Point of care testing (POCT) refers to testing that is performed near or at the site of a patient with the result leading to a possible change in the care of the patient. Over the past few years, the popularity and demand of POCT has been growing rapidly. This should come as no surprise as there are many advantages to POCT, for example, the added convenience of being able to obtain a rapid result at the patient’s bedside, thus allowing immediate action, saving time and improving the potential outcome for the patient.
In the continuous quality journey, Controlling laboratory Errors is an integral part & focusing on analytical, post-analytical process is the first step. Developing a reporting culture followed by thorough analysis and implementation of appropriate corrective, preventive actions is required.
A routine session on quality assurance practice in a medical laboratory to sensitize and provide basics to those interested in working in a medical testing laboratory.
How often is Right for Laboratory Quality Control?Randox
Improving Laboratory Performance Through QC - How often is right for QC? Ask the Right Questions to get the Right Answers.
It is widely accepted that laboratories should perform QC at least every day of patient testing. However, is this adequate for every assay and for every laboratory? Is running QC once per day really sufficient? what is the "right" frequency for running QC samples in your laboratory?
In the continuous quality journey, Controlling laboratory Errors is an integral part & focusing on analytical, post-analytical process is the first step. Developing a reporting culture followed by thorough analysis and implementation of appropriate corrective, preventive actions is required.
A routine session on quality assurance practice in a medical laboratory to sensitize and provide basics to those interested in working in a medical testing laboratory.
How often is Right for Laboratory Quality Control?Randox
Improving Laboratory Performance Through QC - How often is right for QC? Ask the Right Questions to get the Right Answers.
It is widely accepted that laboratories should perform QC at least every day of patient testing. However, is this adequate for every assay and for every laboratory? Is running QC once per day really sufficient? what is the "right" frequency for running QC samples in your laboratory?
Preanalytical quality control practices in clinical laboratoryDr. Rajesh Bendre
Preanalytical variables contribute maximally to lab errors. However, these variables are most difficult to control as they include human dependency for phlebotomy skills & pretest patient conditioning. Quantifying & monitoring these variables is also more challenging. Use of checklists, continuous training, competency assessments, internal audits & clinician education for appropriate test utilization form some of the tools for improving the preanalytical processes.
Acusera Third Party Quality Controls for Medical Laboratories Randox
With over 350 parameters available in our Acusera range, choice and flexibility is guaranteed. Moreover the availability of truly independent third party controls coupled with the added advantages of highly accurate target values, increased stability and unparalleled quality will optimise performance, save valuable time and minimise waste in any laboratory.
Our comprehensive range of multi-analyte controls have been uniquely developed with ease of use in mind, combining up to 100 parameters in one convenient control laboratories can significantly reduce the need for multiple, costly single analyte controls.
Consolidation
100% human controls for immunoassay purposes
Most accurate target values
Unrivalled stability
Most consistent controls
True third party controls
QUALITY
Conformance to the requirements of users or customers satisfaction of their needs and expectations.
Total Quality Management
A management approach that focuses on processes and their improvement.
Quality in clinical laboratory is a continuous journey of improving processes through team work, innovative solutions, regulatory compliance with final objective to meet the evolving needs of clinicians & patients.
Designing an appropriate QC procedure for your laboratoryRandox
Improving Laboratory Performance Through Quality Control - Five Simple Steps for QC Success.
It is easy to get caught up in an abundance of QC statistics and forget the fundamental reason why
QC exists in the first instance. QC is about detecting errors and ensuring that the results you
produce are accurate and reliable. All QC procedures should focus on reducing the risk of harm
to the patient. We are not examining statistics; we are examining real patients, real results and real
lives. Around 70% of all medical decisions are based on laboratory results, which is why it is of
utmost importance that each and every laboratory, has a well-designed QC procedure in place.
What do clinicians need to know about lab tests?Ola Elgaddar
A presentation in the Annual meeting of the Egyptian American Scholars (AEAS) in Cairo 2015.
I am trying here to describe, in short, from my point of view as a laboratorian, the points that we need to discuss with clinicians. Both groups should share some terms and definitions and should see things from the same perspective!
Slides on medical laboratory testing process and pre-analytical factors that might contribute to laboratory errors and sample rejection, and how to prevent it.
Improving Laboratory Performance Through Quality Control - The role of EQA in...Randox
Randox Quality Control's five simple steps to QC success. The second education guide from Randox QC for clinical laboratory staff. The guide will examine how EQA works, benefits of EQA and what a laboratory should look for when choosing an EQA scheme.
Preanalytical quality control practices in clinical laboratoryDr. Rajesh Bendre
Preanalytical variables contribute maximally to lab errors. However, these variables are most difficult to control as they include human dependency for phlebotomy skills & pretest patient conditioning. Quantifying & monitoring these variables is also more challenging. Use of checklists, continuous training, competency assessments, internal audits & clinician education for appropriate test utilization form some of the tools for improving the preanalytical processes.
Acusera Third Party Quality Controls for Medical Laboratories Randox
With over 350 parameters available in our Acusera range, choice and flexibility is guaranteed. Moreover the availability of truly independent third party controls coupled with the added advantages of highly accurate target values, increased stability and unparalleled quality will optimise performance, save valuable time and minimise waste in any laboratory.
Our comprehensive range of multi-analyte controls have been uniquely developed with ease of use in mind, combining up to 100 parameters in one convenient control laboratories can significantly reduce the need for multiple, costly single analyte controls.
Consolidation
100% human controls for immunoassay purposes
Most accurate target values
Unrivalled stability
Most consistent controls
True third party controls
QUALITY
Conformance to the requirements of users or customers satisfaction of their needs and expectations.
Total Quality Management
A management approach that focuses on processes and their improvement.
Quality in clinical laboratory is a continuous journey of improving processes through team work, innovative solutions, regulatory compliance with final objective to meet the evolving needs of clinicians & patients.
Designing an appropriate QC procedure for your laboratoryRandox
Improving Laboratory Performance Through Quality Control - Five Simple Steps for QC Success.
It is easy to get caught up in an abundance of QC statistics and forget the fundamental reason why
QC exists in the first instance. QC is about detecting errors and ensuring that the results you
produce are accurate and reliable. All QC procedures should focus on reducing the risk of harm
to the patient. We are not examining statistics; we are examining real patients, real results and real
lives. Around 70% of all medical decisions are based on laboratory results, which is why it is of
utmost importance that each and every laboratory, has a well-designed QC procedure in place.
What do clinicians need to know about lab tests?Ola Elgaddar
A presentation in the Annual meeting of the Egyptian American Scholars (AEAS) in Cairo 2015.
I am trying here to describe, in short, from my point of view as a laboratorian, the points that we need to discuss with clinicians. Both groups should share some terms and definitions and should see things from the same perspective!
Slides on medical laboratory testing process and pre-analytical factors that might contribute to laboratory errors and sample rejection, and how to prevent it.
Improving Laboratory Performance Through Quality Control - The role of EQA in...Randox
Randox Quality Control's five simple steps to QC success. The second education guide from Randox QC for clinical laboratory staff. The guide will examine how EQA works, benefits of EQA and what a laboratory should look for when choosing an EQA scheme.
Multi-reglas de control de calidad (CC) son diseñadas y utilizadas para minimizar falsos rechazos y mantener una alta tasa de detección de errores. Hay seis reglas principales que son utilizadas para determinar si los resultados de una serie de muestras de pacientes deben ser aceptadas o rechazadas, basadas en el rendimiento de los materiales de control contra los criterios de las reglas. Diferentes combinaciones pueden ser aplicadas en función del número de controles, al error total permisible y al instrumento en uso. El siguiente diagrama de flujo se usa a menudo para determinar si una corrida debe ser aceptada o rechazada.
Acusera 24.7 Interlaboratory Data Management Randox
Acusera 24•7 Live Online is an interlaboratory data management package designed to complement the Acusera range of Internal Quality Controls. Created to help laboratories effectively manage and interpret their QC results, the analytical capabilities of Acusera 24•7 Live Online, coupled with the superior quality and flexibility of our Acusera control range, will revolutionise your laboratory's workflow enabling early identification of any trends or system errors.
Acusera 24.7 Live Online will automatically calculate internal QC statistics including mean, standard deviation and CV. The ability to apply user defined QC multi-rules will help to reduce false rejections and maintain a high level of error detection.
Online access anytime, anywhere
Peer group data from over 20,000 participants
Peer group statistics updated daily
Unique dashboard highlights poor performance
Interactive charts combining multiple analytes, lots and instruments
Comprehensive reports including audit trail reports to aid accreditation
Automated QC result entry via Acusera 24•7 Connect
QC Multi rules - Improving Laboratory Performance Through Quality ControlRandox
Randox Quality Control's latest educational guide examines and explains what QC Multi-Rules are, How to identify an out of control event with QC rules, How to use QC Multi-Rules, The different types of analytical errors, The tools to assist labs and how a lab can troubleshoot QC errors.
QC Multi-rules are designed and used to minimise false rejections and maintain a high rate of error detection. There are six main rules used to determine if results from a run of patient samples should be accepted or rejected, based on the performance of control materials against the rule criteria. Different combinations can be applied depending on the number of controls in use, total allowable error and the instrument in use. The flow chart below is often used to determine if a run should be accepted or rejected.
Basic QC Statistics - Improving Laboratory Performance Through Quality Contro...Randox
Randox Quality Control's latest educational guide examines Internal Quality Control, External Quality Assessment, Why laboratories should run QC, How often laboratories should run QC, Basic QC statistics and the quality control process.
There are different types of QC material and each format will have it's own advantages & disadvantages. Each format will also need to be handled differently and this guide aims to explain the different methods for preparing each type of control.
Total Quality Management (TQM) by Dr Anurag YadavDr Anurag Yadav
Laboratory Total Quality Management, Concept of Laboratory errors, the quality control material, quality assurance program, factors affecting the quality of report, Steps in quality management, PDCA cycle, accuracy, precision, EQAS, IQAS, Proficiency testing.
the details are related to medical laboratory and help MBBS, MD, BSc MLT, MSc MLT, etc
How to establish QC reference ranges - Randox QC Educational GuideRandox
Establishing QC reference ranges is an important aspect of laboratory quality. Find out how to effectively set reference ranges with our educational guide.
Randox QC offer an extensive range of third party quality controls. Manufactured independently, the Acusera range delivers unbiased performance assessment with any instrument or method, helping to meet ISO 15189:2012 requirements whilst simultaneously eliminating the need for multiple instrument dedicated controls.
Acusera 24.7 is an interboratory data management software capable of automatically calculating measurement of uncertainty and six-sigma. With real time peer group updates and user friendly comprehensive charts and reports including Levey Jennings and histograms, our Acusera 24.7 software is now smarter, faster and more efficient than ever before!
Acusera 24.7 Interlaboratory Data Management - June 17 LT244Randox
Acusera 24.7 Live Online version 2.0 is here! Faster, smarter and more efficient than ever before, this interlaboratory data management program will be sure to help streamline internal QC in all laboratories regardless of size.
Acusera Verify Linearity Verification - June 17 LT674Randox
Our Acusera Linearity Sets are perfect for laboratories wishing to challenge the full reportable range of their instruments. With sets available for Roche & Beckman analysers, our sets are sure to meet all your laboratory and regulatory requirements.
RIQAS is the largest international External Quality Assessment (EQA)/ Proficiency Testing (PT) scheme, there are currently more than 45,000 participants in 133 countries.
White Paper Quality Control for Point of Care TestingRandox
Point of care testing (POCT) refers to testing that is performed near or at the site of a patient with the result leading to a possible change in the care of the patient.
The laboratory shall determine measurement uncertainty for each measurement procedure,
in the examination phases used to report measured quantity values on patients’ samples. The
laboratory shall define the performance requirements for the measurement uncertainty of each
measurement procedure and regularly review estimates of measurement uncertainty.
Troubleshooting QC Problems: Your QC has failed, what do you do next?Randox
Randox Quality Control's next 'Improving Laboratory Performance Through Quality Control' educational guide has been published with helpful tips that your laboratory can use in order to ensure it has effective troubleshooting procedures in place.
So you ran QC this morning and realised that one of your analytes has been flagged as 'out-of-control', what do you do next? Do you ignore the warning and continue patient testing, repeat the control until it's within range or do you halt patient testing and investigate the source of the error?
When it comes to troubleshooting QC errors, unfortunately there is no easy path to take. However, it's important that you have standard operating procedures in place, outlining what to do in the event of an out-of control error. Errors occur in laboratories all over the world. A lab with effective troubleshooting procedures in place will still have errors but will be able to detect them, quickly reducing their impact and reducing the risk of wasting both time and money.
How many patients does case series should have In comparison to case reports.pdfpubrica101
Pubrica’s team of researchers and writers create scientific and medical research articles, which may be important resources for authors and practitioners. Pubrica medical writers assist you in creating and revising the introduction by alerting the reader to gaps in the chosen study subject. Our professionals understand the order in which the hypothesis topic is followed by the broad subject, the issue, and the backdrop.
https://pubrica.com/academy/case-study-or-series/how-many-patients-does-case-series-should-have-in-comparison-to-case-reports/
CHAPTER 1 SEMESTER V - ROLE OF PEADIATRIC NURSE.pdfSachin Sharma
Pediatric nurses play a vital role in the health and well-being of children. Their responsibilities are wide-ranging, and their objectives can be categorized into several key areas:
1. Direct Patient Care:
Objective: Provide comprehensive and compassionate care to infants, children, and adolescents in various healthcare settings (hospitals, clinics, etc.).
This includes tasks like:
Monitoring vital signs and physical condition.
Administering medications and treatments.
Performing procedures as directed by doctors.
Assisting with daily living activities (bathing, feeding).
Providing emotional support and pain management.
2. Health Promotion and Education:
Objective: Promote healthy behaviors and educate children, families, and communities about preventive healthcare.
This includes tasks like:
Administering vaccinations.
Providing education on nutrition, hygiene, and development.
Offering breastfeeding and childbirth support.
Counseling families on safety and injury prevention.
3. Collaboration and Advocacy:
Objective: Collaborate effectively with doctors, social workers, therapists, and other healthcare professionals to ensure coordinated care for children.
Objective: Advocate for the rights and best interests of their patients, especially when children cannot speak for themselves.
This includes tasks like:
Communicating effectively with healthcare teams.
Identifying and addressing potential risks to child welfare.
Educating families about their child's condition and treatment options.
4. Professional Development and Research:
Objective: Stay up-to-date on the latest advancements in pediatric healthcare through continuing education and research.
Objective: Contribute to improving the quality of care for children by participating in research initiatives.
This includes tasks like:
Attending workshops and conferences on pediatric nursing.
Participating in clinical trials related to child health.
Implementing evidence-based practices into their daily routines.
By fulfilling these objectives, pediatric nurses play a crucial role in ensuring the optimal health and well-being of children throughout all stages of their development.
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
One of the most developed cities of India, the city of Chennai is the capital of Tamilnadu and many people from different parts of India come here to earn their bread and butter. Being a metropolitan, the city is filled with towering building and beaches but the sad part as with almost every Indian city
CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
The Promise: CRISPR offers exciting possibilities:
Gene Therapy: Correcting genetic diseases like cystic fibrosis.
Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
Off-target Effects: Unintended DNA edits can have unforeseen consequences.
Eugenics: Misusing CRISPR for designer babies raises social and ethical questions.
Equity: High costs could limit access to this potentially life-saving technology.
The Path Forward: Responsible development is crucial:
International Collaboration: Clear guidelines are needed for research and human trials.
Public Education: Open discussions ensure informed decisions about CRISPR.
Prioritize Safety and Ethics: Safety and ethical principles must be paramount.
CRISPR offers a powerful tool for a better future, but responsible development and addressing ethical concerns are essential. By prioritizing safety, fostering open dialogue, and ensuring equitable access, we can harness CRISPR's power for the benefit of all. (2998 characters)
The Importance of Community Nursing Care.pdfAD Healthcare
NDIS and Community 24/7 Nursing Care is a specific type of support that may be provided under the NDIS for individuals with complex medical needs who require ongoing nursing care in a community setting, such as their home or a supported accommodation facility.
Deep Leg Vein Thrombosis (DVT): Meaning, Causes, Symptoms, Treatment, and Mor...The Lifesciences Magazine
Deep Leg Vein Thrombosis occurs when a blood clot forms in one or more of the deep veins in the legs. These clots can impede blood flow, leading to severe complications.
Deep Leg Vein Thrombosis (DVT): Meaning, Causes, Symptoms, Treatment, and Mor...
Quality Control for Point of Care Testing - White Paper
1. QC Explained 1. 0 - Quality Control for Point of Care Testing
1
QC Explained 1.0 - Quality Control for
Point of Care Testing
Kee, Sarah., Adams, Lynsey., Whyte, Carla J., McVicker, Louise.
Background
Point of care testing (POCT) refers to
testing that is performed near or at the
site of a patient with the result leading
to a possible change in the care of the
patient. Over the past few years, the
popularity and demand of POCT has been
growing rapidly. This should come as no
surprise as there are many advantages to
POCT, for example, the added
convenience of being able to obtain a
rapid result at the patient’s bedside, thus
allowing immediate action, saving time
and improving the potential outcome for
the patient.
Although there are many benefits of using
POCT devices in terms of their
convenience, these benefits are only true if
the results produced are both accurate
and reliable. Ensuring accuracy and
reliability is the primary responsibility of
Quality Control.
Quality control is composed of two key
elements; internal quality control (IQC)
and external quality assessment (EQA). IQC
involves running quality control material
that contains analytes of known
concentration to monitor the precision of
the analytical process over time. Whereas
EQA involves running blind patient-like
samples, comparing your results to peer
results, in order to retrospectively monitor
the accuracy of reporting. EQA samples
should be treated as if they were a patient
sample and therefore must be run by
personnel who would be using the device.
This provides confidence in the reliability
of patient test results.
2. QC Explained 1. 0 - Quality Control for Point of Care Testing
2
Content
Section Title Page
1.0 Importance of Quality Control for POCT Devices 3
2.0 Who is Responsible for QC in POC Testing? 4
3.0 Choosing an Appropriate QC Procedure for your POCT Device 4
3.1 Balancing risk with the stringency of your POCT quality
control procedure
4
3.1.1 Choosing a QC procedure for High Throughput Analyser
Type POCT Instruments
5
3.1.2 Choosing a QC procedure for Cartridge Based Instruments 5
3.1.3 Choosing a QC procedure for Strip Based Instruments 6
3.1.4 Choosing a QC procedure for manually read POC Tests 7
4.0 Choosing IQC material and an EQA scheme that’s appropriate for
use with POCT devices
7
4.1 Choosing IQC material for POCT devices 7
4.2 Choosing an EQA scheme for POCT Devices 8
5.0 Additional Software Available 8
6.0 Conclusion 9
7.0 References 9
3. QC Explained 1. 0 - Quality Control for Point of Care Testing
3
1.0 Importance of Quality Control for POCT Devices
ISO 15189 states that “Quality Control
materials shall be periodically
examined with a frequency that is
based on the stability of the procedure
and the risk of harm to the patient from
an erroneous result” (1). Therefore, when
implementing a QC strategy for POCT
devices the risk of harm to the patient
should be the foundation of the plan:
where and why do errors occur and what
are the consequences of an erroneous
result to the patient? It is important to
balance the risk of harm to the patient
with the stringency of the QC procedure
applied. Inaccurate results can have
serious implications for the patient
including misdiagnosis and/or
inappropriate or incorrect medical
procedures being carried out
unnecessarily, resulting in monetary
implications for the hospital.
POCT procedures have been previously
shown to be less stable than those run
within the laboratory. For example, a study
undertaken by the Ontario Laboratory
Accreditation body found that POCT is the
largest source of error in the laboratory
when compared to other sources of error
(2) (see figure 1). This demonstrates the
definite need for a well-designed QC
procedure in a point-of-care (POC) setting
to minimise the risk associated with POCT
devices. Furthermore, another recent study
found that the most common phase for
errors in POCT was analytical, with 65.3%
of errors occurring during this phase. (3)
Conversely, in laboratory based testing the
analytical phase is the least common
source for errors (4) thus, highlighting the
importance of QC procedures for POCT
devices while also outlining how the
potential risk of harm to a patient may be
greater for POC tests compared to those
performed on laboratory based analysers.
This study also revealed that the potential
impact of quality control error on a POCT
device having a moderate adverse impact
Figure 1: Ontario
Study
4. QC Explained 1. 0 - Quality Control for Point of Care Testing
4
on patient outcome was 14.7% (3),
demonstrating that for POCT devices there
is larger room for error and a greater need
for quality control.
Some POCT device manufacturers advise
that QC procedures similar to those found
in the laboratory are unnecessary for POCT
devices. However, this is not the opinion
of the majority of laboratory professionals
who believe a place undoubtedly remains
for traditional IQC and EQA practices for
POCT. This view is supported by the
introduction of the new ISO POC specific
regulations. In 2006 a new ISO standard;
ISO 22870 was released specifically for
POCT titled: “POCT – Requirements for
quality and competence” (5). ISO 22870
advises that where available, Internal
Quality Control and participation in an
External Quality Assessment scheme is
required in the point of care setting. ISO
22870 is designed to be used in
conjunction with IS0 15189.
2.0 Who is Responsible for QC in POC Testing?
According to ISO 22870:2006 a POCT
management group should be set up with
responsibility for managing and training
staff using the equipment. This group
should be responsible for the quality
management strategy and implementation
of a staff training programme which
includes quality control, for all personnel
performing POCT and interpreting results
from a POC device.
Additionally, running of QC samples on
POC devices should be performed by
those who are using the devices regularly,
as QC samples should be run as if they
were a patient sample and therefore must
be performed by personnel who are
responsible for and undertake patient
testing.
3.0 Choosing an Appropriate QC Procedure for your
POCT Devices
3.1 Balancing risk with the stringency of
your POCT quality control procedure.
There are many risk factors that should be
considered when designing the stringency
and frequency of any POCT QC strategy.
The greater the risk, the more stringent
the QC procedure should be. When
designing an appropriate QC strategy
there are a number of risk factors that
need to be taken into consideration:
high risk tests with large impact for
the wrong result,
5. QC Explained 1. 0 - Quality Control for Point of Care Testing
5
tests used to support the clinician’s
decision in isolation,
tests acted upon immediately, and
tests performed on specimens that
are difficult to collect.
The POCT strategy will depend on the POC
device that is being used as POCT devices
can be broadly split into three categories:
1. “High Throughput Analyser”- Full size
instruments used at the point of care,
e.g.: blood gas analysers.
2. “Cartridge Based Instruments”- For
example HbA1c and INR analysers.
3. “Strip Based Instruments” e.g.:
electrochemical or reflectance strip
based glucose meters and INR
analysers.
4. “Manually read Tests” e.g.: urine
dipstick test.
3.1.1 Choosing a QC procedure for a
High Throughput Analyser Type
POCT Instruments.
A high throughput analyser mirrors those
found within the laboratory and therefore,
the quality control procedure should
mirror that seen within the laboratory.
Multi-level true third party controls should
be tested a minimum of once per day,
each day a patient sample is tested; in line
with ISO 15189 regulations. Depending on
the test in question and the number of
patient samples processed, quality control
frequency may need to be increased.
Not all IQC material can be described as
third party, as a third party control is one
which has not been designed or optimised
for use with a specific instrument or
reagent, therefore providing an unbiased,
independent assessment of analytical
performance. The accuracy and reliability
of those results should be monitored over
time to provide a true reflection of
performance.
According to ISO 22870 EQA should be
performed on all POCT devices. EQA is
useful both as an assessment of the
reliability of patient results and to help
identify internal staff training needs.
3.1.2 Choosing a QC procedure for
Cartridge Based Instruments.
For cartridge based instruments the
technology differs from that found in
standard laboratory type analysers.
However the use of third party controls is
still essential to ensure optimised
performance and accuracy.
Cartridge based devices usually consist of
two components: a cartridge based
component, and an electronic reader
based component. The cartridge based
component contains all of the necessary
“ingredients” for the analysis of the patient
sample, while the electronic reader
component is responsible for converting
the result from the cartridge component
into a numerical value for analysis.
There are many possible sources of error
with cartridge based devices: the cartridge
may have been damaged during transport,
the on-board reagents may have
deteriorated over time, the electronic
reader may become defective or the
operators of the devices may not be
adequately trained to use the device
appropriately.
6. QC Explained 1. 0 - Quality Control for Point of Care Testing
6
Each time the laboratory receives a new
batch of cartridges they should be
evaluated using multi-level, third party
controls to ensure that the cartridges have
not been damaged during transport. It is
also a good idea to periodically test
quality control samples over the shelf life
of a particular batch.
Ideally a third party control should be
used every day of patient testing to ensure
the stability of the on-board reagents and
the accuracy of the results obtained, as
recommended by ISO 15189. However, it’s
important to note that when using QC for
cartridge based devices it is only the
performance of that one cartridge being
analysed at that particular time. In
addition some cartridge based devices
have their own inbuilt QC self-check
function. Therefore, running QC daily may
not be entirely necessary however, in
doing so the laboratory is instilling
confidence that reliable patient results are
released.
On the other hand, for instruments
without a built in QC function, multi-level
third party controls should be used daily
to ensure the reliability of results. In
accordance with ISO regulations, EQA
should be performed for all cartridge
based devices.
3.1.3 Choosing a QC procedure for
Strip Based Instruments.
Finally, strip based instruments are very
similar in design to cartridge based
instrument. Like cartridges, the strips are
responsible for the analysis of the sample
however, unlike cartridge based devices
the electronic component has no QC self-
check feature and without this feature a
faulty analyser could produce erroneous
results which may remain undetected for
some time. Due to this, QC processes
should be more stringent for strip based
devices than cartridge based devices to
ensure the accuracy and reliability of the
system. Strips should be checked on
delivery using multi-level third party QC to
ensure they have not been damaged
during transit in addition to every day of
patient testing. EQA should also be
performed for strip based devices.
3.1.4 Choosing a QC procedure for
manually read POC Tests.
It is essential to use both IQC and EQA for
manually read tests, e.g.: the urine dipstick
test. There is a higher degree of human
error with manually read tests as results
can vary depending on different
interpretations and therefore there is a
greater need for quality control. Using IQC
and EQA will help to standardise results
and ensure that reliable results are
released.
7. QC Explained 1. 0 - Quality Control for Point of Care Testing
7
4.0 Choosing IQC material and an EQA scheme that’s
appropriate for use with POCT devices
As discussed above, all POCT devices
should run third party IQC samples and
perform EQA. It is important to choose
IQC material and an EQA scheme that fully
meets the needs of the laboratory.
4.1 Choosing IQC material for POCT
devices
When implementing an IQC strategy it is
important to take into consideration the
differing designs of the device and
potential risk of harm of the patient. When
choosing an appropriate QC material look
for the following features:
Ease of use – many samples are
available in a ‘liquid-ready-to-use’
format which require no preparation.
This format can be conveniently
stored at +2 to +8o
C meaning it can
be stored safely on the ward rather
than in a laboratory freezer.
A matrix similar to the patient
sample – choose samples that are as
close to a human sample as possible,
in-line with ISO15189 regulations.
Clinically relevant concentrations –
analytes should be available at
clinically significant concentrations to
accurately validate patient sample
results.
Accurately assigned - method/
instrument specific target values and
ranges should be accurately assigned.
Third party – ISO 15189 recommends
quality control material is from a third
party source.
4.2 Choosing an EQA scheme for POCT
Devices
EQA is strongly recommended for all
point of care devices. ISO 22870:2006
states, “There shall be participation in
external quality assessment schemes”.
There are many EQA schemes available
for POCT devices, it is important that you
choose a scheme that offers:
Frequent reporting to minimise the
amount of time an error can go
unnoticed.
Quality material in a format suitable
for use with POCT devices.
Well-designed reports that allow for
quick and easy troubleshooting of
erroneous results at a glance.
Multiple instrument registrations for
each EQA sample provided, helping to
save money and monitor performance
across all POC instruments.
8. QC Explained 1. 0 - Quality Control for Point of Care Testing
8
5.0 Additional Software Available
Perhaps a reason for the higher rate of
error associated with a POCT device is due
to a lack of responsibility on behalf of the
staff performing the POCT. Ultimately,
responsibility should lie within the
laboratory but how can the quality of
results released by POCT devices be
managed when the people performing the
tests are spread out in a hospital setting,
and out of direct view of the laboratory
QC Technician?
The review process can be facilitated by
QC management software, which helps the
laboratory monitor the reliability and
accuracy of results released in the POC
setting.
There are a number of QC management
programs available, however the following
requirements should be sought after:
Up to date peer group – Ideally a QC
management program should have a
peer group functionality to enable the
comparison of results to other
laboratories worldwide using the
same lot of control, method and
instrument. Peer group monitoring
should be in real time, and therefore,
should be updated daily.
Multiple instrument registrations –
the ability to register multiple
instruments is vital in POCT as there
will be a number of POCT devices
through the POC setting that will
need monitored.
Online access – within a POC setting
it’s important that results can be
entered online, anywhere at any time.
This also means that the lab manager
can remotely log onto the software to
view the QC results entered for
specific POC devices throughout the
hospital or beyond.
Multiple user levels - Different user
level accounts should be available so
that lab managers can track results.
This also ensures that each POC
operator is performing appropriate
maintenance, instrument calibration
and is adequately trained to use the
device.
User defined acceptable limits - to
be applied to QC results, so that
results can automatically be rejected
or accepted.
Indeed major sources of error have been
previously categorised to be commonly
due to operator incompetence and a
disregard for test procedures, and the use
of uncontrolled reagents and testing
equipment (6). Therefore, through using
appropriate QC management software in
the POC setting, the laboratory can reduce
the level of risk and ensure accurate
results are obtained.
9. QC Explained 1
9
6.0 Conclusion
It is important to remember that the
benefits of using POCT devices are only
true if the results obtained are accurate
and reliable however given the large
number of POCT devices available on the
market choosing an appropriate quality
control plan for your instrument can be
challenging. By following the guidelines
outlined in this paper in addition to ISO
15189 and ISO 22870:2006 you can be
assured that the management and overall
results of your POCT devices will be of a
higher and more reliable quality.
7.0 References
1. ISO 15189:201, Medical laboratories -Requirement for quality and competence.
2. Ontario laboratory accreditation programme, non-conformances identified in sites seeking
accreditation.
3. O'Kane, Maurice J., et al. "Quality error rates in point-of-care testing." Clinical chemistry
57.9 (2011): 1267-1271.
4. Kazmierczak, Steven C. "Point-of-care testing quality: some positives but also some
negatives." Clinical chemistry 57.9 (2011): 1219-1220.
5. ISO 22870:2006, Point-of-Care testing (POCT) – Requirements for quality and competence
6. Meier, Frederick A., and Bruce A. Jones. "Point-of-care testing error: sources and amplifiers,
taxonomy, prevention strategies, and detection monitors." Archives of Pathology and
Laboratory Medicine 129.10 (2005): 1262-1267.