Laboratory personnel and their

roles
Ms. HD Lumeesha Yadeeshani
BSc (Hons) in Medical Laboratory Sciences
Reading for MSc in Cellular and Molecular Immunology
Intended Learning Outcomes (ILOs)

At the end of this lecture, students should be able to;

• describe and understand the organizational structure of a Medical

Laboratory.
• describe the laboratory staff and their responsibilities.
• describe the laboratory consultation and supervision.
• explain the importance of personnel training and management.
• outline the ethical conduct of a medical laboratory.
• outline the documentation requirements.
Organizational structure of a Medical Laboratory

What to do? Policies

Top level

How it Processes
Middle level happens?

How to do Procedures
Low level it ?
 Head of the laboratory-
Managing Director
Histopathologist

Management Manager/s (Operation

& Business)
structure – Haematologist

Top level Consultants

Management Microbiologist
Principle scientific
officer
Chemical Pathologist
Management structure – Middle level
Management
Sectional technical head
• Histopathology
• Haematology
• Microbiology
• Chemical Pathology

Safety officer

QC officer/ Manager

Computer and data processing supervisor

 Medical laboratory Technical
staff

Phlebotomists
Management
structure – Clerical staff
Low level
Management
Laboratory assistants

Labours
Laboratory director
• The laboratory shall be directed by a
person or persons with the
competence and delegated
responsibility for the services
provided.
• 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
• 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.

• 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.
Laboratory Manager
• 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.
• Maintaining a quality assurance program to
assure the proper performance and
reporting of all test results.
• Responsible for review, interpretation, and
reporting of test results.
• Assuring and documenting the validity,
reliability, accuracy, precision, and
performance characteristics of each test
and test system.
Consultants
• Clinical laboratory consultants
monitor lab operations in a hospital
or private lab.
• Their primary responsibilities
include assisting with the set up of
new clinical research, creating
procedural guidelines, and
overseeing testing to ensure the
experiment follows safety
standards and regulatory
requirements.
• Review lab information to check
that the laboratory staff used
proper analytical performance
methods on all testing.
Sectional technical heads
(Senior Lab Technician)
• Assist the laboratory
administration.
• Supervise other lab technicians,
supportive staff and minor staff.
• Allocation of duties and compile
duty roster
• Maintain inventories (Instrument,
reagent &consumables)
• Maintain laboratory statistics and
other records
• Educate other lab technicians
• Participate QC programmes
Quality manager
• Implement the QA program
• Generate data and provide day-to-
day documentation
• Should receive training in QA
procedures
• Attitude toward QA should be part
of annual performance appraisal.
Safety officer
• Responsible for implementing,
monitoring and assessing all the
laboratory safety protocols in the
laboratory.
• Implementation of awareness
programme about lab safety
protocols for the laboratory staff.
• Documentation of safety
procedures.
Medical Laboratory Technologists

• Perform laboratory tests

• Operation, calibration and
maintenance of laboratory
equipment
• Maintain records of laboratory
investigations.
• Performs quality control tests.
• Take part in teaching and
training programs
Phlebotomist
• A Phlebotomist is trained to
take blood samples from
patients in a medical
setting and transfer them to
the appropriate
laboratories for testing.
• Their duties include
preparing the testing room
with the proper tools,
keeping patients calm
while drawing blood and
labeling samples for further
analysis in medical
laboratories.
 Supportive staff/ minor staff

• Assist in cleaning, maintaining

laboratory equipment to ensure
accuracy and reliability in experiments
and tests

• Supportive staff may handle specimen

collection, labeling, and transport
within the laboratory, following proper
protocols to prevent contamination or
errors.

• Maintaining a safe working

environment by following safety
protocols, handling hazardous
materials appropriately
Personnel
management
and training
Personnel management and
training
• Job qualifications
• Job descriptions
• Laboratory technical staff
recruitment
• Orientation and training
• Competence assessment
• Continuing education
• Performance appraisal
• Documentation
Job qualifications

• Often established by the Ministry of Health

• Levels of education and training
• Advanced degree
• Degree
• Non-degree, formal technical training
• Bench training
General
skills and
abilities
• Problem solving
• Communication
(Written and oral)
• Mathematical
• Manual dexterity
• Color vision
Job descriptions

• Specify responsibilities and duties

• Reflect education, training and
experience
• Incorporate activities or tasks to be
performed
• Competency based – General skills
• Specify QA responsibilities
Laboratory
technical staff
recruitment
• Permanent staff
• Sub- contracting
(outsource tests)
• Part- time staff
• Sub - contracting
(outsource services)
 General orientation

• Organizational information
• Facilities
• Safety information
Orientation
and training Personnel Issues

• Ethics / confidentiality
• Benefits
• Emergency contacts
• Scheduling
• Introduction to the laboratory’s operations
• Overview of the Quality System –Responsibilities
• Technical procedures
• Initial competency assessment

Training programme are important aspect in laboratory personnel

management because,

• Jobs and technology changes

• New staff need special training
• Promoted staff need new skills
• It increases staff motivation and retention
• It increases staff efficiency
• It improves employee career prospects
• Staff become multi-skilled and can do more interesting jobs
Competency Assessment

• Competency:
Having the essential abilities to perform
specific tasks. Tasks involve procedures
throughout the specimen process.
• Competency Assessment:
Any system in place for measuring,
documenting, or otherwise determining
whether employees are able to do their job.
• Two approaches
• New Staff
• Current Staff
Continuing
education
• Important in achieving
good laboratory quality
• Individual personal
goals
• Nothing stays the
same!
• New tests
• New instruments
• New clinical programs
and drugs
Performance Appraisal

• Assessing overall job performance

• Factors to evaluate:
• Technical competencies
• Efficiency of accomplishing work
tasks
• Observance of safety rules
• Timeliness
• Communication skills
• Customer service
Documentation
• Personal details • Job description
• Employment details • Continuing education records
• Resume • Competency assessments
• Post held and dates
• Personnel actions
• Authorized areas of
testing • Work injury records
• Terms and conditions of
employment
Ethical
conduct
What is meant by ethical
conduct?
Ethics:
• A code of moral standards of conduct what is
“good” and “ right” as opposed to what is “bad”
or “wrong”.
Ethical behavior:
• That which is “right” or “good” in the context of
governing moral code.
• Ethical behavior is value driven.
 Ethical
conduct
Laboratory management shall have
arrangements in place to ensure the following:

There is no involvement in any activities that would

diminish confidence in the laboratory’s competence,
impartiality, judgement or operational integrity.

Management and personnel are free from any undue

commercial, financial, or other pressure and influences
that may adversely affect the quality of their work
Where potential conflicts in competing interests may
exist, they shall be openly and appropriately declared;

There are appropriate procedures to ensure that staff

treat human samples, tissues or remains according to
relevant legal requirements;

Confidentiality of information is maintained

Documentation
in a medical
laboratory
 Documents in a laboratory
Document management Document control
• Laboratory document control is
the systematic process of
• Laboratory document controlling laboratory
management is the process of documents and records
managing laboratory throughout their lifecycle.
documentation, from creation • Document control involves
to disposal. documentation review,
approval, tracking, submission,
• Laboratory document and versioning.
management focuses on the • Laboratory document control is
overall process of storing, important to ensure
managing, and distributing laboratories use only the most
documents. recent version of documents.
• Laboratory document control
• Effective laboratory document ensures everyone follows the
management is critical for most recent procedures and
maintaining data integrity, supports compliance with
relevant requirements.
traceability, and compliance.
Why is documentation important in medical laboratories?

• Documentation in laboratories is essential for ensuring the accuracy,

traceability, and reproducibility of laboratory results.
• Documentation provides a record of procedures, data, and
observations, supporting effective communication, and ensuring
compliance.
• Documentation supports data integrity by preventing errors, facilitating
audits, and providing evidence of adherence to SOPs and protocols,
thereby enhancing reliability and credibility.
• Moreover, thorough documentation allows for effective knowledge
transfer, continuity of operations, and continuous improvement
Types of Laboratory Documents

• Quality Manual
• Standard Operating Procedures (SOPs)
• Work Instruction
• Method
• Personnel Files
• Equipment Manual
• Safety Data Sheets (SDS)
• Supplier Qualification
• Proficiency Testing Plan
• Inventory Control Documents
• Certificate of Analysis (CoA)
• Risk Assessment Form
• Sample Submission Form
Types of Laboratory Records

• Laboratory Test Records

• Training Records
• Equipment Calibration Records
• Equipment Maintenance Logs
• Equipment Cleaning Records
• Sample Receipt and Log
• Patient Records
• Waste Disposal Records
• Incident Reports
• Audit Reports
• Quality Control (QC) Records
• Environmental Monitoring Records
Key procedures for laboratory document management.

• Procedure for document versioning

• Procedure for document access
• Procedure for document review
• Procedure for document approval
• Procedure for document distribution
• Procedure for document archiving and storage
• Procedure for document retention and disposal
• Procedure for control of external documents
 Summary
• Organizational structure of a Medical Laboratory (top level, middle
level and low-level laboratory personnels and their roles)
• Different aspects of personnel management and training.
• Importance of laboratory documentation process.
• Importance of ethical conduct in a medical laboratory.