1. Laboratory Personnel
Dr/Ehsan Moahmen Rizk

2. Purchasing & Inventory Information Management Occurrence Management
The Quality Management System
Organization
Personnel
Equipment
Purchasing & Inventory
Information Management
Process Control
Documents & Records
Occurrence Management
Assessment
Customer Service
Process Improvement
Facilities & Safety
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3. Laboratory Staff YOU ARE: The most critical part of the quality system
The laboratory’s greatest asset
An important partner in patient care
YOU ALSO:
Bring your integrity and professionalism to the healthcare community
Success or failure of quality system is dependent on
the laboratory staff
Knowledge and skills
Motivation
Commitment
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4. Competency Assessment
Job Qualifications
Personnel Management
Continuing Education
Job Descriptions
Orientation
Training
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5. Motivated employees are more committed to their work
praise
recognition
bonuses
benefits
flexible time …
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6. Job Descriptions
“Laboratory Management shall have job descriptions that define qualifications and duties for all personnel.”
ISO 15189:2007
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7. Qualified New Employee Orientation
Job Description
Orientation
Task-specific Training
Retraining
Competency Assessment
Competency Recognition
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8. Orientation
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9. Task-specific Training Competency Assessment Competency Recognition
Job Description
Task-specific Training
Retraining
Competency Assessment
Competency Recognition
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10. Laboratory director
provide advice to those requesting information about the choice of tests, the use of the laboratory service and the interpretation of laboratory data
relate and function effectively with:
applicable accrediting and regulatory agencies,
Clinical Staff
the healthcare community
the patient population served
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11. Laboratory director (continue)
Define, implement and monitor standards of performance and quality improvement of the medical laboratory service
Ensure that there are sufficient qualified personnel with adequate documented training and experience to meet the needs of the laboratory;
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12. Laboratory director (continue)
Plan, set goals, develop and allocate resources appropriate to the medical environment; including budget planning and financial management, provide educational programs for the medical and laboratory staff and participate in educational programs of the institution;
implement a safe laboratory environment in compliance with good practice and applicable regulations
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13. Responsible for the day-to-day management of the testing laboratory
Laboratory Manger
Responsible for the day-to-day management of the testing laboratory
Ensuring that there are enough personnel with adequate training and experience to conduct the work
Ensuring that the laboratory has a manual of standard operating procedures that are complete, up-to-date, available for personnel performing tests, and followed by those personnel
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14. Laboratory Manger (continue)
Maintaining a quality assurance program to assure the proper performance and reporting of all test results; maintaining acceptable analytical performance for all controls and standards; maintaining quality control testing; and assuring and documenting the validity, reliability, accuracy, precision, and performance characteristics of each test and test system
Taking all corrective actions that may be necessary to maintain satisfactory operation and performance of the laboratory
Responsible for review, interpretation, and reporting of test results
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15. QA manger
Design, implementation, maintenance and improvement of the quality management system. This include the following:
Management support of all laboratory personnel by providing them with the appropriate authority and resources to carry out their duties;
Arrangements to ensure that management and personnel are free from any undue internal and external commercial, financial or other pressures and influences that may adversely affect the quality of their work
Policies and procedures for ensuring the protection of confidential information
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16. QA manger (continue)
The organizational and management structure of the laboratory and its relationship to any other organization with which it may be associated
Specified responsibilities, authority, and interrelationships of all personnel
Adequate training of all staff and supervision appropriate to their experience and level of responsibility by competent persons
Technical management which has overall responsibility for the technical operations and the provision of resources needed to ensure the required quality of laboratory procedures
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17. Lab. technician
Performing laboratory tests in order to produce reliable and precise data by carrying out routine tasks accurately and following strict methodologies to carry out analyses
Preparing specimens and samples
Constructing, maintaining and operating standard laboratory equipment
Ensuring the laboratory is well-stocked and resourced
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18. Lab. Technician (continue)
Recording the results and conducting them to lab manger
using computers and performing mathematical calculations for test results
keeping up to date with technical developments, especially those which can save time and improve reliability;
Helping lab manger in conducting searches
following and ensuring strict safety procedures and safety checks
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19. Computer Lab. technician
Responsible for the maintenance and operations of computer labs and related equipments as printers&Faxes.
Assist lab users with computer-related issues such as creating user log-on accounts and passwords,
The operation of the computer and the network
Keeping records of equipment and lab supplies
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20. Internal audits
In order to verify that operations continue to comply with the requirements of the quality management system, internal audits of all elements of the system, both managerial and technical, should be conducted at intervals defined by the system itself.
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21. Internal audits (continue)
Audits should be formally planned, organized and carried out by the quality manager or designated qualified personnel. The procedures for internal audits should be defined and documented and include the types of audit, frequencies, methodologies and required documentation.
The results of internal audits should be submitted to laboratory management for review.
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22. Competency Assessment Methods
Technologist Name
Technologist Title
Procedure for Evaluation
Evaluation Date
Evaluator
Procedure item
Accept
Partial No
Comment
Read procedure manual
Equipment set up appropriately
Work area neat
Reagent preparation
Perform task accurately
Perform task timely
Other: Specify
Direct Observation
checklists
Indirect Observations
monitoring records
re-testing
case studies
Give previously analyzed specimens for testing
Provide written exercises to assess:
Problem solving skills
Knowledge
Interpretation
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23. Policies and Processes
Policy writing- management responsibility
Review annually and modify when necessary
Processes
Who will conduct assessment?
When will assessments occur?
What will be assessed?
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24. Competency assessment documentation
use standard forms
date and keep confidential
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25. Training
Continuing Education
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26. Training Methods and Resources
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27. Performance Appraisal
professional behavior
customer service
communication
observation to safety
adherence to policy
competencies
Efficiency
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28. Performance Appraisal Meetings
formal
regular
constructive
objective
complete
fair
documented
J. Smith
Confidential
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29. Competency Assessment
Personnel Records
Performance Appraisal
Training Records
Competency Assessmen
Competency Assessment
John Smith
CONFIDENTIAL
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30. Summary
Personnel management is critical to success of a quality management system.
Job descriptions should accurately describe tasks and authorities.
Competency must be assessed.
Training will help to assure competent staff.
Methods for attracting and retaining personnel must be addressed. 30
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31. Key Messages
Personnel are the most important resource in the laboratory.
Managers must create an environment that will fully support all laboratory personnel in order to maintain a high quality of laboratory performance.
Continuing education is vital to personnel competency.
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32. Thank you
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