Laboratory Quality Management
Version 6.0 August 2012
This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National
Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services,
under contract No. HHSN272201200009C, entitled NIAID HIV and Other Infectious Diseases Clinical Research
Support Services (CRSS).
Objectives
2

Define the key elements of Quality Management (QM)

Describe the benefits of a Quality Management Plan
(QMP)

Describe the key elements of Quality Control (QC)

Define the statistical tools used in standard QC
calculations

Explain the importance of monitoring key quality
indicators

Explain the importance of external assessments and
internal audits

Define the elements of a Quality Improvement process
Pre-Assessment Question #1
Which of the following are key elements of Quality
Management?
A. Quality Assurance
B. Quality Control
C. Regulatory Affairs
D. A and B
E. B and C
F. All of the above
3
Pre-Assessment Question #2
Which of the following are benefits of establishing and
maintaining a Quality Management Plan?
A. Improve clinical trial outcomes
B. Increase productivity and efficiency
C. Reduce risk of medical errors
D. All of the above
4
Pre-Assessment Question #3
Which of the following are elements of Quality Control?
A. Policies
B. Performance/Documentation
C. Reviews
D. All of the above
5
Pre-Assessment Question #4
This statistic measures the central tendency of a set of
data:
A. Mean
B. Standard Deviation
C. Range
D. None of the above
6
Pre-Assessment Question #5
The following are examples of post-analytic quality
indicators:
A. Customer satisfaction
B. Specimen preparation
C. Reporting abnormal/critical test results
D. Turnaround time
E. A and C
7
Pre-Assessment Question #6
To implement an effective Proficiency Testing (PT)/
External Quality Assurance (EQA) program, laboratory
staff must:
A. Demonstrate evidence of review of the PT/EQA report
B. Implement necessary Corrective Action/Preventive
Action (CAPA)
C. Rotate PT/EQA samples among all testing personnel
D. All of the above
8
Pre-Assessment Question #7
The elements of the Quality Improvement process are:
A. Prepare, Decide, Study, Act
B. Plan, Do, Study, Act
C. Plan, Do, Study, Communicate
9
Glossary
10

Quality: The totality of features and characteristics of a
product or service that bear on its ability to satisfy stated
or implied needs

Quality Management: The overall system that includes
all activities involved in Quality Assurance (QA) and
Quality Control (QC) including the assignment of roles
and responsibilities, the reporting of results, and the
resolution of issues identified during the review
Glossary (cont’d)
11

Quality Assurance: A periodic, systematic, objective,
and comprehensive examination of the total work effort
to determine the level of compliance with accepted Good
Clinical Practice (GCP) standards

Quality Control: The real time, on-going (“day-to-day”)
observation and documentation of a site’s work
processes to ensure that accepted procedures are being
followed

Quality Improvement: Part of quality management
focused on increasing the ability to fulfill quality
requirements
Division of Acquired Immunodeficiency
Syndrome (DAIDS) Policies
Risk
Assessment
Documented
Key Points
All Aspects
of Services
12
Include EQA
and Quality
Control
Quality Management Plan (QMP)
Communicates Information About
The mission The scope of
and goals of
laboratory
the laboratory
activities
Assigning
responsibilities
Establishing
laboratory’s
commitment
to quality
Providing
framework for
the laboratory
documentation
Promotes Standardization and Consistency
13
Benefits of a QMP
Streamline laboratory processes
Enhance employee potential
Meet accreditation requirements
Reduce risk of medical errors
Improve study participant care
Increase productivity and efficiency
Reduce costs
Improve clinical trial outcomes
14
Laboratories Without QMP Experience
15
• Lack of
standardization
• Unsatisfied
customers
• Unsafe
environment (for
study participants
and staff)
• Fiscal irresponsibility
Top Issues Found During Audits
1. Assay validation
2. Approval and attestation signatures on standard
operating procedures (SOPs)
3. Parallel testing
4. Supervisor review of QC, EQA, maintenance records
5. Temperature monitoring on weekends and holidays
6. Personnel training/competency
7. Pipette calibration
8. Improper storage of reagents, QC, and calibrators
9. EQA corrective action
10. Material Safety Data Sheet (MSDS) not present in the
laboratory
16
Quality Control (QC)
QC
“…procedures for monitoring the
work processes, detecting problems, and making
corrections prior to delivery of products or services.
Statistical process control, or statistical quality control,
is the major procedure for monitoring the analytical
performance of laboratory methods. ”
17
Elements of Quality Control
Policies
Performance/Documentation
Review
Corrective action
18
QC Nomenclature
Mean: The average of a data set
_
X = ∑xi/n
19
QC Nomenclature (cont'd)
Trend
+ 2SD
+1SD
Mean
-1 SD
-2 SD
20
QC Nomenclature (cont'd)
Shift
+ 2SD
+1SD
Mean
-1 SD
-2 SD
21
QC Nomenclature (cont'd)
Standard Deviation (SD): A measure of the dispersion or
variation in a distribution
_
∑ (Xi – X)2
(n-1)
.
SD =
22
QC Nomenclature (cont'd)
Coefficient of Variation (CV): A measure of the
dispersion or variation in a distribution
23
QC Tools – Westgard Rules
+3 sd
+2 sd
+1 sd
Mean
-1 sd
-2 sd
-3 sd
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
Date
24
Quality Control Multi-Rule Flowsheet
25
What do you see?
26
Quality Indicators
Which Key Quality Indicators do you monitor
within your laboratory?
Which Key Quality Indicators should you monitor
within your laboratory?
27
Most Frequently Monitored
28

External Quality Assurance Performance

Internal Quality Control
Laboratory Operations
Pre-Analytic
Tasks
29
Analytic
Tasks
Post-Analytic
Tasks
Examples of Key Quality Indicators
Correct test(s)
ordered/
cancellations
Phlebotomy
customer
satisfaction
30
Specimen/study
participant ID
Specimen
collection/
redraw
Pre-Analytic Tasks
Accessioning
of specimen
Specimen
preparation
Transport of
specimen/
lost specimen/
missed pick-ups
Examples of Key Quality Indicators (cont'd)
Report
content
Correct
results
Analyzer
performance
31
Preparation of
specimen
Analytic Tasks
EQA results
Turnaround
time (TAT)
Quality
control
Specimen
integrity
Missed
diagnosis/
correlation to
clinical picture
Examples of Key Quality Indicators (cont'd)
Customer
satisfaction for
testing services
Release of
results
Transmission
of results/
creation of
report
Post- Analytic
Tasks
Interpretation
of results
32
Reporting
abnormal/critical
results
Reporting errors
(e.g.,
transcription)
Assessments
Assessments – External and Internal
• Assessment of quality is the means to
determine the effectiveness of the Quality
Management System
• Procedures, forms, and records
− Developing indicators to measure aspects of
the quality
− Collecting and analyzing data for quality
indicators
33
Internal Audits
Internal Audits
• An evaluative process for determining the
compliance and/or effectiveness of a process or
system
• A quality audit is a positive and constructive
process intended to identify the activities apt to
create problems
34
Resolving External Quality Assurance
Issues
35

What is the laboratory’s role?

How do you investigate/
document?

How do you evaluate results not
graded by the provider?
External Quality Assurance Activity
You have just received a report from the College of
American Pathologists (CAP) related to your laboratory’s
performance of the last general chemistry proficiency test
panel. You have received unacceptable scores on two of
the five samples.

36
What do you investigate to determine the cause of the
unacceptable results?
External Quality Assurance Activity (cont'd)
You determine that the laboratory tech who performed the
testing for the five samples inadvertently aliquoted two of
the samples into misidentified secondary containers for
testing purposes.

37
What would you do next?
Occurrence Management
Occurrence Management
• Capture and analyze information from
nonconforming events to identify systematic
problems and gain management’s commitment
to removing the cause. Linked to risk
management because it provides information on
systematic problems that could pose legal or
financial risk issues.
• Procedures, forms, and records
– Identify need for root cause analysis or other
process improvement
38
Quality Improvement (QI)
The determination of causes or sources
of problems identified by QC and QA;
for example, root cause analysis
39
Corrective/Preventative Actions
Implementation of
solutions resulting in
the reduction or
elimination of an
identified problem
40
Process Improvement
Process Improvement
• Opportunity for improvement does not always
come from problems. Many sources of
information identify needed improvements.
• Procedures, forms, and records
– Satisfaction surveys
– Occurrence management reports
– Complaints
41
Quality Improvement
42

What are we trying to accomplish?

How will we know that a change is an improvement?

What changes can we make that will result in an
improvement?
Plan, Do, Study, Act (PDSA) Cycle
PLAN
DO
Communicate
ACT
STUDY
43
Benchmarking Tools
What are
they?
44
What are
the
benefits?
How can we
use them?
Customer Service
Customer Service
• Who are your customers? What are their
needs? What have we done to meet or exceed
those needs? Are we seeking feedback?
• Procedures, forms, and records
– Instructions for receiving complaints
– Analyzing survey results
45
Satisfaction Surveys
• Why should we be concerned?
• Who should we survey?
• How do we build questions?
46
Components of a QM Plan
Can you produce data that supports the active use of
your Quality Management Plan?
47
Quality Management Case Study
Using the audit checklist as your guide, review your
handout documents. As the new Quality Management
Coordinator, you will make notes of the following:
48

Changes to be made to the forms

Improvements to be made with documentation

Any additional items you would put into place to allow
a systematic approach to Quality Management
Post-Assessment Question #1
Which of the following are key elements of Quality
Management?
A. Quality Assurance
B. Quality Control
C. Regulatory Affairs
D. A and B
E. B and C
F. All of the above
49
Post-Assessment Question #2
Which of the following are benefits of establishing and
maintaining a Quality Management Plan?
A. Improve clinical trial outcomes
B. Increase productivity and efficiency
C. Reduce risk of medical errors
D. All of the above
50
Post-Assessment Question #3
Which of the following are elements of Quality Control?
A. Policies
B. Performance/Documentation
C. Reviews
D. All of the above
51
Post-Assessment Question #4
This statistic measures the central tendency of a set of
data:
A. Mean
B. Standard Deviation
C. Range
D. None of the above
52
Post-Assessment Question #5
The following are examples of post-analytic quality
indicators:
A. Customer satisfaction
B. Specimen preparation
C. Reporting abnormal/critical test results
D. Turnaround time
E. A and C
53
Post-Assessment Question #6
To implement an effective PT/EQA program, laboratory
staff must:
A. Demonstrate evidence of review of the PT/EQA report
B. Implement necessary CAPA
C. Rotate PT/EQA samples amongst all testing personnel
D. All of the above
54
Post-Assessment Question #7
The elements of the Quality Improvement process are:
A. Prepare, Decide, Study, Act
B. Plan, Do, Study, Act
C. Plan, Do, Study, Communicate
55
Wrap Up
56