LABMMLS LABORATORY MANAGEMENT

COVERAGE - (4) guide patient management; and

I. INTRODUCTION TO - (5) monitor efficacy of therapy
LABORATORY
MANAGEMENT/ QUALITY
WHAT IS MANAGEMENT
MANAGEMENT SYSTEM
MODEL
The implementation of the four
II. QUALITY ASSESMENT AND
conditions that must be present for
PERFORMANCE
management to succeed
IMPROVEMENT/Westgard
- mission
Multirule System
- authority
( QUALITY CONTROL&
ASSURANCE PART 2 )
- resources
III. MANAGEMENT - Accountability
ORGANIZATIONS
IV. COMMUNICATION THE IMPORTANCE OF LABORATORY
QUALITY
WEEKS
- Laboratory quality can be defined as
I. Introduction to Laboratory accuracy, reliability, and timeliness
Management of the reported test results.
II. Quality Control and Assurance

INTRODUCTION TO LABORATORY
MANAGEMENT NEGATIVE CONSEQUENCES OF
OBJECTIVES LABORATORY ERROR
- Describe laboratory management. - unnecessary treatment; treatment
complications
- List the factors that could affect - failure to provide the proper
managing the laboratory
treatment
- Describe quality management - delay in correct diagnosis
systems - additional and unnecessary
HOW CRITICAL IS THE LABORATORY? diagnostic testing.
- The laboratory plays a
central role in health care. COMPLEXITY OF LABORATORY
PROCESSES
- A method of detecting errors at each
PURPOSE OF LABORATORY
phase of testing is needed if quality
- (1) detect disease or predisposition
is to be assured.
to disease;
- (2) confirm or reject a diagnosis;
- (3) establish prognosis; PATH OF WORKFLOW
 LABMMLS LABORATORY MANAGEMENT

- entire set of operations that occur in

testing

QUALITY SYSTEMS MANAGEMENT

- coordinated activities to direct and
control an organization with regard
to quality
 LABMMLS LABORATORY MANAGEMENT
QUALITY MANAGEMENT SYSTEM
MODEL
ORGANIZATION
- The structure and management of
the laboratory must be organized so
that quality policies can be
established and implemented
PERSONNEL
- The most important laboratory
resource is a competent, motivated
staff.
EQUIPMENT
- Many kinds of equipment are used
in the laboratory, and each piece of
equipment must be functioning
properly
PURCHASING AND INVENTORY
- Proper management of purchasing
and inventory can produce cost
savings in addition to assuring
supplies and reagents are available
when needed
PROCESS CONTROL
- Process Control is comprised of
several factors that are important in
assuring the quality of the laboratory
testing processes
INFORMATION MANAGEMENT
- Information (data) needs to be
carefully managed to assure
accuracy and confidentiality, as well
as accessibility to the laboratory
staff and to the health care providers
DOCUMENTS AND RECORDS
- Documents are needed in the
laboratory to inform how to do
things, and laboratories always have
many documents. Records must be
meticulously maintained, so as to be
accurate and accessible.
OCCURRENCE MANAGEMENT
- An “occurrence” is an error or an
event that should not have
happened.
ASSESSMENT
- The process of assessment is a tool
for examining laboratory
performance and comparing it to
standards or benchmarks, or the
performance of other laboratories.
PROCESS IMPROVEMENT
- The primary goal in a quality
management system is continuous
improvement of the laboratory
processes, and this must be done in
a systematic manner
CUSTOMER SERVICE
- The laboratory should understand
who the customers are, and should
assess their needs and use
customer feedback for making
improvements.
FACILITIES AND SAFETY
 LABMMLS LABORATORY MANAGEMENT

- Security
- Containment
- Safety
- Ergonomics
 LABMMLS LABORATORY MANAGEMENT
LESSON 2 : Westgard Multirule
System ( QUALITY CONTROL &
ASSURANCE PART 2 )
DETECTING ERROR
- Errors that occur in the testing
process may be either random or
systematic.
- With random error, there will be a
variation in quality control results
that show no pattern. This type of
error generally does not reflect a
failure in some part of the testing
system, and is therefore not like to
reoccur. Random error is only a
cause for rejection of the test run if it
exceeds + 2 SD.
- Systematic error is not acceptable,
as it indicates some failure in the
system that can and should be
corrected. Examples of evidence of
systematic error include:
- * Shift - when the control is on the
same side of the mean for
fiveconsecutive runs.
- * Trend - when the control is moving
in one direction, and appears tobe
heading toward an out-of-control
value.
SHIFTS AND TRENDS
- Shifts in the mean occur when an
abrupt change is followed by six or
more consecutive QC results that
fall on one side of the mean but
typically within 95% range as if
clustered around a new mean. On
the sixth occasion this is called a
shift and results are rejected.
- Trends occur when values
gradually, but continually, move in
one direction over six or more
analytical runs. Trends may display
values across the mean, or they
may occur only on one side of the
mean. On the sixth occasion, this is
determined to be a trend and results
are rejected.
- The source of the problem must be
investigated and corrected before
patients’ samples are reported.
WESTGARD MULTIRULE SYSTEM
- In this system, 2 levels of controls
are used and a set of rules are
applied to decide when to reject a
test run.
- To use the Westgard Multirule
System, calculate the mean and
SDs for two controls and create a
Levey-Jennings chart for each
control.
- 12S rule - When only one of two
control result falls outside ±2SD but
within +3SD, it is considered a
warning rule. It is not cause for
rejecting a run, but it should alert
laboratory personnel to watch for
possible problems.
- 13S rule - If either of the two
controls falls outside the 3SD limit,
the run is “out-of-control” and should
be rejected.
- 22S rule - If one control is outside of
2SD but within 3 SD, the second
control result should be examined
carefully.
If both are outside of 2SD in the
same direction, the run should be
rejected as it is “out-of-control”.
Corrective action is required when
any “out-of-control” results are
obtained.
 LABMMLS LABORATORY MANAGEMENT

- R4S rule - This rule applies when  degradation of control

one control is greater than -2SD material;
outside the mean and another is  operator error;
outside by +2SD. The range  outdated procedure manual;
between the two is greater than  failure to follow
4SD. This indicates a systematic manufacturer’s instructions;
error and the run should be rejected.  equipment failure;
 calibration error.
- 41S rule - This rule requires control
data from previous runs. It occurs
when four consecutive QC results
for one level of control are on the
same side of the mean and more
than 1SD from the mean and, both
levels of control have consecutive
results that are on the same side of
the mean and more than 1SD from
the mean.

- 10 X rule - To apply this rule, control

data from previous runs are also
required.
- This rule applies:
 If ten consecutive QC results
for one level of control are on
one side of the mean the
mean has “shifted” and an
error has occurred.
 also if both levels of control
have five consecutive results
that are on the same side of
the mean.

SOLVING “OUT OF CONTROL”

PROBLEMS

- An investigation for the cause of the

problem must occur if controls are
rejected by the Westgard Multirule
System. First, check policies and
procedures to be sure they were
followed correctly, then consider the
following sources of error:
 reagent degradation;
 LABMMLS LABORATORY MANAGEMENT

QUALITY ASSESMENT AND strive to create constantly improving

PERFORMANCE IMPROVEMENT quality

QUALITY CONTROL (QC)

-
- application of statistical methods to MAJOR FIGURES IN
theevaluation of quality products QUALITYMANAGEMENT
and services
QUALITY ASSURANCE(QA)

- a program in which the overall

activitiesconducted by the institution
are directedtoward assuring the
quality of the productsand services
provided -
PHILIP CROSBY
TOTAL QUALITY MANAGEMENT Quality Is Free / “Zero
(TQM) defects”

- A quality management program that

includes each component in the
creation process, from the
acquisition of supplies to active
follow-up after the product or -
service has been received by a W.EDWARDS DEMING
delighted customer TQM Thinker

-
- JOSEPH JURAN
CQI, Pareto Rule
CONTINUOUS QUALITY
IMPROVEMENT (CQI/PQI )

- Process of creating an environment

in which management and workers
 LABMMLS LABORATORY MANAGEMENT

 SD, STANDARD DEVIATION -

Measurement of precision
 CV, COEFFICTION OF
VARIATION - The standard
deviation expressed as a
percentage of the mean
 CONTROL CHART - A chart
used to plot control
- measurements against standards
JAMES O. WESTGARD  RUN CHARTS - Line graphs
Westgard Rules used to display data over a
period of time

QUALITY ASSESSMENT AND SPECIALIZED LABORATORY DATA

IMPROVEMENT EVALUATION METHODS

- A quality management program that

focuses on the success of the
organization in designing and
achieving its set goals and
objectives
BASIC QUALITY CONTROL
STATISTICS -
LEVEY-JENNINGS, LJ CHART
 ACCURACY - Closeness to the
true value -
 PRECISION – reproducibility
 POPULATION - Items that are
being studied at a particular time
 SAMPLE - A part of population
that is used to analyze the
characteristics of that population
 GAUSSIAN DISTRIBUTION -
Describes the statistical
phenomenon whereby members
of population are usually evenly YOUDEN CHARTS
disbursed around the population
mean
 MEAN - The arithmetic average
 LABMMLS LABORATORY MANAGEMENT

- - PURPOSE: proficiency
testing/accreditation/ licensure
activities in the hospital programs
EXTERNAL QUALITY ASSESSMENT
PROGRAMS

NATIONAL SECTIONS
REFERENCE
LABORATORIE
S (NRL)
LUNG CENTER CLINICAL
OF THE PHIL CHEMISTRY
MULTIRULE ANALYSIS “ WESTGARD NKTI HEMATOLOGY
RULES”
RITM MICROBIOLOGY
AND
PARASITOLOGY
SACCL IMMUNOSEROLOG
Y
EAST AVENUE DRUG TESTING
MEDICAL
CENTER

INTERNAL QUALITY ASSESSMENT

PROGRAMS

- Involves running of control

materials into every run of
analysis in the laboratory before
testing the patient samples. The
results are plotted on control charts,
If the laboratory results falls outside
the range, the measurement system
must be checked and corrective
action must taken or implemented
EXTERNAL QUALITY ASSESSMENT
PROGRAMS

- Laboratory participation (voluntary

or mandatory), initiated through the
laboratory community
 LABMMLS LABORATORY MANAGEMENT
WEEK 1: Introduction to
Laboratory Management
Learning Objectives:
1. Define management.
2. Describe the management process
and functions of management
3. List factors that could affect managing
the laboratory
4. Discuss the importance of effective
laboratory management
5. Described quality management
system
- Management can be defined as
working with and through people to
accomplish a common mission.
- Generally, five conditions must be
present for management to
succeed; mission, authority,
resources, responsibility, and
accountability.
THE MANAGEMENT PROCESS
- PLANNING
 Identify goals, evaluate
current situation, establish
timeframe
 Set objectives, forecast
resource needs, implement
plan, and obtain feedback
- ORGANIZING
 Formal hierarchy
 Informal relationships
- DIRECTING
 Leadership
 Time allocation
- CONTROLLING
 Instructions, follow-up
 Modifications
THE LABORATORY
The laboratory plays a central role in
health care. The purpose of the
laboratory is toprovide physicians and
other healthcare professionals with
information to:
1. detect disease or predisposition to
disease;
2. confirm or reject a diagnosis;
3. establish prognosis;
4. guide patient management; and
5. monitor efficacy of therapy.
Laboratory quality can be defined as
accuracy, reliability, and timeliness of
the reportedtest results. An accuracy
 LABMMLS LABORATORY MANAGEMENT
level of 99% may at first glance appear
acceptable, but theresulting 1% error
can become quite large in a system
where many events occur, suchas
laboratory testing.
NEGATIVE CONSEQUENCES OF
LABORATORY ERROR
 unnecessary treatment; treatment
complications
 failure to provide the proper
treatment
 delay in correct diagnosis
 additional and unnecessary
diagnostic testing.
- In order to achieve the highest level
of accuracy and reliability, it is
essential to perform all processes
and procedures in the laboratory in
the best possible way.
- The laboratory is a complex system,
involving many steps of activity and
many people.The complexity of the
system requires that
manyprocesses and procedures be
performedproperly. Therefore, the
quality management system
model, which looks at the
entiresystem, is very important for
achieving good laboratory
performance.
QUALITY MANAGEMENT SYSTEM
- A quality management system can
be defined as “coordinated activities
to direct andcontrol an organization
with regard to quality.”
- A key LABORATORY
MANAGEMENT goal is to ensure
that quality services areprovided. To
accomplish this, every laboratory
should strive to obtain modern
equipment,to hire well-trained
staff,to ensure a well-designed
resulted in mandated programs
thatfocus on ways to identify errors
and to prevent them.
THE QUALITY MANAGEMENT
SYSTEM MODEL
- The quality model used here
organizes all of the laboratory
activities into twelve quality system
essentials.
- These quality system essentials are
a set ofcoordinated activities that
serve as buildingblocks for quality
management. Each must be
addressed if overall laboratory
qualityimprovement is to be
achieved. Assuringaccuracy and
reliability throughout the Path
ofWorkflow depends on good
management of allof the 12 quality
essentials.
 LABMMLS LABORATORY MANAGEMENT
WEEK 2.1 Quality Control and
Assurance
LEARNING OBJECTIVES
1. Describe quality control.
2. List factors that could affect quality
control
3. Discuss the importance of quality
control
4. Demonstrate quality control
procedures correctly.
Quality control (QC) monitors activities
related to the analytic phase of
laboratoryexamination. The goal of
quality control is to detect, evaluate, and
correct errors due totest system failure,
environmental conditions, or operator
performance, before patientresults are
reported.
ELEMENTS OF QUALITY CONTROL
PROGRAM
- written policies andprocedures
- training all laboratorystaff
- documentation reviewing
qualitycontrol data
IMPLEMENTATION PROCESS
The steps for implementing a quality
control program include:
1. Establish policies and procedures;
2. Assign responsibility for monitoring
and reviewing;
3. Train all staff on how to properly
follow policies and procedures; ∙
4. Select good quality control material;
5. Establish control ranges for the
selected material;
6. Develop graphs to plot control values;
these are called Levey-Jennings charts;
7. Establish a system for monitoring
control value; (Westgard Multi-rule)
8. Take immediate corrective action if
needed;
9. Maintain records of quality control
results and any corrective actions taken.
Control Materials - substances that
contain an established amount of the
substancebeing tested– the analyte.
Quality control materials are run to
quantify the variability andestablish a
normal range, and to decrease the risk
of error.
Establishing the Value Range for the
Control Material
- Once the appropriate control
materials are purchased or
prepared, the next step is
todetermine the range of acceptable
values for the control material. This
will be used andlet the laboratory
know if the test run is “in control” or
 LABMMLS LABORATORY MANAGEMENT

if the control values are not Mean, the arithmetic average of results.
readingproperly— “out-of-control” The mean is the most commonly used
- measureof central tendency used in
laboratory QC.

MEAN

Where, x – symbol for mean

x1 – xn – data point 1-n, where n is the

last result

N – number of data points

STEPS IN ESTABLISHING THE
VALUE RANGE FOR THE CONTROL
MATERIAL
Formula mean

1. Run control material repeatedly

over time.
Note: control material must be
processed in the same manner
as patient samples
2. At least 20 control data points
STANDARD DEVIATION (SD) – gives a
must be collected over a 20–30-
measure of variation
day period.
3. Once the data is collected,
calculate the mean and standard
deviation of the results.
Note: a characteristic of repeated
measurements is that there is a
degree of variation.
NORMAL DISTRIBUTION (Also known
The variability of as Gaussian distribution)
repeatedmeasurements will be
If many measurements are taken, and
distributed around a central point
the results are plotted on the graph, the
orlocation. This characteristic of
valuesform a bell-shaped curve as the
repeated measurements is known as
results vary around the mean.
central tendency
The result may show different variations
The three measures of central tendency
about the mean. To determine the
are: Mode, Median & Mean
acceptablevariation, the laboratory must
 LABMMLS LABORATORY MANAGEMENT

compute the standard deviation (SD) of Accuracy is the closeness of a

the 20 control values.
When measurements are normally
distributed, characteristic of the normal
distribution;
• 68.3% of the values will fall within -
1SD and +1SD of the mean
• 95.5% fall within -2SD and +2SD
measurement to its true value,
whereas precision(repeatability) is
the amount of variation in the
measurements.
Remember: The less variation a set
of measurements has, the more
precise it is.

• 99.7% fall between -3SD and +3SD

CALCULATING ACCEPTABLE LIMITS

FOR THE CONTROL

1. To calculate 2SDs, multiply the REMEMBER

SD by 2, then add and subtract
The purpose of qualitycontrol is to
each result fromthe mean.
monitor theaccuracy and precision
2. To calculate 3SDs, multiply the
oflaboratory assays beforereleasing
SD by 3, then add and subtract
patient results
each result fromthe mean.
COEFFICIENT OF VARIATION (CV)

- is used to monitor precision

Remember: The value of the

CVshould be less than 5%.The lower
the CV, the more precise.

Remember: If a measurement is
repeated many times, the result is a
mean that is veryclose to the true
mean.

ACCURACY & PRECISION

 LABMMLS LABORATORY MANAGEMENT
MANAGEMENT ORGANIZATION
ORGANIZATION
context of a quality management model
is used to indicate the management and
the supporting organizational structure
of the laboratory.
KEY ORGANIZATIONAL
COMPONENTS
• Leadership—Laboratory leaders must
be fully committed timplementation of
the system, and these leaders also will
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.
• 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 assuring that
timelines are met and goals achieved.
• Monitoring—As components of the
quality management system are put in
place, processes for monitoring will be
needed to assure that the system is
working, that benchmarks and
standards are being met. This element
is essential to the primary goal of a
quality system, which is continuous
improvement.
MANAGEMENT ROLE
Providing leadership
• Important roles for a leader include:
• providing vision;
• giving a direction for goal-setting;
• motivating staff; providing
encouragement
Responsibilities of managers
• establishing the policies and processes
of the quality system;
• assuring all policies, processes,
procedures, and instructions are
documented;
 LABMMLS LABORATORY MANAGEMENT

• making sure that all personnel • Organizational Authority

understand documents, instructions,
and their • is the right to give commands, take
action, make decisions to achieve
duties and responsibilities;
organizational objectives.
• providing personnel with the
appropriate authority and resources to
carry out their duties. • Line Authority

• the right to command immediate

ORGANIZATIONAL STRUCTURE subordinates in the chain of command

• An organizational structure is a system

that outlines how certain activities are
directed in order to achieve the goals of
an organization. These activities can
include rules, roles, and responsibilities.

• The organizational structure also

determines how information flows
between levels within the company.

ORGANIZATIONAL STRUCTURE

• An organizational structure is a system

that outlines how certain activities are

directed in order to achieve the goals of

an organization. These activities can

include rules, roles, and responsibilities.

• The organizational structure also

determines how information flows
between

levels within the company.

LABMMLS LABORATORY MANAGEMENT
COMMUNICATION
COMMUNICATION PROCESS
 Is the exchange of information
between at least two persons
 the act or process of receiving
and transmitting messages
ELEMENTS OF COMMUNICATION
 Sender - person wishing to
transmit a message
 Message - the actual format of
the communication effort.
 Mode of Transmission- the
vehicle by which a message is
sent.
 Receiver - the target of the
message; either an individual or
group.
 Decoding - how a receiver
translates the message
TYPES OF COMMUNICATION
 Verbal – refers to spoken words.
 Non-verbal – refers to written,
laboratory result.
BARRIERS OF COMMUNICATION
1. Structural – distance, spatial
constraints
 Action: remove or find alternative
routes
2. Semantics – words and messages,
symbolism, figures, penmanship
 Action: Pay attention to both
content and context of message
3. Technical – noise, distracting activity,
lost message, information overload.
 Action: Find alternatives routes or
times.
4. People – moods, emotions, feeling,
halo effect, perception problems,
interpersonal factors (social and
personal differences)
 Action: provide training,
groundwork, feedback,
explanations, reassurance, trust
and credibility.
5. Outcome – failure or low acceptance
of the message
 LABMMLS LABORATORY MANAGEMENT
 Action: ensure that the outcome
is within the ability of the receiver
to perform
IMPROVING THE COMMUNICATION
PROCESS
 Good Listening – asking
questions, seeking feedback
 Empathy – with concern and
interest.
 Repetition – sending message
through several different routes
 Presence of understanding –
elements of communication
 Presence of mutuality – eye
contact, sound of voice and body
language.
 Composure – ability to compose
oneself
TYPES OF LABORATORY
COMMUNICATIONS
A. Intralaboratory Communications
B. Extralaboratory Communications
A. INTRALABORATORY
COMMUNICATIONS
1. Policy Manuals
2. Procedure Manual
3. Other Internal Manuals
4. Continuing In-Service Education
- Regular continuing education
sessions for laboratory staff
 Intralaboratory Staff Meetings
B. EXTRALABORATORY
COMMUNICATIONS
1. Manual of Procedure and Collection
2. Laboratory User’s Manual
 The first section – a directory of
the laboratory sessions
(hematology, chemistry) with
listing of the key staff, the
laboratory section, telephone
numbers, operating hours and
special instructions
 The second half – an
alphabetical computer listing of
the laboratory measurements
and examinations
3. Laboratory Bulletins
 Periodic laboratory bulletins,
newsletter or measurements of
 LABMMLS LABORATORY MANAGEMENT

the month, circulated to the

medical staff, are useful means
of
 communicating information about
new laboratory services or
policies.

4. Other Extra Laboratory

Communications

 Laboratory Directors should be

available and responsive to
written or verbal communication
from the Clinician users of the
laboratory.

“NO RELATIONSHIP CAN PROSPER

WITHOUT PROPER
COMMUNICATION. AND YOU CAN’T
BE THE ONLY ONE
COMMUNICATING”