This document discusses quality management concepts in healthcare laboratories. It defines key terms like quality, quality assurance, quality control, total quality management. It explains approaches like continuous quality improvement, quality assessment and sigma metrics that are used to monitor performance and ensure reliable test results. The goal of quality management is to deliver accurate and timely reports to healthcare providers and continuously improve laboratory processes.

1.  sum-total of all the characteristics of a
product/service that has a bearing upon the
utilization of the product/service to the
entire satisfaction of the consumer
 Conformance to the requirements of users or
customers and the satisfaction of their needs
and expectations

2. 1) Acceptable
2) Accessible
3) Affordable
4) Appropriate

3.  Total Quality Management (TQM)→ an
activity to improve pt. care by having the lab
monitor, its work to detect deficiencies &
subsequently correct them.
 Continuous Quality Improvement (CQI) or
Performance Improvement (PI)→ to improve
the pt. care by placing the emphasis on not
to make mistakes in the first place
 Quality Assurance (QA)→ external activities
that ensure positive pt. outcomes. It
measures what a lab can do to improve
reliability

4.  TQM also referred to as : total quality control
(QC), total quality leadership, continuous quality
improvement, quality management science or
industrial quality management
 Quality systems in healthcare organization is
evolving
• Public & Private pressure to contain costs are
now accompanied by pressure for quality
improvement (QI)
• TQM provides – management philosophy for
organizational development & a management
process for improvement of quality in all aspects
of work

5. The Universal principles of TQM are
 Customer focus
 Management commitment
 Training
 Process capability & control
 Measurement using quality-improvement
tools

6.  Costs must be understood in the context of
quality
• Quality = conformance to requirements
• “Quality costs” =“Costs of conformance” +
“Costs of non conformance

7. Quality Costs
Costs of
Conformance
Costs of
Nonconformance
Prevention
Costs
Appraisal
Costs
External
failure Costs
Internal
failure Costs
Examples:
Training
Calibration
Maintenance
Examples:
Inspection
Quality control
Examples:
Scrap
Rework
Repeat runs
Examples:
Complaints
Service
Repeat request
Understanding of quality & cost leads to a new perspective of relationship b/n
these two concepts:
“ Improvement in quality lead to reduction in costs”
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8.  Quality improvement occurs when problems
are eliminated permanently
• Quality problems are primarily management
problems because only management has the
power to change work process
• TQM views the organization as a support
structure rather than a command structure
• Most immediate processes required for the
delivery of services are those of the frontline
employees
• Senior management’s role is to support the
frontline employees & empower them

9. 12

11.  QLPs - include analytical processes & the general
policies , practices, and procedures that define
how all aspects of the work are done
• QC- emphasizes statistical control procedures,
but also includes nonstatistical check procedures
• QA- concerned primarily with broader measures
& monitors of lab performance (turnaround
time, specimen identification, patient
identification, test utility)
• QI- a structured problem solving process to help
identify the root cause of a problem & a remedy
for that problem
• QP- provides the planning steps

13.  TQM is also considered as a quality system
that is implemented to ensure quality
• QS- “ set of key quality elements that must
be in place for an organization’s work
operations to function in a manner to meet
the organization’s stated quality objectives”

15.  The main objective of a laboratory is to
provide reliable, timely and accurate test
results. This is only possible through
- consistent monitoring and evaluation of
the laboratory’s performance ,
implementation and
- follow-up of corrective actions for non-
conformance to procedure

16. • QUALITY ASSESSMENT (EXTR.)
QUALITY: A DEGREE OF EXCELLENCE
• QUALITY CONTROL (INTER.)
+
QUALITY ASSURANCE
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17.  Internal Quality Control (IQC)
– includes personnel, instrumentation,
document control, reagent control and
corrective action
• External Quality Assurance (EQA)
– External quality control is important to
ensure the laboratory is performing to an
external standard

18.  Quality Control -QC refers to operational
techniques that must be included during
each assay run to verify that the
requirements for Quality are met with
• Quality Assurance - QA refers to all those
planned and systematic activities to provide
confidence that the results given out by the
laboratory are correct

19.  The aim of QC is simply to ensure that the
results generated by the test are correct.
However quality assurance is concerned with
much more: that the right test is carried out
on the right specimen and that the right
result and right interpretation is delivered to
the right person at the right time

20.  Quality assurance program consists of broad spectrum
of practices, plans and procedures that will assure (to
be sure and confident) that the quality will be
maintained. There are several essential elements of
quality assurance program.
- Commitment
- Facilities and resources
- Technical competence
- Technical procedures

21.  Also known as proficiency testing
 → Quality Assessment is a means to
determine the quality of the results
generated by the laboratory
 → Quality Assessment is a challenge to the
QA and QC programs
 → Quality Assessment may be external or
internal.

22.  Right recording and reporting
• Right interpretation
– Range of normal values
• Right turnaround time
• Report to right user

23.  Proper procedure includes:
– All data entry results should be verified by a
section head or supervisor (when available) and
reviewed by management for final interpretation
and release of results
– In the event that a report has already been
sent out and needs correction, a new report is
issued with updated report written on it
• The old report remains in the patient file
– Verbal result reports should be documented,
listing the time of the receipt of the report

24.  Six sigma metrics are being adopted as the
universal measure of quality for the quality
management.
 Six sigma goal for process performance shows
that error distribution of a measurment
procedure should fit within the tolerance
specification or quality requirement for that
measurment.

26.  One approach is to measure outcome by
inspection.
 Other is to measure variation and predict
process performance.

29. Sigma metrics DPMO Percent defects Percentage yield
1 691,462 69% 31%
2 308,538 31% 69%
3 66,807 6.7% 93.3%
4 6,210 0.62% 99.38%
5 233 0.023% 99.977%
6 3.4 0.00034% 99.99966%

30.  Conversion to sigma metric is done by using
standard table available. In health care
organization a defect rate of 0.033% (333
DPM) is considered excellent, where error
rates from 1% to 5% are often considered
acceptable. A 5.0% (50000 DPM) error rate
corresponds to 3.15 sigma performance and
1.0% error rate corresponds to 3.85 sigma.
Six sigma shows that the goal should be error
rate of 0.1% (4.6 sigma) to 0.01% or 100 DPM
(5.2 sigma) and ultimately 0.001% (5.8
sigma).

31.  The application of sigma metrics for
assessing analytical performance uses the
variable obtained during method validation
studies, like accuracy, precision, PPP, NPP,
sensitivity, specificity parameters and that
available from internal and external quality
control processes.

32.  In the laboratory sigma performance of the
method can be determined from imprecision: SD
or CV and inaccuracy (bias) observed for a
method and quality requirement (allowable total
error, TEa) for the test. Sigma metric from 6.0 to
3.0 represents the range from best case to worst
case respectively. Methods with sigma
performance less than 3 are not considered
acceptable for production.

33.  The practical goal is to achieve a probability
of error detection of 0.90. This is easy to
accomplish for processes with 5 or 6 sigma
performance, it requires a more careful
selection and increased qc efforts for
processes from 4-5 sigma and very difficult
for processes with less than 4 sigma.