Laboratory Personnel

1. Laboratory Personnel Dr/Ehsan Moahmen Rizk

2. Organization Personnel Equipment Purchasing & Inventory Information Management Documents& Records Occurrence Management Process Improvement Customer Service Facilities & Safety The Quality Management System Process Control Assessment Personnel-Module 12

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 Personnel-Module 12 3

4. Job Qualifications Personnel Management Competency Assessment ContinuingEducation Job Descriptions Orientation Training Personnel-Module 12 4

5. Motivated employees are more committed to their work • praise • recognition • bonuses • benefits • flexible time • … Personnel-Module 12

6. Job Descriptions “Laboratory Management shall have job descriptions that define qualifications and duties for all personnel.” ISO 15189:2007 Personnel-Module 12

7. Qualified New Employee Job Description Orientation Task-specific Training Retraining Competency Assessment Competency Recognition Personnel-Module 12

8. Orientation Personnel-Module 12

9. Job Description Task-specific Training Retraining Competency Assessment Competency Recognition Personnel-Module 12 9

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 Personnel-Module 12

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; Personnel-Module 12

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 Personnel-Module 12

13. 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 Personnel-Module 12

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 Personnel-Module 12

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 Personnel-Module 12

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 Personnel-Module 12

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 Personnel-Module 12

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 Personnel-Module 12

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 Personnel-Module 12

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. Personnel-Module 12

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. Personnel-Module 12

22. Competency Assessment Methods • 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 Personnel-Module 12

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? Personnel-Module 12

24. Competency assessment documentation • use standard forms • date and keep confidential Personnel-Module 12

25. Training Continuing Education Personnel-Module 12 25

26. Training Methods and Resources Personnel-Module 12 26

27. Performance Appraisal competencies professionalbehavior adherence to policy observation to safety communication customer service Efficiency Personnel-Module 12 27

28. Performance Appraisal Meetings • formal • regular • constructive • objective • complete • fair • documented J. Smith Confidential Personnel-Module 12 28

29. Personnel Records Performance Appraisal Training Records Competency Assessmen Competency Assessment John Smith CONFIDENTIAL Personnel-Module 12

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 Personnel-Module 12 Personnel-Module 12

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. Personnel-Module 12

32. Thank you Personnel-Module 12 32