2. QSE :The 12 Quality System Essentials in Laboratory
Environments
2
3. 1- Organization and leadership
By Mohammed Ahttani
Jeddah regional Laboratory Chief
Technologists
4. Learning Objectives
• Why we need mission, vision amd values?
• Understanding the organization structure
• Importance of planning ( quality, staffing, financial ..etc)
• Component of scope of service
• Qualifications and responpilties of lab director
• Importance of communication
5. Mission, vision and values
• I not sothing just for show,its what we are.
• Mission: A statement of why the organization exists
• Vision: A clear, specific, compelling picture of what the organization will look like at a specific time
in the future (one, two, or five years)
• Value: he boundaries within which the organization will operate in pursuit of its vision
• Formulating a Vision for Quality:
o Future-oriented -a picture of what is possible for the laboratory’s quality in five to 10 years
o Clear-should be easily visualized, described, and understandable by laboratory staff
o Aligned -with the laboratory’s and/or organization’s mission and values
o Aspirational-representing an achievement that is a challenge, but worthwhile
o Inspirational - provides the laboratory with a vividly positive image of its quality “destination” that engages staff,
thereby stimulating excitement and enthusiasm
o Meaningful-is relevant and gives staff a larger sense of purpose
o Consistent-is a sustainable and unchanging declaration of where the laboratory is headed
6. Organization Structure
• Leadership is responsible for creating and maintaining a laboratory organizational structure that
ensures quality by creating a framework to organize the employees
• Leadership is also responsible for maintaining an organizational structure that achieves the
optimal degree of congruence with several related aspects of the laboratory, such as its:
o Quality policy, goals and objectives.
o Scope of services
o Personnel management
• Leadership is responsible for understanding and adhering to all requirements related to
establishing and maintaining its laboratory’s legal identity (requirements of its parent organization).
• The laboratory’s organizational structure should accurately reflect the following:
o Lines of authority
o Lines of communication
o Roles or functions
o How responsibilities are delegated, controlled, and coordinated
7. Organization Structure
• Committees
• Common laboratory roles represented in Organization Structure :
o Laboratory director
o Deputy director
o Clinical consultant
o Head of units
o Units supervisors
o Quality
o Safety
o Training
o Infection control
o Public health
o Testing personnel
o Support staff
8. plans
• Qulaity plan: Quality planning is important because it reinforces the commitment to quality,
focuses the staff on defined priorities, and helps align resources.
• Be proactive ant reactive
• Quality Planning Cycle: all plans should be reviewed for effeteness.
9. scope of service
• Laboratory services are available to meet patient needs and are in accordance with applicable
national standard (CBAHI)
• The description of the scope of services should be easily accessible to all laboratory staff, as well
as internal and external customers.
• Components:
o list of the laboratory disciplines (e.g. hematology, cytogenetics, point-of-care testing, anatomic pathology, transfusion
services)
o Demographics
o Available tests their associated TATs, units of reporting, type of tubes, priorities, special consideration, patient
preparation etc..
o Listing of critical values, modes of notification, and TAT for notification
o TAT for notification of sample rejection and requests for recollection
10. Qualifications and responpilties of lab director
• Qualifications depend on :
o Tests complexity
o National regualtions and after the accriditations bodies
• Responpilties:
o compliance with all relevant laws and regulations.
o ensures the implementation of the policies
o participates actively in supporting the safety of patients
o ensures the efficient utilization of all resources.
o Participate actively in committees
o Plans and Improvement and follow up
12. Communication
• provide coordination, guidance and instruction for the various processes and activities directed at
effectively communicating quality- related information.
• What to communicate:
o Quality-related information to be communicated includes, but is not limited to:
o Laboratory’s and/or organization’s mission, vision, and values
o The laboratory’s quality policy, which should include:
- Quality and good professional practice
- Compliance with applicable laws, regulations, and accreditation, and organizational requirements
o Laboratory’s and/or organization’s strategic plans
o Laboratory’s and/or organization’s quality goals and objectives
o Conclusions of management review, including assessment of the effectiveness of the QMS and summary of key
performance indicators
o Continuous improvement initiatives and their outcomes
o Summaries of internal audits
o Summaries of external assessments
o Changes to QMS policy statements, processes, and procedure
o Issues and problems that may affect the continuity of service and/or quality across work shifts (i.e.,
o “hand-off communication)
o The mechanism or process by which laboratory staff communicates concerns or complaints about the
laboratory's safety, quality, privacy/confidentiality of patient information, and business practices
13. Communication
• How
o Mechanisms used to communicate quality-related information include:
Management, staff, and committee meetings, and associated meeting minutes
o One-on-one meetings
o Newsletters
o Electronic communication (e.g., e-mail, intranet)
o Special or urgent announcements and/or notices
o Posting of data and information (e.g., quality policy, quality metrics, results of customer satisfaction
surveys) in prominent locations in the laboratory
o Asking staff to read and sign documents to acknowledge receiving and understanding them (e.g., new
or revised procedures)
o Presentations by leadership or staff I
Periodic reports or updates to higher admins or owners
