Lec.

1 Laboratory
Laboratory is a place that is equipped with different instruments, equipment ~and chemicals (reagents) etc., for
performing experimental works, research activities and investigative procedures. Medical laboratory is one part of the
laboratory that is equipped with various biomedical instruments, equipment, material and reagents (chemicals) for
performing different laboratory investigative activities by using biological specimens (whole blood, serum, plasma, urine,
stool, etc.).

Medical laboratory science

is a complex field embracing a number of different disciplines such as Microbiology, Haematology, Clinical Chemistry,
Urinalysis, Immunology, Serology, Histopathology, immunohematology and Molecular ‘biology and others.

Classification of medical laboratories

The world Health Organization (WHO) lists four kinds of levels of laboratories based on their biosafety

1- Basic laboratory level I

Basic laboratory level I is the simplest kind and adequate for work with organisms which have low risk to the individual
laboratory personnel as well as to the members of the community. These organisms are unlikely to cause human diseases.
Example, food spoilage bacteria, common molds and yeasts.

2- Basic laboratory level II

Basic laboratory level II is suitable for work with organisms that predispose to moderate risk to the laboratory worker and
a limited risk to the members of the community. They can cause serious human diseases but not serious hazards due to the
availability of effective preventive measures and treatment. Example, staphylococci, streptococci, entero bacteria except
Salmonella typhi and others. Such laboratory should be clean, provide enough space, have adequate sanitary facilities and
equipped with autoclave.

3- Containment laboratory (Level III)

Containment laboratory is more advanced and it is used for work with infectious organisms that present a high risk to the
laboratory personnel but a lower risk to the community. Example, Tubercle bacilli, Salmonella typhi, HIV, Yersinia and
others. The principle is to remove from the basic laboratory those organisms and Activities which are particularly
hazardous. They are easily transmitted through airborne, ingestion of contaminated food or water and parenterally- Such
laboratory should be a separate room with controlled access by authorized staff. It should also be fitted with microbial
safety cabinet.

4- Maximum containment laboratory

Maximum containment laboratory is intended for work with viruses, with predispose to a high risk for both laboratory
personnel and the community. Example, Small pox, Ebola, Lassa fever and others. Most of these organisms cause serious
disease and readily transmitted from on person to another. These laboratories are usually a separate building with strictly
controlled access.

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Laboratory Design Considerations
l. The laboratory shall be bound by four walls and a roof or ceiling.

2. Design for adjacent spaces for storage and consumption of food and drink as needed.

3. Design laboratory workstations to accommodate the range of body dimensions that may be using the workstations. For
workstations may require height-adjustable Work surfaces and chairs. Example, computer and microscopes

4. Each laboratory using hazardous materials, whether chemical, biological, or radioactive, should contain a sink for hand
washing.

5. All work surfaces (e.g., bench tops, counters, etc.) should be impervious to the chemicals and materials used in the
laboratory.

6. The laboratory shall be designed so that it can be easily cleaned. Bench tops should be of a seamless one-piece design
to prevent contamination. Penetrations for electrical, plumbing, and other considerations should be completely and i
permanently sealed. Lf the bench top abuts a wall, it should be covered or have a backsplash against the wall.

7. The walls shall be non-porous and painted with a durable, impervious finish to facilitate decontamination and cleaning.
High gloss paint is recommended.

Hospital lab types

. Chemistry: Chemistry performs a wide variety of tests using the most current technology‘
. Haematology: Haematology is the study of blood, blood morphology and blood diseases.
- Microbiology:
- Transfusion Services/Immunology:
- Immunology:
- Surgical Pathology:
- Cytology

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 LEC. 2 The role of lab
What is medical microbiology laboratory?

The Microbiology Laboratory is composed of several sections including Aerobic.

The Microbiology Laboratory is one of many labs in H95Pltal: The main purpose of this laboratory is to assist in the
diagnosis of infectious diseases, The patient‘s physician then orders specific tests to clarify the presence 0f an infectious
disease’

What is the infection control in microbiology?

They include detection of outbreaks of hospital-acquired infections, screening for Multi-resistant organisms, advice to
clinicians about disinfection, sterilization and isolation procedures, and the rational use of antibiotics. Clinical
microbiologists work closely with infection control nurses

What is a clinical microbiology laboratory? '

The Clinical Microbiology Laboratory is a full-service laboratory offering diagnostic bacteriology, Mycology,
parasitology, virology, and mycobacteriology.

Clinical microbiology is a discipline that incorporates testing for a diverse group of microorganisms

What is the role of microbiologist in hospital?

Medical microbiologists provide services to aid the diagnosis and management of infectious diseases and help ensure the
safety of those at risk of acquiring infectious diseases, both in hospitals and the community. Although this role is
laboratory-based, the microbiologist's role is increasingly clinical

What is the difference between medical microbiology and clinical microbiology?

Clinical microbiology is the study of any microbes which cause infection in humans.

Medical microbiology is a branch of medical science concerned with the prevention, diagnosis and treatment to
infectious diseases

What is microbiology and why is it important?

Fundamental understanding of how a cell works has come through the study 0f microorganisms. But microbiology also is
an applied science, helping agriculture, health and medicine and maintenance of the environment, as well as the
biotechnology industry. Microorganisms are extremely important in our everyday

Why do we need microbiology?

Microbiology is the study of microorganisms including, bacteria, v-viruses, 81268, Fungi and protozoa. Microorganisms
are most famous for their ability to cause disease, however, microorganisms are also vital to agriculture, ‘industry and
ecology. In fact, life on Earth would not survive without microorganisms

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Clinical role of the microbiology laboratory.
l— Patient diagnosis and management.
2- Specific issues of HAls. ,
3— the challenges 0f microbiological specimens.
4- Requirement /non-clinical specimens for microbiological analyses. '
5- Quality assurance systems.
6- Microbiological laboratory methods.
7- The challenges of consolidated microbiology laboratory,
8- Future developments.
9 -Point of care (POC) test
THE LABORATORY AND INFECTION CONTROL
Infection control is the discipline concerned with preventing nosocomial or healthcare-associated infections.

It is about identifying and controlling the factors involved with the spread of these infections, whether from patient-to-
patient, from patients to staff, from staff to patients, or among-staff. These factors include

1- Prevention (via hand hygiene/hand washing, Cleaning / disinfection / Sterilization, vaccination, surveillance)
2~ monitoring investigation of demonstrated or suspected causes for spread of Infection within a particular healthcare
setting. -.
3- The surveillance, investigation, and management of outbreaks. It is on this basis that the more common title being
adopted within health care is “infection prevention and control.’
Hospital-acquired infections are an important category of hospital-acquired conditions. HA1 is sometimes expanded as
healthcare-associated infection to emphasize that infections can be correlated with health care in various settings (besides
hospitals, such as nursing homes), which is also true of hospital-acquired conditions generally.

The CDC, through its guidelines development, nosocomial infection surveillance methodology, outbreak investigations,
and laboratory studies, has provided much of the scientific and epidemiologic basis for infection control in the United
States’ also organized some of the early training for infection control programs and hospital epidemiologists.

Surveillance of Nosocomial Infections

Surveillance which is an essential element of an infection control program1 provides the data to identify infected patients
and determine the site of infection and the factors that contributed to the infection. When infection problems are
recognized, the hospital is able to institute appropriate intervention measures and evaluate their efficacy Surveillance data
are also used to assess the quality of care in the hospital.

The microbiology Laboratory contributes to the work of the Infection Control Program by fulfilling its
technical responsibilities by performing quality microbiology investigations through:
- Proper Specimen Collection
- Accurate Identification and Susceptibility Testing
- Laboratory Information Systems for comprehensive information /ordering
- Rapid Diagnostic Testing
- Rapid reporting of Laboratory Data
- Outbreak Recognition and Investigations ~ Molecular Typing
- Maintaining Organism Storage
- Maintaining Cultures of Specimens from Hospital Personnel and the Environment

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The microbiology laboratory ‘should be involved in all aspects of the infection control program. Particularly important
are its roles in the hospital ‘Infection surveillance, as well as assisting the infection control program to effectively and
efficiently utilize laboratory services for epidemiologic purpose; equally important is the quality of the technical work
performed, and the expertise provided.

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 Lec.3 Clinical Laboratory Manager
Clinical laboratory managers, a more advanced position among clinical laboratory technicians and technologists, work in
and oversee the operations of medical testing laboratories. They work in private and government labs, hospitals, and
clinics. Duties of clinical laboratory managers include managing overall lab operations; developing procedures to ensure
safety,security,quality, and accuracy of results; designing and performing test procedures;analyzing requests for tests and
equipment; tending to administrative and management matters; consulting with principal investigators; and assisting in
budgeting.

Lab managers bring together their managerial skills and knowledge of safety and lab procedures to ensure that
laboratories operate smoothly. Managerial duties generally include scheduling staff, reordering supplies, and maintaining
security standards.

What are the principal responsibilities of the laboratory director?

The laboratory director is responsible for the overall operation and administration of the laboratory, including the
employment of personnel who are competent to perform test procedures, record and report test results promptly,
accurately and proficiently, and for assuring compliance with the applicable regulations.

Required Education and Licensing

While it may be possible to become a clinical laboratory manager with a 4-year bachelor's degree and relevant experience,
many positions require applicants to have a master's degree in a field like microbiology, medical technology or public
health administration. Common coursework in a bachelor's degree program or 2- year, master’s degree program that
would qualify you to work in clinical laboratory management includes anatomy, biochemistry,
mathematics,statistics,public health,epidemiology,biostatistics,and health care management.

Skill Requirements
Clinical laboratory managers need to be knowledgeable in both medical technology and management principles to be
effective in their positions. Working well as part of a team, a good work ethic, and strong communication skills will also
serve you well if you hope to become a clinical laboratory manager.

Other options in this field include: .

Chemical Technician
A chemical technician participates in hands-on research in chemistry under the direction of senior researchers. Chemical
technicians use the knowledge and skills they've gained through associate's degree programs in applied science
particularly lab skills to prepare samples for testing, observe chemical reactions, analyze results, and share findings with
others.

Biological Technician
Biological technicians need to have a bachelor's degree in a biological sciences field with an emphasis on lab work for
employment. They help carry out experiments under the supervision of senior research team members. They prepare
experiments, measure or observe samples, analyse the results, and prepare reports. Biological technicians can work in
microbiology, biotechnology, industrial production and mining, or natural resource management, among other fields. A
graduate degree and experience may be needed for career advancement.

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Main Categories of Laboratory Management
1-Laboratory planning: The planning and documents comprise the process flow (analytics), the needed laboratory
equipment as well as the laboratory furniture, the utilities supply, balance of energy, the concept for the rooms/building
Planning allows a laboratory manager to know where the lab is going

2-Organization: The term organization in the context of a quality management model is used to indicate the management
and the supporting organizational structure of the laboratory. Organization is one of the essential elements of the quality
system, and is intimately related to all the other elements in the model.

3Leadership is extremely important for a lab manager, as it often sets the environment and pace of the lab. Good
leadership can inspire laboratory staff members toward productivity and creativity and help members work together.

4-Controlling a laboratory involves the evaluation of laboratory staff members and projects progress, and the ability to
correct problems as they arise.

5-Know the legal restrictions (and advantages) of a healthcare laboratory in your country.

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LEC 4
Mission of the Laboratory Services
What is the role of clinical laboratory personnel in patient care?
The role of a clinical laboratory is to promptly provide highly reliable laboratory data to satisfy the needs of clinicians
involved in medical practice and health maintenance of patients Improvement and maintenance of the quality of the
laboratory staff and environment are essential to achieve this goal
How the lab helps in health care system?
Laboratory information enables physicians and other healthcare professionals to make appropriate evidence-based
diagnostic or therapeutic decisions for their patients. Clinical laboratory ‘services are the most cost effective, least
invasive source of the objective information used in clinical decision-making
Mission of the Laboratory Services
To improve the health status of Sample Country through providing quality service by advancing the capabilities of all
laboratories in laboratory technology, related public health disciplines, training, research and well-motivated staff

CLINICAL LABORATORY SERVICES IN HEALTH CARE

, Clinical laboratories provide information and services that contribute to maximizing the effective delivery of care in
today's complex healthcare system by assuring that the correct test is performed on the right person, at the right time,
producing accurate test results that enable providers to make the right diagnostic and therapeutic decisions using the
right level of health care resources,
Laboratory information enables physicians and other healthcare professionals to make appropriate evidence based
diagnostic or therapeutic decisions for their patients. Clinical laboratory services are the most cost effective, least
invasive source of the objective information used in clinical decision-making. Clinical laboratory services have a direct
impact on many aspects of patient care including, but not limited to, length of stay, patient safety, resource utilization,
and customer satisfaction,
While technology continues to improve the productivity of today's laboratories, new technologies, new diseases, and
disease strains continue to drive the need for more tests and testing. Changes in the world, such as bio-terrorism and the
speed With which diseases spread globally drive the need for rapid diagnosis. Thus, the clinical laboratory professional
is an indispensable partner in providing patient care, and making direct improvements in the lives of patients, in the
maintenance of the public‘s health, and in the effectiveness of individual health care providers

Rationale
Impacting diagnosis, identifying Abnormalities: Laboratory professionals produce accurate, sensitive and specific
information using new age technologies to guide clinical decision making. It is the role of laboratory professionals to
inform physicians about which tests have the highest effectiveness in given clinical conditions. Through this
partnership, the overall cost of testing and patient care is controlled and the quality of care is improved.

Laboratory information has a profound impact on patient diagnosis. Tests, whether classified as screening or diagnostic,
are essential elements of protocols used to diagnose and manage specific diseases and conditions. Algorithmic testing
models, designed with clinicians, are used to guide the diagnostic process to obtain the right information at the right
time for a given patient, shorten the time to diagnose, the length of stay and improve utilization of laboraton/ services.‘
These models assist in rapid identification of disease, assessment of severity of disease, creation of a therapeutic plan,
and management/monitoring of treatment outcomes. The more efficient the testing protocol, the shorter the length of
inpatient stay or outpatient encounter, the faster the implementation of therapy, and the lower the overall cost of care.

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Change in patient management: The ability of a physician or other patient care provider to consistently make timely
and evidence-based decisions which result in a change in care management is directly related to the availability 0f
accurate, reliable and timely laboratory testing and reporting of results. A few examples that illustrate the laboratory
professional's ability to be the primary enabler of therapeutic efficacy are:

• Monitor the effectiveness of parenteral nutritional treatment

• Ensure proper dosing of medication
• Monitor harmful effects of therapeutic drugs’
• Identify the causes of infection
• Determine effective antibiotic therapy
• Monitor the effectiveness of cancer therapy
• Provide real-time decision support

Clinical laboratory services provide the information required by a physician to start, adjust and also to stop a course of
treatment. This allows for the most appropriate, cost effective use of expensive drugs and other therapies, and allows the
patient to be treated at the most appropriate level of care for the most appropriate period 0f time. Without laboratory
information, these decisions would be compromised at best. _

Patient Safety and Impacting Patient Outcome: Clinical laboratory services are a vital component of ensuring
optimal outcomes for all patients accessing health care, whether for simple situations or for complicated, potentially life
threatening situations; including end-of-life care. Laboratory professional’s impact patient safety by providing pre-
surgical or pre-procedural testing that determines the current ability of the patient to undergo those treatments. Patient
outcomes are influenced by providing the needed information for clinicians to monitor the effectiveness of ongoing
treatments and therapies. Patient outcomes can also be measured by how well chronic illnesses are managed. Diabetics
rely on laboratory support to monitor the long-term effectiveness of their home monitoring systems. Laboratory
professionals provide vital information to assist clinicians in making decisions that affect quality of life for their
patients.
How do public health laboratories differ from clinical laboratories?
Public health laboratories focus on diseases and the health status of population groups. They perform limited
diagnostic testing, reference testing, and disease surveillance. They also provide emergency response support, perform
applied research, and provide training for laboratory personnel

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LEC. 5, 6
Planning and organization

Efficient medical laboratory planning and design can increase productivity, leading To faster turnaround times and
better patient outcomes.

Well-organized medical laboratory setup design requires a synergistic approach to many elements that affect space,
work flow equipment, ventilation, lighting, plumbing, electrical systems, and communications. The benefits of a
thoughtfully constructed and arranged works ace are multifaceted. The laboratory can be. Optimized by keeping day-to-
day task specifics in mind. This allows for efficient process performance, safety, and sustainability.
Choosing a medical laboratory planning and design team should be the first step in the process of redesigning or
building a new laboratory. The team should include a group of staff members who are familiar with the laboratory, the
facility, architecture, and engineering. Representatives from laboratory administration, laboratory staff, pathology staff,
hospital and/or organization administration, and the facilities department should make up the team.

The team should participate in a planning phase to collect information necessary to ensure that the contraction process
and resulting laboratory will work smoothly and efficiently. An analysis of the existing workflow design should be
conducted at the beginning of this phase and existing processes should be reviewed to ensure they are as efficient as
possible. Organization In order to have a functioning quality management system, the structure and management of the
laboratory must be organized so that quality policies can be established and implemented. There must be a strong,
supporting organizational structure-management commitment is crucial; and there must be a mechanism for
implementation and monitoring.
Laboratory planning and organization

It is essential that the individual responsible for laboratory management be able t0 plan and organize laboratory services
and, as a necessary prerequisite, training should encompass the following:

❖ Implementation—implementation requires that a number of issues must be addressed by the management staff
These include management of projects and activities, directing resources to accomplish plans, and ensuring that
timeliness are met and goals achieved
❖ Monitoring—as components of the quality management system are put in place, processes for monitoring will
be needed to ensure that the system is working, and that benchmarks and standards are being met, This element
is essential to the primary goal of a quality system, which is continuous improvement.

Organizational Structure

The Organizational Structure needs to be clearly defined. To avoid assumptions,

o Organizational chart should be drawn up with the responsibilities at all levels clearly defined,
o Assignment of responsibility
o The management team is responsible for strategic planning
The planning process should be based on the vision and goals set.

When considering organizational structure to support a quality management system, a number of elements should be
considered: El The path of workflow is the route of a sample through the laboratory, from collection to reporting of a
result. The organizational structure of the laboratory must support an optimal path of workflow, by allowing processes
that yield efficient sample handling while minimizing error. Considerable attention should be given to the design of this
systems

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 ❖ An accurate and complete organizational chart is necessary, Many problems can be prevented if responsibilities
are clearly defi ned and all members of the laboratory team understand what each is supposed to do.

Organizational functions: planning

Once management is committed to instituting a quality system in the laboratory, a planning process is needed,
Approaches used will vary, depending on many factors

1. Structure of health Services in the country of the trainee, current national policy, priorities and resources
2. Classification of laboratories (for example, primary, intermediate, specialist)’ interactions between types of
laboratory, functions of the a laboratory’ management, screening, education and research and development.
3. Definition of workload and influencing factors, for example, local spectrum Of diseases, expertise of clinical
staff, availability of laboratory staff and equipment, type of population served-~paediatric, adult, aged, chronic
sick, acutely diseased, etc., assessment of workload using performance indicators, for example, unit values,
number of requests and test per request ratio.
4. Strategies for organization of the laboratory; benefits and disadvantages of‘ discretionary and profiling
approaches, problems associated with biochemical screening, analytical equipment operated by non-laboratory
personnel outside the laboratory (including local regulations, medical requirements, equipment and range of
analyses available, training of analysts and quality assurance).
5. Organization of work flow, including the collection and transportation of specimens; identification of specimens
and samples using color codes, unique numbers, bar codes and other methods, distribution of specimens
throughout the laboratory, work simplification techniques, referral of specimens to other laboratories.

The important organizational requirements for achieving a successful quality system include the following:

Leadership—laboratory leaders must be fully committed to implementation of the system, and these leaders
will also need vision, team-building and motivational skills, good communication techniques, and the ability to
use resources responsibly.
Organizational structure—the structure of the organization should be clearly defined, and this should be
reflected by a functional organizational chart with clear assignment of responsibility.
Planning process—skills for planning are needed, and planning should address a time frame, responsibility for
conducting the activities, the availability and use of human resources, management of workflow and financial
resources.
in the local situation.
What quality practices are already in use in the laboratory?
What is the level of knowledge of current staff?
What resources will be available?

All elements of the quality system should be included in the planning process. It is not necessary (usually not possible)
to implement all parts of the plan at once; a stepwise approach will often be more practical.

In many laboratories, the implementation of a quality system may involve many changes. It is therefore important to
keep all staff involved, and to not proceed too rapidly, as personnel May find it difficult to meet the goals and can get
discouraged. Communicate with staff frequently, clearly and positively; this will help to keep morale high.

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During planning, priority areas will emerge as the bigger problems are identify ed. It will be important to keep
objectives realistic and measurable. Inevitably, there will be some factors that are beyond the control of the laboratory.
Recognize these and move on to other factors that can be addressed. If these factors are vital to the ultimate success of
the quality programme, then look for ways to influence those who can control them. Always advocate for quality.

In planning for implementation of a quality system, the first step is to analyse and understand the current practices. A
useful way to accomplish this is the technique of gap analysis. To conduct a gap analysis: El use a good quality systems
checklist to evaluate the practices in the individual laboratory; to identify gaps or areas where the laboratory is not using
the good laboratory practices required in the Quality system.

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LEC 7
MEDDICAL DIRECTOR OF LABORATORY RESPONSIBILITIES AND ROLE
director’

Who is a laboratory Director?

According to CLIA regulations’ ‘the CML director responsible for overall operation and administration of the
laboratory- this include employment of personnel who are competent to perform test procedure and record and report
test result promptly personnel to proficiently accurately, and proficiently

What does a laboratory director do? _

The laboratory director is responsible for the overall operating and administration of the laboratory, including the
employment 0f personnel who are competent to perform test procedures, record and report test results promptly,
accurately and proficiently, and for assuring compliance with the applicable regulation '

How do you become a lab manager?

Education Needed to Become a Laboratory Manager Typically, to become a laboratory manager, you first need to obtain
a bachelor of science in the appropriate field‘For example, those looking to work as a pharmaceutical lab manager
should obtain an undergraduate degree in biochemistry or pharmacy
THE MEDICAL LABORATORY DIRECTOR
The medical director of the laboratory is a suitably qualified physician who is legally, morally, and ethically responsible
for the scope, standards, and quality of service. The medical director has the knowledge and skills in all areas of practice
which includes administration, teaching and education, research, and patient care. The director stands responsible for
medically useful, accurate information made available in a timely fashion to enhance medical services t0 patients. The
director participates in all managerial decisions and guides the operation of the laboratory ranging from selection of
staff, choice of methods, purchase of equipment, quality assurance, quality control, safety, hours of operation,
scheduling of staff, and utilization management.

The Director Shall be :

Have sufficient authority to implement and maintain the standards
define and monitor accepted standards of performance and direct the implementation of laboratory Services
function as a peer member of the medical community
support medical Staff functioning as in integrated team, personally demonstrating leadership and team qualities
Assist in the interpretation and correlation of laboratory data for patient management '
establish short and long term goals and allocate the appropriate resources
provide cost-effective administration of all laboratory services
provide educational direction for the medical and laboratory staff
communicate effectively with accrediting, licensing, and regulatory bodies and maintain effective
communication with the local board of directors of the hospital or institutional administration

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THE ROLE OF THE DIRECTOR AS SERVICE PROVIDER

There are some roles include :

l. Medical significance, interpretation, and correlation of data. Make judgments about the medical significance of
clinical laboratory data and communicate effectively in interpreting laboratory data and relating correlations to referring
physicians as appropriate.
2. Direct Service
Personally perform a variety of services expected of a laboratory physician, e.g.: surgical pathology, autopsies, frozen
sections, bone marrows, needle biopsies, etc.
3. Consultations
Provide consultations to physicians regarding the medical significance of laboratory findings and utilization of the
laboratory as appropriate.
4. Medical Staff Privileges
Serve as a member of the medical staff as appropriate, for those facilities sewed
5. Appropriate and Timely Service
Stand responsible for the appropriate and timely response of the laboratory to physicians requests for testing plus the
appropriate and timely reporting of results. Document compliance with national or provincial utilization protocols
pertaining to laboratory services.
6. Quality Assurance Responsibilities
Assure that the laboratory participates effectively in the quality assurance program of the institute.
7, Personnel
Ensure that are sufficient qualified personnel with adequate training and experience to supervise and perform the work
of the laboratory.
8. Strategic Planning, .
Perform planning for setting goals and allocation of resources appropriate to the medical enviromnent. (Where
appropriate in conjunction with the medical staff and administration of the hospital or institution).

PERSONNEL

l. Staff Complement
There shall be a sufficient number of qualified laboratory physicians, laboratory technologists, technicians, and other
laboratory staff to perform the. Required tests promptly and efficiently. Staff morale should reflect reasonable
workloads
2. Staff Qualifications
The director shall assure that all procedures and tests performed by the medical technical staff are within the scope of
education, training, and experience of the individual(s).
3. Staff Scheduling
Qualified technical staff shall be on duty, or available, at all times that laboratory testing is being performed.
4- Staff Education
Provision shall be made for all personnel, including physicians and supervisors, to further their knowledge and skills
through on-the-job training, in-service education programs, or attendance at workshops, institutes, and/or professional
meetings. In-service education programs shall be provided at defined intervals appropriate for the size and needs of the
technical staff.
5. Staff Orientation
An adequate orientation program must be in place. Documentation of activities should be maintained.

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