Laboratory Personnel
Dr/Ehsan Moahmen Rizk
The Quality Management System
Personnel-Module 12
Organization
Personnel
Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Management
Assessment
Process
Improvement
Customer
Service
Facilities
&
Safety
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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
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 Commitment
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Job
Qualifications
Continuing
Education
Job
Descriptions
Personnel
Management
Orientation
Competency
Assessment
Training
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Motivated employees are more
committed to their work
 praise
 recognition
 bonuses
 benefits
 flexible time
…
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Job Descriptions
“Laboratory Management
shall
have job descriptions that
define qualifications and
duties
for all personnel.”
ISO 15189:2007
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Qualified New Employee
Job Description
Orientation
Task-specific Training
Retraining
Competency Assessment
Competency Recognition
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Orientation
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Job Description
Task-specific Training
Retraining
Competency Assessment
Competency Recognition
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Laboratory director
1.
2.
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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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;
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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
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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
standard operating procedures
complete, up-to-date, available for
performing tests, and followed
personnel
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manual of
that are
personnel
by those
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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,
reporting of test results
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interpretation,
and
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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
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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,
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
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authority,
and
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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
laboratory equipment
and
operating
standard
4. Ensuring the laboratory is well-stocked and resourced
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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
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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
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records
of
equipment
and
lab
supplies
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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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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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Competency Assessment Methods

Direct Observation

checklists
Technologist Name
Procedure for
Evaluation
Procedure item

Indirect
Observations



monitoring records
re-testing
case studies
Technologist Title
Evaluation Date
Accept
Partial
Evaluator
No
Comment
Read procedure
manual
Equipment set up
appropriately
Work area neat
Reagent preparation
Perform task
accurately
Perform task timely
Give previously analyzed
specimens for testing
Other: Specify
 Provide written exercises
to assess: •Problem solving skills

•Knowledge
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•Interpretation
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Policies and Processes
Policy writingmanagement
responsibility
Review
annually and
modify when
necessary
Processes
Who will
conduct
assessment?
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What will
be assessed?
When will
assessments
occur?
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Competency assessment documentation
use standard forms
 date and keep
confidential

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Training
Continuing Education
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Training Methods and Resources
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Performance Appraisal
competencies
professional
behavior
observation
to safety
Efficiency
customer
service
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adherence
to policy
communication
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Performance Appraisal Meetings
 formal
 regular
 constructive
 objective
 complete
 fair
 documented
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Personnel Records
Training Records
Performance
Appraisal
John Smith
Competency
Assessment
Competency Assessmen
CONFIDENTIAL
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Summary

Personnel management is critical to
success of a quality management system.

Job
descriptions
should
describe tasks and authorities.

Competency must be assessed.

Training will help to assure competent
staff.

Methods for attracting and
personnel must be addressed.
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accurately
retaining
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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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