DR RAYA EZAT LEC 4

V/lission 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 patientsi 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,

Laboratow information enables physicians and other healthcare

professionals to make appropriate evidencebased 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
Wmmmmme 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.

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 professionals 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

nee J t,

Planning and organization

~ ' ‘ rease roductivi , leading

Efficient medical laboratory planning and 116518“ can "1° P ‘y

tofastor tumaround times and better patient outcomes.

Well-organized medical laboratory setup design requires a synergistic approach to

many elements that affect space, WOFkflOW» equipment, ventilation, lighting, l

plumbing, electrical systems, and communications. The benefits of a thou 'tful

constructed and arran ed works ace are multifaceted. The laboratory can be .

optimized by keeping day-to-day task specifics in mind. This allows for effiment

process performance, safety, and sustainability. /_f1__)

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 coneruclioll 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:

’ 4~ Implementation—implementation requires that a number of issues must be

addressed by the management staffi These include management of projects and

activities, directing resources to accomplish plans, and ensuring that timelrnes

are met and goals achieved

U 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

g ‘g; that bgnchmarks 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,

an El Organizational chart should be drawn up with the responsibilities at all levels

clearly defined,

El Assignment of responsibility

U The management team is responsible for strategic planning

The planning process should be based on the vision and goals setr
Us by.“

When considering organizational structure to support a quality management

system, a number of elements should be considered: El The path of workfiow 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

.f systems

El 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 0n many factors

My ,

- ' of the trainee, current national policy,

l. Structure ofhealtll Services in the country

ll priorities and resources '/ “ r' “

- ‘ ' ' nd s ecialist '

2, Classification of laboratories (for example, anary, mtlezgnedtlflte ll diap osis )’

interactions between types oflaboratOl'y, functions ofthe a ora ory m gn ’

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-~pediatric, 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:

I] 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.

El 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.

Q Planning process—skills for planning are needed, and planning should address a

llme frame, tesponsrbillty for conducting the activities, the availability and use of

human resources, management of workflow and fi nancial resources.

V in the local situation. El What quality practices are already in use in the laboratory?

U What is the level of kriOWIedge of current staff? El 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 ofien 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 fi nd it diffi cult to meet the goals and can get

discouraged. Communicate with staff frequently, clearly and positively; this will

help to keep morale high.

During planning, priority areas will emerge as the bigger problems are identifi 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 infi uence those

who can control them. Always advocate for quality.

In planning for implementation of a quality system, the fi rst step is to analyze 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; I] identify gaps or areas

where the laboratory is not using the good laboratory practices required in the

quality system.

C 7 ES RESPONSIBILITIES AND

lIC'IlIEDICAL DIRECTOR OF LABORATORI

ROLE director’? bl f th o erall

Who is a laboratory ‘ - ' gnsi e 0|‘ e V

According to CLIA regulations’ ‘he CML direct¥;;: :csfildes employment of

operation and administration 0f the laboratory- d res and record and report test

personnel who are compeiem to perfoflti test proee u

results promptly, accurately, and proficiently

What does a laboratory director do? _

The laboratory director is responsible for the overall operathn and

administration ofthe laboratory, including the emplofim'lent 0f personnel who are

competent to perform test procedures, record and report test results promptly,

accurately and proficiently, and for assuring compliance with the appllcable

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 z

have sufficient authority to implement and maintain the standards

define and monitor accepted standards of performance and direct the

implementation of laboratory Services

I . 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
THE ROLE OF THE DIRECTOR AS SERVICE PROVIDER

There are some roles include :

l. Medical significance, interpretation, and correlation of data. Makejudgments

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' 52:33:11;ng 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 wrth 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.

4i 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.