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QUALITY ASSESMENT AND PERFORMANCE MANAGEMENT

QUALITY CONTROL DATA

Quality control is a set of procedures and practices that monitor the testing process and those
procedures that verify the reliability, accuracy, and precision of testing. Standards and controls are used in
this process. Standards contain a known amount of the analyte being tested and are used to calibrate the test.
Controls are materials of the same matrix as the sample (composed of serum for serum tests and composed of
urine for urine tests) that have an established acceptable range for the analyte being tested. The controls are
always run with the test, and control values are monitored statistically to assess the validity of the test results. If
the controls do not fall in acceptable range, the test results may be invalidated. By monitoring the control values
daily or with each shift, the accuracy and precision of the test method can be observed. Controls are usually in
the normal patient level and in the clinically significant abnormal level(s) (usually high and possibly also low
levels). Quality control must be recorded and analyzed to be of any benefit. Abnormal quality control results
must be noted by the technologist performing it and the supervision must be notified as well. The supervisor
and laboratory administrators also have the obligation to review the quality control records to look for both
random problems and trends or repeat problems. Most urinalysis and body fluid procedures are qualitative, but
if quantitative testing is performed, monitoring with a systematic statistical analysis such as through the use of
Westguard rules should be performed as well.

Quality control material is usually run at the beginning of each shift, after an instrument is serviced,
when reagent lots are changed, after calibration, and when patient results seem inappropriate. A quality control
scheme must be developed that minimizes reporting of erroneous results, but does not result in excessive
repetition of analytical runs. The manufacturer should recommend in their product labeling the period of time
within which the accuracy and precision of the instruments and reagents are expected to be stable. Each
laboratory should use this information to determine their analytical run length, taking into consideration sample
stability, reporting intervals of patient results, cost of reanalysis, work flow patterns, and operator
characteristics. The user's defined run length should not exceed 24 hours or the manufacturer's recommended
run length. Quality control samples must be analyzed at least once during each analytical run. Manufacturers
should recommend the nature of quality control specimens and their placement within the run. Random
placement of quality control samples yields a more valid estimate of analytical imprecision of patient data than
fixed placement and is preferable.

Quality control materials should have the following characteristics. They should have the same matrix as
patient specimens, including viscosity, turbidity, composition, and color. For example, a method that assays
serum samples should be controlled with human serum-based controls. Quality control material should be
simple to use because complicated reconstitution procedures increase the chance of error. Liquid controls are
more convenient than lyophilized controls because they do not have to be reconstituted. Controls should have
minimal vial to vial variability, because variability could be misinterpreted as systematic error in the method or
instrument. Quality control materials should be stable for long periods of time. Controls with short shelf lives
necessitate frequent reordering and verification against the outgoing material, creating more unnecessary work.
Quality control material should be available in large enough quantities to last at least one year. Purchasing a
large batch decreases the number of times that control ranges have to be established.

Controls should have target values that are close to medical decision points. Quantitative tests should
include a minimum of one control with a target value in the healthy person reference interval and a second
control with a target value that would be seen in a sick patient. Examples include sodium controls of 140 and
115 me/L and glucose controls of 75 and 225 mg/dL. If three control levels are run, an abnormally low patient
range should be included. Quality control levels for therapeutic drug monitoring should mirror therapeutic,
toxic, and trough values. If a test is qualitative, giving either negative or positive results, a negative control and
a weak positive control with a concentration at the lowest detectable level are recommended. Semi-quantitative
tests should have controls at each grade level - trace, 1+, 2+, etc.

Both assayed and unassuaged control material are available. Assayed controls are measured by a
reference method and sold with published target values. They are more expensive than unassuaged controls and
are not cost effective for routine quality control in a hospital or reference laboratory. Assayed controls are
recommended for physician office laboratories. Unassayed controls must be analyzed by the laboratory to
determine the target value and acceptable range. Comparison studies need to be run between the current and
new unassayed control materials. If the new control material is from the same manufacturer, only five samples
of the new control material need to be run to establish a mean. If the mean is close to the mean of the outgoing
quality control material, the new control material can be accepted. No data points should be excluded unless
they are known to be result of operational errors. The standard deviation of the outgoing controls is adopted for
use until enough data points are collected for calculation.

Interpretation of quality control data involves both graphical and statistical methods. Quality control data is
most easily visualized using a Levey-Jennings control chart. The dates of analyses are plotted along the X-axis
and control values are plotted on the Y-axis.The mean and one, two,and three standard deviation limits are also
marked on the Y-axis.Inspecting the pattern of plotted points provides a simple way to detect increased random
error and shifts or trends in calibration.With a correctly operating system, repeat testing of the same control
sample should produce a Gaussian distribution.That is, approximately 66% of values should fall between the +/-
1 s ranges and be evenly distributed on either side of mean.Ninety five percent of values should lie between the
+/- 2 s ranges and 99% between the +/- 3 s limits.This means that 1 data point in 20 should fall between either
of the 2 s and 3 s limits and 1 data point in 100 will fall outside the 3 s limits in a correctly operating system.In
general, the +/- 2 s limits are considered to be warning limits.Values falling between 2 s and 3 s indicates the
analysis should be repeated.The +/-3 s limits are rejection limits.When a value falls outside of these limits the
analysis should stop,patient results held, and the test system investigated.

QUALITY ASSESSMENT TOOLS AND APPLICATION

Quality assessment

Quality assessment (QA) is the evaluation of the results obtained in the lab using known standards and
proficiency panels in order to validate quality control and quality assurance programs. Quality assessment can
be internal, where the lab’s staff performs the verification tests, or external quality assessment (EQA), where an
agency outside the lab is tasked with examining the lab’s performance. It also lays the foundation for
recognition of the lab’s conformance by external groups.

Quality assessment in the lab should be regular to adequately monitor the effectiveness of the laboratory
quality management system. Two types of assessments or audits are available that can yield useful information
to improve processes and procedures in the lab:

 Internal quality assessment


 External quality assessment
Internal quality assessment
An internal quality assessment (IQA) can act as a preparatory event for an external quality audit. It can be used
to quickly identify any non-conformance and give the lab the opportunity to rectify it before the more impactful
EQA. It can be performed as frequently as needed especially when a problem is identified within the lab
workflow.
For a successful internal quality assessment, the lab quality manager should:

 Ensure there is a formal plan on the IQA test. This should include various checklists and recommended
guidelines and standards.
 Identify the personnel to carry out the assessment. It is important to appoint staff from different areas to
assess workflows that they are not routinely involved in. In addition, the appointed auditors must have
the technical skills needed to evaluate such an area and have a good grasp of the lab’s quality
management system.
 Consolidate information from internal auditors and prepare a report on the findings.
 Share/present the findings with the laboratory management and the staff.
 File the findings as part of the permanent lab recovery method to be used to monitor the process of
improvement in conformance.

Application:
Internal quality control consists of internal monitoring systems built in to the test system and may be called
electronic, internal, or procedural controls. Internal or procedural controls monitor the correct addition of a
patient specimen or reagent, the instruments/reagents interaction, and test completion. Electronic controls
monitor a test system’s electronic or electric components.
External quality assessment
This involves a comparison of the lab’s testing and analysis performance to another similar lab or reference
lab.A laboratory can undergo an EQA for a variety of reasons including the following:

 Because it is a mandatory legal requirement by local or national authorities.


 As part of the process of accreditation, certification, or licensure.
 Some funding organizations may require such validation of performance in order to consider the lab
qualified to receive their funds.
Application:
External quality controls are used to verify the accuracy (ability to obtain the expected result) and precision
(ability to obtain the same result on the same specimen) of a test and are exposed to the same conditions as the
patient samples. Reliability is the ability to maintain both precision and accuracy. Commercial controls are
available for the urine chemistry tests, specific gravity, and for certain microscopic constituents. Analysis of
two levels of control material is required. Documentation of QC includes dating and initialing the material when
it is first opened and recording the manufacturer’s lot number and the expiration date each time a control is run
and the test result is obtained.
The EQA process can be carried out through proficiency testing, retesting of samples already analyzed in the
lab undergoing auditing, and on-site evaluation.
Proficiency testing
This is the most widely used EQA tool that tests a lab’s performance and the competence of its personnel. It
involves challenge tests where the agency/lab proving the proficiency test sends an unidentified sample or test
material to the lab undergoing auditing. The lab is supposed to use the routine tests and workflow procedures
i.e. treat the test sample as any other sample sent into the lab. This is to ensure the results correctly reflect the
labs’ abilities.
Once the test is complete, the results are sent to the proficiency test provider which communicates the score of
the challenge. This score is used to gauge the effectiveness of the lab’s quality management system.
Re-testing
This involves the independent re-examination of tests. It is appropriate only for certain labs and tests such as
hematology and pathology tests where the preserved samples can be tested against the reference. The process is
blinded, whereby the evaluators do not know the reported results from the lab being audited.
On-site assessment
This gives a real-time assessment of procedures and staff competence. It involves periodic visits to the lab by
evaluators.
Documentation

The IQA and EQA produce an audit report that contains:

 Identification of areas within the laboratory workflow, where quality standards are not being met.
 Preventative and corrective actions to be taken to address non-conformance issues.
 Any training needs for the staff.
QUALITY MANAGEMENT CONTROL DESIGN

Quality management (QM) refers to the overall process used to ensure that laboratory results meet the
requirements for health care services to patients. Laboratories are required to develop procedures to monitor and
ensure quality in all aspects of laboratory services. A QM program is an accreditation requirement, and good
documentation of the metrics, the review process, and the improvements made is necessary.

Statistical quality control and proficiency testing, are two important components of a QM program that
address measurement procedures. Metrics related to QC activities may be evaluated as part of monitoring the
performance of a measurement system. The following may be useful indicators of method performance issues:

 Frequency of QC alerts
 Frequency of recalibration based on QC alerts
 Number of reagent changes due to QC alerts
 Number of times controls were repeated because of QC alerts
 Frequency of unscheduled maintenance due to QC alerts
Directly related to the quality of test results are pre-analytic components such as patient preparation; sample
collection, transportation, storage, and preparation for testing; and post analytic components such as result
reporting, critical value notification, and provision of interpretive information. In some cases, the quality
requirements extend outside the laboratory and require cooperation with health care partners who order
laboratory tests and act on the results. A QM program defines data-based metrics or indicators that are
monitored at regular recurring intervals to provide information on the adequacy of all influences on laboratory
quality.

Total Quality Management (TQM)is based on a team concept involving personnel at all levels working
together to achieve a final outcome of customer satisfaction through implementation of policies and procedures
identified by the CQI program. This concept applies scientific principles to management and uses graphical and
statistical analysis of data as a basis for decision making.10 TQM is a systematic problem-solving approach
using visual tools to identify the steps in the process for meeting customer satisfaction of quality care in a
timely manner at reduced costs. In the health-care setting, the patient is the ultimate customer; customers also
include health-care providers, personnel in other departments, and the patient’s family and friends. TQM is far-
reaching and encompasses the quality and performance assessment of the infrastructure (physical, personnel,
and management), processes, outcomes, and customer satisfaction.

A QM program defines data-based metrics or indicators that are monitored at regular recurring intervals to
provide information on the adequacy of all influences on laboratory quality. A QM committee oversees the
development of metrics and their regular review, and initiates quality improvement actions in response to
metrics that indicate a need for improved performance in a particular aspect of laboratory management. A QM
committee is typically chaired by a laboratory director or section director and includes senior level
representation from all service areas, including the laboratory information system. Monthly meetings are
typical. The data collected are frequently from the previous month, so the review is retrospective. However,
automation of data management can make some metrics available close to real time for more immediate
monitoring and intervention. For example, turnaround time from specimen receipt to result reporting can be
monitored continuously with a scrolling computer display report to assist medical technologists in tracking stat
requests.

In addition to the metrics, thresholds for acceptable values need to be defined for each metric. Metrics that
exceed thresholds require analysis, and a plan is developed for corrective action. Thresholds are established on
the basis of what is considered good laboratory practice and may be different in different situations. It is not
possible to have zero mistakes in laboratory service; consequently, thresholds need to be realistic and can be
changed as quality improvement programs are applied. The total number of observations examined by a metric
should be recorded, along with the data for a given reporting interval.

It is recommended that the metrics are reported to allow trends to be identified, for example, by showing
data for 6 or more months on a page. Graphical presentation is very effective to monitor trends and can easily
include 1 or more years on a single graph. Many metrics are useful to track indefinitely to document that
laboratory service continues to meet performance expectations, and to have an alert mechanism when a change
in the environment has adversely affected laboratory service.
Role in quality management system

 Assessment is a critical aspect of laboratory quality management and ways. One of the
commonly employed assessment methods is that of external quality system.

EQA (External Quality Assessment)

 This term is used to describe a method that allows for comparison of a laboratory’s testing to a
source outside the laboratory. This comparison can be made to the performance of the peer
group of laboratories or to the performance of a reference laboratory.

Types of EQA

1. Proficiency – external provider sends unknown samples for testing toa set of
laboratories, and the results of the laboratories, and all the results of laboratories are
analyzed, compared and reported to the laboratories.
2. Rechecking or retesting- slides that have been read are rechecked by reference
laboratories, samples that have been analyzed are tested allowing for inter laboratory
testing.
3. On-site evaluation- usually done when it is difficult to conduct traditional proficiency
testing or to use the rechecking/retesting method.

EQA benefits

1. Allows comparison of performance and results among different sites


2. Provides early warning for systemic problems associated with kits or operations
3. Provides objective evidence of testing quality
4. Indicates areas that need improvement
5. Identifies training needs

Principal characteristics of an EQA scheme

 For the improvement of the laboratory quality management system , as it is a measure of


laboratory performance
 EQ A programs can either be free of charge or require a fee. Free EQA program include those
offered by a manufacturer to ensure equipment is working correctly, and those organized by a
regional or national program for quality improvement.
 Some EQA programs are obligatory , either required by an accrediting body or law . Others are
voluntary, and the quality manager may choose to voluntarily participate in an EQA program in
order to achieve improvement in the quality of the laboratory’s performance.
 The EQA program can be organized at different levels: regional, national or international
 Indivdual laboratory results are kept confidential, and generally are only known by the
participating laboratory and the EQA provider
 Some EQA may address a single disease: for example, the EQA program for tuberculosis. Others
may address many kinds of laboratory tests, looking at the overall testing performance for
microbiology.
QUALITY SYSTEMS MANAGEMENT

- ensure that quality laboratory services are provided. To accomplish this, every laboratory
should strive to obtain
modern equipment, to hire well-trained staff, to ensure a well-designed and safe physical
environment, and to create a good management team.

Errors in the laboratory

 Preanalytic errors included hemolyzed, clotted, or insufficient samples; incorrectly identified or


unlabeled samples; and wrong collection tube drawn and improper specimen storage
 Analytic errors includes calibration error and instrument malfunction
 Postanalytic errors included reports sent to the wrong physician, long turnaround time, and
missing reports

A. TQM (Total Quality Management) and CQI ( Continuous Quality Assessment)

-standard approaches to quality leadership and management

TQM- systems approach that focuses on teams, processes, statistics, and delivery of services/products
that meet or exceed customer expectations

- TQM thinking strives to continually look for ways to reduce errors by empowering employees to assist
in solving problems and getting them to understand their integral role within the greater system

CQI- is an element of TQM that strives to continually improve practices and not just meet established
quality standards

Quality Management: Traditional Versus TQM Thinking

Traditional thinking TQM thinking


Acceptable quality Error-free quality
Department focused Organization focused
Quality as expense Quality as means to lower costs
Defects by workers Defects by system
Management-controlled worker Empowered worker
Status quo Continuous quality improvement
Manage by intuition Manage by fact
Intangible quality Quality defined
We versus they relationship Us relationship
End-process focus System process
Reactive systems Proactive systems
B. Six Sigma- a process improvement program that is a hands-on process with the single mantra of
“improvement”: improved performance, improved quality, improved bottom line, improved customer
satisfaction, and improved employee satisfaction

Six Sigma Steps

1. Define project goal or other deliverable that is critical to quality.


Ex. Emergency department results in less than 30 minutes from order

2. Measure baseline performance and related variables.


Ex. Baseline performance: 50% of time results are within 30 minutes, 70% within 1 hour, 80%
within 2 hours, etc. Variables: Staffing on each shift, order-to-laboratory receipt time, receipt-to-
result time, etc.

3. Analyze data using statistics and graphs to identify and quantify root cause.
Ex. Order-to-receipt time is highly variable because samples are not placed in sample transport
system immediately and samples delivered to laboratory are not clearly flagged as emergency.

4. Improve performance by developing and implementing a solution.


Ex. Samples from emergency department are uniquely colored to make them easier to spot among
routine samples.

5. Control factors related to the improvement, verify impact, validate benefits, and monitor over
time.
Ex. New performance: Results available 90% of time within 30 minutes

Through this process, the number of defects per million opportunities (DPMO) is measured. A defect is
anything that does not meet customer requirements

C. Lean process- was ultimately designed to reduce waste. The intent of Lean is to reduce costs by
identifying daily work activities that do not directly add to the delivery of laboratory services in the most
efficient or cost-effective ways

- utilizes fewer resources, reduces costs, enhances productivity, promotes staff morale, and
improves the quality of patient care. Lean directly addresses the age-old concept of “that’s the way we
always did it” and looks for ways to improve the process

Ex: relocating analytic equipment to an area that would require fewer steps, thus improving turnaround
time; consolidating test menus to fewer instruments, eliminating the expense of maintaining multiple
instruments and supplies; placing pipettes, culture plates, etc., in easy to access areas; and reallocating
staff to maximize use and minimize wasteful downtime
Quality Control

 Also called statistical process control. It is a process to periodically examine a measurement


procedure to verify that it isperforming according to pre-established specifications

OVERVIEW OF QUALITY CONTROL


PROCEDURES
Statistical QC evaluates the measurement procedure by periodically assaying QC materials for which
the correct result is known in advance. If the result for a QC material is within acceptable limits of
the known value, the measurement procedure is verified to be performing as expected, and results
for patient samples can be reported with good probability that they are suitable for clinical use. If
QC results are not within acceptable limits, patient results are not reported and corrective action is
necessary. Good practice requires verification that a method is performing correctly at the time
patient results are measured.

Levey-Jenning - also called Shewhart plot, which is the most common presentation for evaluating QC
results. This format shows each QC result sequentially over time and allows a quick visual
assessment of method performance, including trend detection
±1 SD = 68.3% of observations
±2 SD = 95.4% of observations
±3 SD = 99.7% of observations

Mean - represents the target or expected value for the result,

SD - represent the expected imprecision for the method

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