incidents
•  Strong communication and interpersonal skills
• Demonstrated ability to understand and execute verbal and written instructions
• Facilitation skills necessary to lead specific teams
• Strong organizational, change and incident and project management skills to ensure that deliverables are achieved on schedule in a controlled manner
• The ability to use sound risk management analysis to assess the regulatory and business impact of prioritizing goals
• Excellent verbal communication skills to effectively communicate decisions and seek input
• Excellent technical writing skills to create and maintain documentation
• Working with teams to develop systems, frameworks, and SOPs in support of business quality, efficiency, consistency, and safety
• Ability to facilitate and lead change within the business and externally with key stakeholders
• Preparation regular management reports, business cases and proposals
• Intermediate to advanced computer skills such as but not limited to Microsoft Office (Word, Excel, PowerPoint, Visio, Outlook), Incident Management System software, familiarity with different LIS, Document and Accreditation Management Systems

My Background includes:

• Nearly 40 years experience in large medical laboratory systems (locally, provincially, and national), with a subspecialty in areas of Histopathology/Pathology, Preexamination processes, Safety and Quality
• Accreditation assessor experience
• Knowledge and expertise in Quality Management Systems and Quality System Essentials
• Working knowledge of CPSA, CAP, ISO 15189, DAP, Health Canada and CLSI standards and other legislation and guidelines.
• Working knowledge of safety hazards inherent in the work performed and the appropriate safety policies, practices, and preventative measures.
• Working knowledge of Transportation of Dangerous Goods (TDG), Safety regulations and WHMIS.
• Working knowledge and understanding of a proficiency testing programs
• Working knowledge of Health Information Act and other privacy legislations
• Registered Medical Laboratory Technologist (MLT) with the Canadian Society for Medical Laboratory Science (CSMLS) and the College of Medical Laboratory Technologists of Alberta (CMLTA)