Identification and Implementation of Quality

Indicators for Improvement, Monitoring and

Evaluation of Laboratory Quality

Prof. Hariom Sharma

Head of Biochemistry Department
Laboratory Director
Govt. Medical college & Sir T Hospital
Bhavnagar Gujarat - India

10/30/15

Objectives
Quality
Quality indicators
Definition
Identification
Implementation
Monitoring
Evaluation

Quality is never an accident;

it is always the result of high
intention,
sincere
effort,
intelligent
direction
and
skillful
execution;
it
represents the wise choice of
many alternatives.

The term Quality Indicator refers to a

systematic measurement process intended to
provide information about the quality of a
system.

Absence of evidence
is not the
evidence of absence
Always look for what is
wrong before looking
who is wrong

Quality requires planning of the processes and

procedures
that
develop
appropriate,
measurable, interpretable information upon
which action can take place in the cycle of
continuous improvement. Those procedures can
be referred to as Quality Indicators.

An active program of QUALITY management

allows the laboratory to monitor for Medical
error with the intended goals of early detection
and rapid remediation and correction, and more
importantly, prevention of errors before they
occur.

THE QUALITY TOOLBOX

Quality
Indicators
ys
e
v
r
Su

Statistics

Metrics

Lean

Six Sigma

ooxx
b
l
o
o
T
y
uuaalliitty Toolb
Thhee Q
Q
T

10/30/15

10

Indicators of Quality are Necessary

Medical errors can result in annoyance and
inconvenience such as time lost or
necessitated patient revisits, but can also
result in the more serious consequences of
diagnostic delay or error, increased cost,
inappropriate therapy, and worse, increased
risk of patient illness, debility, and sometimes
death.

Not all quality indicators are derived within

the laboratory.
Many are recommended or required over a
broader regional, state, or national network of
laboratories,
based
upon
voluntary
participation, best practice recommendation,
organizational
mandate,
or
regulatory
requirement.

QC and QLP are grouped into three areas

Pre analytical : The quality of events that occurs
before specimen arrive in the laboratory and
account for 75% of laboratory errors
Analytical : The quality of events that occurs within
the laboratory i.e., the process phase.
Post analytical : The quality of events that occur
after results leave the laboratory

Pre analytical Variables

Physician Test Knowledge
Appropriateness of Test Selection
Physician Test Ordering
Patient Preparation
Patient Identification

Specimen Labelling/ Identification

Adequacy of specimen information
Specimen Collection/Complication of phlebotomy

Sample rejection rate

Specimen Delivery Processing and Preparation

Analytical Variables
Specimen Analysis
Critical value reporting
Housekeeping record ( Incidence of sample
spillage)

Report Review or Verification

Results Review
Incidence of needle stick & other injuries
Quality control (IQC & EQAS)

Post analytical Variables

Turnaround Time
Notification of Critical Values
Report Accuracy and Completeness
Incidence of Typographical error

Report Delivery
Physician Follow-up
Interpretive Consultation
Customer Satisfaction

Other Important Indicators

Continual improvement through CME / Training /
Seminars
Equipment Down Time
Participation and Performance of EQAS
programme
Performance of IQC

Performance of Inter laboratory Comparison

Cost-related Outcomes
Reimbursement related
Laboratory Staff immunization status
Proper waste Disposal

Patient Identification

Interventions
Identify a patient
accurately or it
can certainly
contribute to
laboratory error.
(Mislabeling ???)

Patient ID protocols
Wristband verification
Delay phlebotomy until
ID corrected
Bar code, check digits,
radio ID tag

Test order Appropriatness

Interventions
Percent of laboratory
tests incorrectly
ordered or ordered
with incomplete or
inaccurate information

Computerized
ordering/prompts
Redesign of test order
forms
Order verification policy
Laboratory practice
guidelines

Specimen labeling & Identification

The specimen should be
representative, properly
collected, preserved, and
labeled.
The ideal is to get the right
sample for the right test
at the right time.

Sample collection & Transportation

Sample rejection rate

Percentage of sample rejected per month in the
laboratory.
Total no. of sample rejected in one month X 100
Total no. of sample received in that month

Criteria for sample rejection

Sample is collected in improper vaccutainer
Sample improperly labeled or unlabeled
Specimen without properly completed
request form
Specimen sample volume insufficient for
requirement of test protocol
If separated serum or plasma is grossly
hemolysed

Analytical Measurement
Instrument not calibrated properly
Specimen mix-up
Incorrect volume of specimen
Interfering substance present
Instrument precision problem

Critical Value Reporting

Percent of all critical laboratory values
reported to clinicians.
Critical laboratory values are defined as
results requiring immediate notification
to the clinician for necessary patient
evaluation or treatment.
No standard list has been developed of laboratory tests
for which critical values exist.

Interventions
Commit staff time for reporting
Automated lab reminder system
Automated phone and electronic

Incidence of Needle stick injuries

PREVENTION

RISK
Transmission of blood
born diseases through
the passage of
The Hepatitis B virus
(HBV) / (HCV) / (HIV)
etc.

Reduction or elimination
of use of sharps as much
as possible, engineering
controls (i.e., needles or
syringes with safety
devices)
Training and provision of
adequate resources, and
work practice controls

Proper disposal of needle &

Syringe

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35

Housekeeping Service of Laboratory

Cleanliness of Instrument, floor.
Temperature records
Humidity Record
Proper waste disposal

Intervention
Make check list of housekeeping service

Turn Around Time

This indicator refers to the percentage of specific
laboratory tests that do not meet a reporting
deadline.
There are no widely accepted turnaround time
(TAT) goals for specific laboratory tests.
Laboratories most commonly (41%) defined
TAT as time of test request to the time of
results reporting

Typographical Errors
Wrong name of the patient
Errors due to patient with same name and different
wards
Wrong registration no.
Wrong age / sex
Typographical error of reporting

Test reporting errors

Wrong patient identification
Report not legible
Report delayed
Transcription error

Report Delivery, Physician follow up &

patient satisfaction
There must not be any failure in
reporting/addressing the report
Critical value reporting to treating physician so
that there must not any delay in treatment or
treatment may be changed according to report
Patient satisfaction from sample collection upto
delivery of report

Best management is not clearing each task

through individuals but it is the development
of each individual through the task

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42

QUALITY CONTROL
Quality control in medical laboratory is the
statistical procedure used to monitor and evaluate
the analytical process which produces patient
result.
Statistical procedure requires:
1. Regular testing of quality control products along
with patient sample
2.Generation of QC result for evaluation

QC results are used to validate patient results.

Once validated, patient results can be used for
diagnosis, prognosis, or treatment planning.
The question of reliability for most testing can
be resolved by regular testing of quality
control materials and application of statistical
control values.

QC statistics
Mean
Standard Deviation
Standard Deviation index
Accuracy (Bias)
Coefficient of Variation

Internal Quality Control

The internal QC involves the in-house procedures
for continuous monitoring of operations and
systematic day-to-day checking of the produced
data to decide whether these are reliable enough
to be released.
The procedures primarily monitor the bias of data
with the help of control samples and the
precision by means of duplicate analyses of test
samples and/or of control samples.

Westgard Rules
The formulation of Westgard rules were based
on statistical methods.
Westgard rules are used to define specific
performance limits for a particular assay and
can be use to detect both random and
systematic errors.
There are six commonly used Westgard rules of
which three are warning rules and the other
three mandatory rules.

Westgard Rules
The violation of warning rules should trigger
a review of test procedures, reagent
performance and equipment calibration.
The violation of mandatory rules should
result in the rejection of the results obtained
with patients serum samples in that assay.

External Quality Control

External quality assessment (EQA) is the
challenge of the effectiveness of a Quality
management system.

EQA invariably refers specifically to the

challenge of quality systems in a medical
laboratory.

EQA is also known as proficiency testing.

EQA or proficiency testing is different from
quality assurance which, in a laboratory
setting, is the total process whereby the quality
of laboratory results can be guaranteed

Patient precision testing

Patient precision testing is relatively easy to
implement.
The laboratory chooses an abnormal or normal
patient sample for repeat testing on the next day
analytical run or next day.
It is a form of duplicate testing.

How often should controls be run?

Control should be assayed with each analytical run
and placed randomly through the run to detect
analytical imprecision.
Controls should also have assay values within
clinically significant ranges.
Use of multiple levels of control allows for better
laboratory decisions regarding analytical error
and validity of the run.

Take Home Message

Laboratory should select the quality indicators as per the
requirement to achieve the desired level of quality in the
laboratory.
The steps can be as follows:
Identification
Implementation
Evaluation
Outliers
Corrective action
Preventive action

THANK YOU
10/30/15

56