This document discusses key aspects of organization and leadership in laboratory environments. It emphasizes the importance of establishing a clear mission, vision, and values. An effective organizational structure should define lines of authority, communication, roles, and how responsibilities are delegated. Quality planning is also crucial to ensure the laboratory remains proactive and reactive to quality issues. The scope of services, qualifications and responsibilities of the laboratory director, and effective communication are also identified as essential components of organization and leadership.

1. ‫بكم‬ ‫وسهال‬ ‫اهال‬

2. QSE :The 12 Quality System Essentials in Laboratory
Environments
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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

11. Communication
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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

14. Communication
• R5 in Communication
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15. questions ?
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