Laboratory Personnel
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Transcript of Laboratory Personnel
Laboratory Personnel
Dr/Ehsan Moahmen Rizk
Personnel-Module 12 2
Organization Personnel Equipment
Purchasing &
Inventory
Process Control
Information Management
Documents&
Records
Occurrence Management Assessment
Process Improvement
Customer Service
Facilities &
Safety
The Quality Management System
Personnel-Module 12 3
Success or failure of quality system is dependent on
the laboratory staff
Knowledge and skills
Motivation
Commitment3
Laboratory StaffYOU 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
Personnel-Module 12 44
Continuing Education
Training
Job Descriptions
Orientation
Competency Assessment
Job Qualifications
Personnel Management
Personnel-Module 12 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
Orientation
Competency Assessment
Task-specific Training
Competency Recognition
Job Description
Qualified New Employee
Retraining
Personnel-Module 12 8
Orientation
Personnel-Module 12 99
Competency Assessment
Job Description
Task-specific Training
Competency Recognition
Retraining
Personnel-Module 12 10
Laboratory director
1. provide advice to those requesting information about the choice of tests, the use of the laboratory service and the interpretation of laboratory data
2. 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)
3. Define, implement and monitor standards of performance and quality improvement of the medical laboratory service
4. 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)
5. 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;
6. implement a safe laboratory environment in compliance with good practice and applicable regulations
Personnel-Module 12 13
Laboratory Manger
1. Responsible for the day-to-day management of the testing laboratory
2. Ensuring that there are enough personnel with adequate training and experience to conduct the work
3. 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)
4. 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
5. Taking all corrective actions that may be necessary to maintain satisfactory operation and performance of the laboratory
6. 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:
1. Management support of all laboratory personnel by providing them with the appropriate authority and resources to carry out their duties;
2. 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
3. Policies and procedures for ensuring the protection of confidential information
Personnel-Module 12 16
QA manger (continue)
4. The organizational and management structure of the laboratory and its relationship to any other organization with which it may be associated
5. Specified responsibilities, authority, and interrelationships of all personnel
6. Adequate training of all staff and supervision appropriate to their experience and level of responsibility by competent persons
7. 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
1. 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
2. Preparing specimens and samples
3. Constructing, maintaining and operating standard laboratory equipment
4. Ensuring the laboratory is well-stocked and resourced
Personnel-Module 12 18
Lab. Technician (continue)
1. Recording the results and conducting them to lab manger
2. using computers and performing mathematical calculations for test results
3. keeping up to date with technical developments, especially those which can save time and improve reliability;
4. Helping lab manger in conducting searches
5. 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:
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
•Problem solving skills
•Knowledge
•Interpretation
Personnel-Module 12 23
Policies and Processes
Review annually and modify when necessary
Processes
Policy writing-management responsibility
Who will conduct
assessment?
What will be assessed?
When will assessment
s occur?
Personnel-Module 12 24
Competency assessment documentation
use standard forms date and keep
confidential
Personnel-Module 12 2525
Training
Continuing Education
Personnel-Module 12 2626
Training Methods and Resources
Personnel-Module 12 2727
Performance Appraisal
professionalbehavior
professionalbehavior
customer service
customer service communicationcommunication
observation to safety
observation to safety
adherence to policy
adherence to policy
competenciescompetencies
Efficiency
Personnel-Module 12 2828
Performance Appraisal Meetings
formal regular constructive objective complete fair documented
Personnel-Module 12 29
Personnel Records
Performance Appraisal
Performance Appraisal
Competency Assessmen
CONFIDENTIAL
John Smith
Training Records
Competency Assessment
Personnel-Module 12 30Personnel-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.
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 3232