QSE Consulting

QSE Consulting can provide a full range of management consulting services tailored to your specific needs. The company has built a reputation for assisting clients in the ongoing quest for increased cost effectiveness of operations, while maintaining quality expectations.

Organizations having a desire to achieve sustainable success benefit from our broad base of experience. QSE Consulting’s team of professional consultants brings comprehensive experience in all aspects of management, as well as regulation, professional standards and accreditation.

Headquarters, Address, and Contact Information:

QSE Consulting Inc

Corporate Office
Sheila Woodcock
Phone: 902-766-4295
Mobile: 902-521-6507
Fax: 902-764-2135
Email: swoodcock@qseconsulting.com
Website: www.QSEconsulting.com
Linkedin: http://ca.linkedin.com/pub/sheila-woodcock/16/342/843

Toronto Office
Mary Anne Cecutti
Phone: 416-488-0834
Mobile: 416-488-0834
Fax: 416-489-8062
Email: macecutti@qseconsulting.com
Website: www.QSEconsulting.com
Linkedin: http://ca.linkedin.com/pub/mary-anne-cecutti/a/17/188

Brief Corporate History

QSE Consulting Inc is a Canadian company that provides healthcare management consulting services with a particular focus on quality, standards and education. Founded in 2000 the company has expanded and grown each year. With offices in Eastern and Central Canada we are positioned to serve clients across the continent. We have established a reputation for the delivery of quality, cost-effective services. Our team of professionals work together to contribute to the achievement of quality goals in health related services across the globe. We specialize in helping health care facilities, medical laboratories in particular, in their quest for compliance with quality standards and regulations.

Short Bio on Principal Officers and Consultants

Sheila Woodcock is a senior executive with more than 30 years experience in health care, education, professional regulation and consulting.   She has worked in both the public and private sectors, with leading health care organizations at provincial, national and international levels. Prior to establishing QSE Consulting, Sheila was the first CEO of the College of Medical Laboratory Technologists of Ontario, establishing the infrastructure and processes for the regulation of 8,000 technologists. She is the founder of the successful Executive Edge conference series, in partnership with Robert Michel of The Dark Report. Held in Toronto and delivering information of innovations in laboratory management for laboratory leaders, speakers and delegates come from across Canada and around the world.

Recognized as a leader in her field and an authority on quality management systems, Sheila is the elected Chair of the Canadian Standards Association (CSA) Technical Committee for Medical Laboratory Quality Systems and a Standards Council of Canada delegate at the ISOTC212/WG1 meetings; contributing to the development of ISO15189, an international quality standard for medical laboratories. She also chaired the Clinical & Laboratory Standards Institute (CLSI) Area Committee on Quality Systems and Laboratory Practices 2002-2008. She is a contributing author to many of the CLSI quality documents and a frequent speaker at professional meetings and conferences. She has numerous publications and has done presentations on lab redesign, restructuring, defining roles and responsibilities, benchmarking and quality systems. Since establishing QSE Consulting Sheila has led successful operational reviews, analysis and evaluation projects, feasibility studies, strategic planning sessions and quality systems implementation projects. Sheila has also undertaken projects in Tanzania and Mali, as a volunteer and on contract.

She has been recognized with awards from CLSI, the Canadian Society of Laboratory Science and the Ontario Society of Medical Technologists.

Mary Anne Cecutti has worked with QSE Consulting Inc since 2001 and prior to that successfully operated as a consultant for more than 10 years.  She has more than 20 years experience in laboratory and regulated health care environments and has worked on multiple facets of a nationwide FDA/Health Canada regulatory compliance project. She has worked in community and teaching hospitals, with the Ministry of Health, Laboratory Services Branch as a Laboratory Inspector and successfully managed projects for CBS, CMLTO and Ministry of Health and Long Term Care in Ontario.

She has consulted in highly regulated environments; assessed and provided solutions to operational issues associated with regionalized testing; assessed and revised business process flow and laboratory process flow; assessed existing and developed new functional processes; designed and planned laboratory facilities; participated in strategic planning for various organizations; and facilitated work teams in the redesign of workflow and implementation of the new design which resulted in more efficient operations with fewer staff better able to cope with workload.

Recent projects have included working with a number of clients to help them meet and implement provincial, national and international accreditation standards based on ISO 15189 and ISO 17025. These clients have included Health Canada, clinical laboratories, water treatment/testing laboratories and a start up Biotech Company.

In 2005 Mary Anne co-founded Executive Edge – Innovations in Laboratory Medicine for Lab Leaders together with Sheila Woodcock of QSE Consulting Inc and Robert Michel of the Dark Report.  This two day conference, which she co-produces, is held in Toronto each year and brings the best and the brightest minds in the industry from Canada and around the world to the Canadian laboratory community.

Skills and Areas of Expertise

QSE Consulting delivers a full range of quality management systems consulting services, customized to the specific needs of your facility. We have experience with ISO15189, ISO17025 and a wide range of accreditation standards, as well as Lean type of assessments.

Quality

Gap analysis audit

• A readiness check and compliance assessment consists of an on-site review of your laboratory with an unbiased audit for accreditation or ISO certification purposes. A detailed report will outline your laboratory’s current status, action needed and estimated resources required to achieve compliance.

Document development

• We will facilitate the development of supporting documents for your Quality Management System (QMS): Policies, Processes and Procedures, as well as a Quality Manual

QMS maintenance

• Management review, process improvement, setting quality objectives and post accreditation corrective action.

Standards

QSE Consulting brings comprehensive experience in regulation and professional standards.

Today’s facilities have to meet defined quality standards required by provincial and federal governments. With knowledge of existing regulations we can advise on expected standards of operation. We can audit your operations and give an opinion on your readiness for compliance with standards or assist in the development and application of relevant policies, processes and procedures.

Education

The learning organization is one that believes in supporting staff in the quest for lifelong learning and professional development. QSE Consulting can help your organization develop the potential of individuals and teams.

QSE Consulting partners with the Dark Report to produce Executive Edge a bi-annual conference for senior laboratory professionals. Inspired by the success of the Executive War College in the US and Frontiers in Frontiers in Laboratory Medicine (FiLM) in the UK, this annual event brings together lab leaders from across Canada to network with the brightest and best in laboratory medicine both national and international. It has become the premier source for up-to-date information on market trends, the latest innovations in clinical laboratory management, application of new technologies and effective financial strategies.

Process Improvement

We can support clients in the ongoing quest for increased cost effectiveness of operations, while maintaining quality expectations:

• Workflow analysis including Lean methods and tools
• Process redesign for improved productivity and efficiency
• Process flowcharting and procedure development
• Managing the implementation of change
• Bench marking against best practices

Management Consulting

QSE Consulting provides a full range of management consulting services tailored to meet your specific needs.

• Project coordination
• Strategic planning
• Feasibility studies
• Policy and procedure development
• Planning and facilitation for conferences, seminars or meetings

List of Clients and Work Assignments in the Last 3 years

Government

Health Canada, 2008

Developed an evaluation tool for the assessment of laboratory services provided to Canadians, and their dependants, stationed with Canadian Missions overseas as part of the “Public Service Health Overseas Program” project.

New Brunswick Department of Health, 2007

Conducted a comprehensive review and assessment of the current state of public health laboratory support in New Brunswick in the absence of a Provincial Public Health Laboratory. This included an in depth survey of services provided, on site visits to regional laboratories and in depth research of the provision of public health laboratory services nationally.  Recommendations and changes required to meet Federal expectations and best practice standards, together with a business case to address gaps in services and quality, were developed and presented.

Ontario Ministry of Health and Long Term Care, Laboratories Branch, 2006/07

Retained to conduct a third party review of the Eastern Ontario Laboratory Association’s (EORLA) business case to determine the validity of the EORLA service delivery model projections regarding: cost avoidance and efficiencies in hospital laboratory expenditures; with the expectation of greater efficiency in the use of human, financial, medical, scientific and technological resources producing a robust and viable integrated laboratory. A detailed analysis of all aspects of the business case was conducted by a team of eight consultants.

Agencies and Municipalities

The Royal College of Physicians and Surgeons of Canada, 2009

Designed, implemented and analyzed a detailed on-line survey as part of the data gathering for a study of quality practices in pathology and laboratory medicine. Also surveyed related organizations and conducted literature reviews, to formulate a detailed report to include recommendations for strategies and solutions.

Cancer Care Ontario, 2006

Facilitated the implementation of the Pathology Checklist Reporting Project, based on the College of American Pathologists (CAP) Pathology checklists for cancer surgery. This entailed preparation of technical documents detailing audit criteria, auditing process, coding rules and glossary of equivalent terms; interviews with Regional Vice-Presidents; as well as organizing and supporting a three week tour of Ontario in 23 locations, to present the results of the first audit of 44 hospitals.

Hospitals

Southlake Regional Hospital, ON, 2008

Undertook a study of pathologist staffing required to support the transition from a small community hospital to a large regional centre, benchmarking against other similar facilities and studies done nationally as well as in other countries.

Grand River Hospital, Kitchener, ON, 2008

Developed a corrective action plan for implementation over an 18 month period, based on deficiencies cited in a recent accreditation site visit and taking into account pans for merging laboratory operations in two facilities.

York Central Hospital, Richmond Hill, ON, 2004, 2008

Facilitated and supported the implementation of a quality management system for the laboratories, including production of a quality manual, process mapping and development of policies and procedures and staff education over an eight month period. Requested to return 4 years later to review progress and readiness for second accreditation in 2009.

Prince Rupert Regional Hospital, BC, 2008

Conducted a review and analysis of current workflow patterns and laboratory layout; developed recommendations and options for the layout and design of a new laboratory, including the out patient blood collection area. The final report included supporting documentation such as process maps, movement diagrams and drawings for a number of potential layouts of the new laboratory space.

Hospital for Sick Children, Toronto ON, 2004 to 2008

Conducted an operational review of one laboratory division, recommended changes to policies, processes and procedures, organizational structure and facility design. Retained on a second contract to facilitate the implementation of the changes recommended and ensure that all of the required procedures were documented.   Subsequently engaged for analysis and revision of staff roles and responsibilities and associated position descriptions.  Produced a “Guide to Child-friendly Blood Collection Procedures” that will be distributed to hospitals and laboratories throughout Ontario.

Private Industry

LifeLabs Vancouver & Victoria BC, 2009

Developed and applied appropriate checklists to assess the readiness of the two large reference laboratories for ISO15189 accreditation. The assessment was conducted in two parts and included visits to a representative number of Patient Service Centres. Reports were provided indicating the extent of compliance and recommendations for changes to achieve compliance.

Gamma Dynacare Medical Laboratories, Brampton, ON, 2009

Conducted a third party audit of a testing process set up in a small community setting to provide timely INR results for local physicians, to determine the compliance with Ontario Regulations and provide an assurance of patient safety.

Trainor Laboratory, Winnipeg, MB 2009

Supported the laboratory with the implementation of the basic requirements of a quality management system and preparation for provincial accreditation. This included an initial gap analysis, review & revision of manuals, development of new manuals where required, review of associated procedures, design of a document control system and staff education.

International Projects

Clinical and Laboratory Standards Institute (CLSI) in partnership with CDC and Ministry of Health and Social Welfare, Tanzania

Three year project, funded by PEPFAR, to educate and support the five zonal hospital laboratories in preparation for accreditation to ISO15189. Site visits once a year and workshops between visits have resulted in significant progress. This has been supplemented by in-country mentors for 12 weeks in 2008 and 2009. Accreditation of the first laboratory is expected in 2010.

Clinical and Laboratory Standards Institute (CLSI) in partnership with NIAID/NIH, 2007/08

Provided required diagnostic laboratory support to ensure that a sustainable quality management system was in place for a clinical trial for a malaria vaccine taking place in Mali, NW Africa. ISO15189 was chosen as the reference standard and working with the staff over a period of six months, quality practices were implemented and monitored.

Testimonials

“QSE Consulting is a small company with a BIG reputation; they are known across Canada for getting the job done”
Dr. Michael Noble, Program Office for Laboratory Quality Management, University of British Columbia.

“We would highly recommend QSE Consulting after our very positive experience working with them. They are knowledgeable, efficient and provided us with a comprehensive report”
Lori Clarke, Laboratory Services Consultant, Department of Health and Welfare, New Brunswick.

“We depended on Sheila and her QSE team to help us prepare for our accreditation and they didn’t let us down”
Clare Johnson, Director, Diagnostic Services, York Central Hospital, Ontario.

“The accreditation team is very impressed with the manuals prepared by QSE Consulting”
Trainor Laboratory, Winnipeg, Manitoba