MODULE 11 LABORATORY MANAGEMENT

SHIFT VS. TREND – type of error that can be

found in the laboratory

SHIFT

 QC values move suddenly upward or DOWNWARD SHIFT PATTERN

downward from the mean and continue
the same way
 Mathematically changes the mean

Usually seen when:

 New reagents or quality control

material has been used
UPWARD SHIFT PATTERN
 There is an issue with the instrument:
o Chane in internal temperature,
dirty cuvettes
 Calibration was not accurate

TREND

 QC values slowly move up or down from

DOWNWARD TREND PATTERN
the mean and continue moving the
same direction over time
 Can be due to:
o Failing calibration
o Reagent stability issues

CYCLE PATTERN

CORRECTING OUT OF LIMIT CONTROL VALUES

NORMAL PATTERN 1. Determine the type of error occurring
on the basis of the rule violated
o 1 sub 3s or R sub 4s rules:
Random Error (odd numbers
o 2, 4 ,10 rules: Systemic Error
(even numbers)
UPWARD SHIFT PATTERN 2. Troubleshoot
3. Inspect the testing process
4. Correct the problem
5. Assess the need to repeat patient
testing
 6. Consult a supervisor for any decision to  Lean 6 Sigma
report patient results when a run is out
SIX SIGMA PROCESS CONTROL
of control

PROFICIENCY TESTING  If one has six standard deviations

 Used to validate a method process:
1. Sets of unknown samples are sent to
laboratories for analysis
2. Results are submitted and compared
with other laboratories using similar
methods (peer group)
 Results can provide information on the
effectiveness of quality control
protocols
STEPS IN SIX SIGMA PROCESS CONTROL
between the process mean and the
nearest specification limit
 Measures degree to which any process
deviates from its goal
 Sigma value indicates how often errors
are likely to occur:
o The higher the sigma value, the
less likely it is that the process
will produce errors

1. Define
2. Measure
3. Analyze
4. Improve
5. Control

LEAN PRODUCTION

 The quality process that is focused on

creating more value
 It involves a set of principles, practices
and methods for designing, improving
and managing processes
 Lean concepts are frequently referred to
as 5S (5 steps):
PARTICIPATING SECTIONS IN THE LABORATORY
o Seiri, Seiton, Seiso, Seiketsu,
IN EQAS
Shitzuke

WHAT IS 5S?

 Organize the workplace

 Productivity and Visual management
 Standardized working
NEW QUALITY INITIATIVES
 Makes problems immediately obvious
 Six Sigma Process Control
SEIRI – Sort, Clear, Classify
 Lean Production
SEITON – Straighten, Simplify, set in order,
Configure

SEISO – Sweep, Shine Scrub, Clean and Check

SEIKETSU – Standardize, Stabilize Conform
SHITZUKE – Sustain, self-discipline, custom and
practice
LEAN 6 SIGMA
4 Keys of Lean 6 Sigma
 Delight
 Improve
 Work
 Base
Lean Production – Focused on speed
Six Sigma Process – Focused on improving
quality
Lean Six Sigma – Focused on making work faster
and better
QUALITY MANAGEMENT
 Degree of excellence a product or
service provides
 An ongoing process that has to be
persuasive throughout the institution
TOTAL QUALITY MANAGEMENT
 Comprehensive and structured
approach to organizational
management
CHARACTERISTICS OF TQM
 Strategic and systematic approach
 Integrated system
 Process-centered
 Total employee involvement
 Continual improvement
 Fact-based decision making
 Customer-focused
TQM FRAMEWORK
 Quality Laboratory Processes –
Describes the policies, procedures,
personnel, standards, laboratory
methods, and system operating
procedures for tests
 Quality Control – procedure for
monitoring the process. Monitors
analytical (Testing Phase) performance
in relation to accuracy and precision
 Quality Assessment – Monitors the
overall performance (Addresses the pre
analytical, analytical, and post analytical
phase). Indicators of QA: Turn around
time, patient preparation, sample
receiving, feed back from doctors, and
patients can serve as External Quality
Assurance and proficiency testing
monitor analytical quality
 Quality Improvement – the outcome of
QC and QA. It helps to identify the
source of the problem
 Quality Planning
o Prerequisite to quality
assurance
o Establishes and validates
process
o Designs processes
o Select new instrumentation
o Helps in designing appropriate
QC programs
 Quality Goals
o Represent the requirement that
must be achieved
o For analytical quality: Correct
test results
BENEFITS OF TQM
 Ensures quality
 Contains cost
 Encourages active and effective
leadership
 Involves and empowers staff
 Reduce band-aid fixes
 Results in cost saving
 Reduces errors
 Ensures consistency
  Staff will have greater confidence
 All operations are transparent
 Staff will clearly understand their
responsibilities
 Improves consistency

IMPLEMENTING TQM - PDCA model for

implementation

PRE-ANALYTICAL VARIABLES

 Handling a test request

 Generally affect the composition of
body fluids before analysis
 Difficult to monitor and control
 Most occur outside the lab
 Requires the coordinated effort
 May require support from outside the
laboratory
When to use PDCA

1. As a model
2. New improvement project
3. Developing a new or improved design
4. Defining a repetitive work process
5. When planning data collection and
analysis
6. When implementing any change

PDCA Procedure

Plan – Recognize

Do – Test, Carry out

Check – Review, analyze the results

Act – Take action based on what you learned in
the study step: If the change did not work, go
through the cycle again with a different plan; if
you were successful, incorporate what you
learned from the test into wider changes
THE TOTAL TESTING PROCESS
Control of pre-analytical variables
Patient identification
 Handwritten labels and request forms
 Use of bar coding technology
 Use of wrist bands, ID folks
confirmation of identity
Test Ordering
 Second hand test ordering by nurses or
clerks exhibit higher error rates
 Direct ordering by clinicians
 Avoiding abbreviations
Specimen Collection
 Improper container, incorrect
preservatives
 Phlebotomists must undergo thorough
training to understand and follow
procedures
Specimen Transport
Delays in transport and mishandling of
specimen
 The authority to reject specimens
 Installing automated transport system
Specimen separation and distribution of
Aliquots
 Centrifuges should be calibrated and
maintained
 Collection tubes, pipettes, stoppers, and
aliquot tubes should be tested for
contamination by calcium and other
elements
Turnaround Time
 Record: Actual time of specimen
collection, receipt in the laboratory
 Reporting of test results
Patient Preparation
 Lab must provide: well written,
understandable procedures for proper
patient preparation, and specimen
acquisition. Must be made available to
all medical personnel and outpatient
Analytical Variables
Primarily depend on:
 Instruments and reagents
Must be controlled carefully
Reliable analytic methods may be obtained
through:
 Careful process of:
o Selection
o Evaluation
o Implementation
o Maintenance
o Control
Control of Analytical Variables
1. Schedule daily and monthly
maintenance
2. Routine instrument function/system
checks
3. Reagents and kits should be dated
4. New lots of reagents should be run in
parallel
POST ANALYTICAL VARIABLES
Involve:
 Report generation and delivery
 Interpretation of results
 Subsequent actions
Generally experience fewer and less severe
quality problems
Errors can be serious and significant
QUALITY CONTROL
Involves systematic monitoring of analytic
processes in order to:
1. Detect analytic errors
2. Prevent the reporting of incorrect
results
CONTROL MATERIALS
 Substance or material of determined
value
  Used to monitor accuracy or precision
of test

Ideal properties of control materials:

 Resemble appropriate human samples

 No matrix effects or stable
 Stable for prolonged periods
 Disease-free
 Known analyte concentration
 High number of users submitting data
 Convenient packaging
 Inexpensive PREPARATION OF A QC CHART

INTERNAL QUALITY CONTORL – monitor a 1. Obtain at least 20 control values

single laboratory 2. Calculate the mean and standard
deviation
 Daily monitoring 3. Calculate the confidence limit
 Precision  Usually at +- 2sd
 Accuracy 4. Plot the control values on the ordinate
EXTERNAL QUALITY ASSESSMENT – Compares (Y axis) against time on the abscissa (X
one lab against another axis)

 Maintains long term accuracy

CONTROL CHARTS

 Evaluates whether a process is

operating within expectations
 As long as the values fall within the
upper and lower limits then the process
is in control

LEVEY-JENNINGS PLOT

 Shewhart plot
 The most common intra-laboratory
quality control chart
  Commonly applied when two levels
of control are used

MULTI-RULE QC

 Uses a combination of decision criteria,

or control rules to decide whether an
analytical run is in-control or out of
control

WESTGARD RULES

CONSIDER USING WESTGARD CONTROL RUELS

 Developed by Dr. James Westgard

 Increase error detection rates
without increasing fales rejection
rates
1 2s Rule
 Uses premise that 95.5% of control
values should fall within +-2sd
  Commonly used with a Levey-Jennings R 4S Rule
chart when the control limits are set as
 1 Control measurement in a group
the mean +-2SD
exceeds the mean +-2SD and another
 Warming
exceeds the mean -2SD
 Reject

1 3S Rule

 Control limits are set as the mean +-3S

4 1S Rule
 Reject
 When 4 consecutive control
measurements exceed the mean +1SD
or the mean -1SD control limit
 Reject

2 2s Rule

 2 Consecutive control measurements

exceed the mean +- 2SD 10x Rule
 Reject
 When 10 consecutive control
measurements fall on one side of the
mean
 Reject