Professional Documents
Culture Documents
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
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:
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:
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.
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
- 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.
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
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.
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
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