Mid 1 LO1 -LO3. 7 Flashcards
Why do we need to take QC 194?
3
quality control, management, assurance
laboratory quality 3 key words
accuracy, reliability and timeliness
Quality is defined as
excellence
What is Quality Assurance?
all the actions a laboratory takes to ensure quality results
laboratory errors cost in 3 things
time
personnel effort
poor patient outcomes
inaccurate results provided lead to these consequences
- Unnecessary treatment
- treatment complications
- failure to provide the proper treatment
- delay in correct diagnosis
- additional and unnecessary diagnostic
testing
achieving 99% level of quality =
accepting a 1% error rate
In order to achieve the highest level of accuracy & reliability it is essential to
perform all processes and procedures in the
laboratory in the best possible way
A Quality Management System for the Laboratory
is what type of method
A method of detecting errors at each phase of testing is needed if quality is to be assured
ISO standards dos what
groups the laboratory system into 3 categories
laboratory systems the 3 categories by the ISO
also called The quality assurance cycle
Preexamination, Examination, Postexamination
= Pre-Analytic, Analytic, and Post-Analytic processes
Quality system essentials : The building blocks/ 12 QSEs= how we achieve excellent performance
what are the 3 sub categories
The lab
The work
Performance
Quality system essentials : The building blocks/ 12 QCs
The lab : 6 subs
-Organization
-customer focus
-facilities and safety
-personnel
-purchasing and inventory
-equipment
Quality system essentials : The building blocks/ 12 QCs
The work: 3 subs
-Process management
-Documents and records
-information management
Quality system essentials : The building blocks/ 12 QCs
performance: 3 sub
-nonconformance managements
-assessments
-continual improvement
Quality system essentials : The building blocks/ 12 QCs
performance: 3 sub
-nonconformance managements
-assessments
-continual improvement
Quality Management System
what does it do
international vs Canada
= Coordinated activities to direct and control an organization with regard to quality (ISO-international, CLSI-Canada)
Path of Workflow: 5
The patient
test selection
sample collection
sample transport
repost creation
what is the path of workflow accessing ? important in
validity
QSEs
1. Organization
-must be structured
-Responsibilities, authorities
-provision of recourses
-communication
ex
following governing bodies for Structure
Quality planning - reports, improvement process
Communication -huddles, documents, reports
QSEs
2. Customer service
clinicians, patients
-customer feedback documented and analyzed
-informing costumers of changes
-costumers can email concerns
-safety alert system that both can report to
QSEs
3. Facilities and Safety
-safe working environment
-transport management
-security
-containment
-waste management
-laboratory safety
-ergonomics
ex
having safety committees and governing bodies
-biohazard safety/ disposal
-having codes in emergencies/ colors
-chemical hygiene
which ISO safety standards number regulates safety regulations
15190
number too make a safety issue report
306 655 1600
QSEs
4. Personnel
- Human resources
- Job qualifications
- Job descriptions
- Orientation
- Training
- Competency assessment
- Professional development
- Continuing education
- SOPs (standard operating procedures)
- Work logs
- confidentiality
what does HIPA stand for
Health Information Protection Act
QSEs
5. Purchasing and Inventory
- Vendor qualifications
- Supplies and reagents
- Critical services
- Contract services
- Contract review
- Inventory management
-documentation - proper returns in case of defects
QSEs
- Equipment
- Acquisition
- Installation
- Validation
- Maintenance- scheduled and loged
- Calibration
- Troubleshooting
- Service and repair
- Documentation/records
- Procedures
- Running controls
-operation life cycles
-justifying needs for equipment
-decommissioning
QSEs
- Process control
- Quality control
- Sample management
- Method validation
- Method verification
pre-analytic, analytic, post analytic
The phases include patient preparation and proper identification, sample collection
requirements, control samples, calibrators, reagents and equipment performance, correlation of
test results and proper entry of patient results into the computer system for the physicians.
how long is the turn around time
1 hr
QSEs
8. Documentation and Record Keeping
Laboratory information is permanent and cannot be tampered with unless signed or
initialed, therefore, record keeping is a legal responsibility under government
regulations and should be confidential, yet easily retrieved for use by the
accreditation team. As well, log books are kept for maintenance, temperatures of
fridges, water baths, incubators etc. for specific periods of time, determined by
accreditation and federal regulations.
-Collection
-review
-storage
-retentions
QSEs
- Information Management
what important groups is under here
laboratory information systems LIS incorporates all the processes necessary to manage incoming and outgoing patient information using unique identifies (patient and samples) and limits who can access the confidential information which is protected by law
- Confidentiality
- Requisitions
- Logs and records
- Reports
- LIS
-against loss of data
-testing info
-sharing documents not using email
-secure and monitored access
-planning for information needs
-integrity of data transfers or transmission
-information availability during downtown
-analysis, design, and documentation of lab processes
-verification and validation of lab processes
-quality control of lab process
-managing and controlling changes in lab processes
QSEs
Performance block
Nonconformance management
10. Occurrence management
-An error or event that should not have happened
-complains
-mistakes and problems
-root cause analysis
-immediate actions
-corrective actions
-preventative actions
example of dealing: recognize, report, initiating, documenting
call in safety issues
,management notification of reports
QSEs
- Assemnents
Laboratory assessment = a tool for examining laboratory performance and comparing it to standards or benchmarks of the performance of other laboratories.
May be internal or external
ISO (Internal Standards Organization) – requires accredited laboratory auditors to compare results from similar laboratories to assess laboratory
performance.
Audits may be internal or external
mainly accreditation inspections related
proficiency testing for test accuracy
QSEs
Continual improvement
12. Process improvement
-The deming cycle
-PDCA cycle : Plan, Do, Check, Act
-prioritization
-impact vs effort assements
-protective and corrective actions
-problem resolutions
Lab 1st identifies issues then gathers the info…a
plan is made for improvement…plan
implemented…data gathered and assessed…plan is
updated..corrective action is taken to ensure plan
effective ..then process begins cycle again
who are labs audited by
ISO (Internal Standards Organization)
who conducts the accreditations inspections
the college of physicians and surgeons CPSS
you get a certificate of accreditation
every 305 CPSS and every 2 years ASHI
T/F QSES does not gurantee and error free lab
T
T/F ISO and CLSI are compatible
T
ISO 9001:2015
Quality Management System- Requirements
ISO/IEC 17025:2017
General requirements for the competence of testing and calibration laboratories
ISO 15189:2012
Quality management in the clinical laboratory
QMS01
A Quality Management System Model for Laboratory
Services
This guideline provides a model for medical laboratories to
organize the implementation and maintenance of an effective
quality management system
Quality
in Learning Step 1 was defined as “degree of excellence”. It can now be
expanded and clarified to “providing consistent services which meet or exceed
the needs of the customers (patients)’’
A benchmark
serves as the standard of excellence or performance level against which a
process, in this case laboratory service, is measured. If the service does not
meet a certain benchmark, then the quality must be improved
Continuous Quality Improvement Program (CQI)
is the activity associated with improving
the laboratory’s ability to constantly improve the quality of the lab processes.
Quality Management Systems (QMS)
) can be defined as the “achievement of quality as a
continuous process involving all personnel at all levels of an organization in
the pursuit of excellence in every process, with the ultimate objective being
quality patient care”. To facilitate QMS, all employees must be empowered
and tools to assist in measuring variation in lab results (preventative &
corrective) tools to evaluate statistics and to continuously find ways to improve
procedures and comply with accreditation expectations.
Empowerment
means providing staff with opportunities, the authority and resources to settle
quality issues in which they are directly involved.
Accreditation
is a non-governmental, external, peer review process for assessment of
healthcare facilities, laboratories or educational programs against a certain
benchmark. It provides a professional judgement about the quality of the
facility and encourages continued improvement. It also provides a good
indication to the public that each accredited facility is capable of functioning at
the required level of competence.
ISO 15189
Accreditation
Standards must be met for an organization to be accreditedà
Accreditation Canada (AC) Diagnostics accreditation program
assess the ability of a facility to perform diagnostic testing with
formal recognition of this competence through accreditation to
the ISO 15189 Plus requirements.
Laboratory Quality Assurance Program
(LQAP) administrated by whom
College of Physicians and Surgeons of
Saskatchewan
- The Laboratory Quality Assurance Program (LQAP) is responsible for establishing the requirements and standards of medical laboratories in the province of Saskatchewan and to ensure their compliance with the Medical Laboratory Licensing Act and Regulations
- The LQAP consists of two types of committees comprised of medical and technical experts in the relevant discipline
Internal Quality Assurance Procedures
- Internal quality assurance à focused around testing of patient clinical samples
- Monitoring is by the facility or department so then internal
review pre -post analytical images that have many ex
External Quality Assurance Programs
- EQA is used to evaluate laboratory testing accuracy
- EQA tools are shipped from the provider directly to the laboratories
on a rotational basis. Testing is performed in the same manner as
a patient specimen. - LQAP mandates that EQA assessments be performed for all tests
- EQA providers for Saskatchewan are:
* The College of American Pathologists (CAP)
* One World Accuracy
* Clinical Microbiology Proficiency Testing (CMPT)- American Proficiency Institute (API)
Quality Assurance Audit
- Provides the lab with knowledge of how well it follows its own quality control program
- By conducting its own internal quality audit assures that the lab is providing reliable results. It assesses the validity of the results.
- It is achieved by reviewing daily QC data in the lab as well as cumulative reports over a time frame
Continuous quality
improvement
- PDSA cycle
- Continually asking questions
every step of every process in
the laboratory to see if there
are ways to improve eg) speed
up processes/improve - Huddle/meeting discussions,
safety alert system reviews,
audit reviews, staff suggestions
CLSI vs ISO
Non-profit organization that brings together the varied perspectives and expertise of the worldwide laboratory community for the advancement of a
common cause
-developed the quality management system
model used in training for QMS and is fully compatible with ISO
vs
* An international standard dedicated to Quality Management Systems (QMS)
-established standards for industrial manufacturing
problem solving process the MC in test
IOS MED
1 Input: A phlebotomist complains that inpatients are never properly identified.
2 Occurrence Indicator: The phlebotomist finds an inpatient without a wristband.
3 Standard: All inpatients must have wristbands when they are admitted to hospital. No procedure will be performed on a patient unless they have a
wristband.
4 Monitor : Effective immediately, the number of patients without wristbands will be
counted for the next 30 days by the phlebotomy team.
5 Evaluate : The lab supervisor will evaluate the data and give her recommendations to the nursing supervisor.
6 Document: The lab supervisor will document the entire process including the results
from monitoring, recommendations for further action, and the results of
any corrective action that was taken.
Occurrence or Non-Conforming Event
Evaluation should include:
problem description, action plan, monitoring, summary of results and recommendations, correct the problem.
RRID
Recognizing
* Recognize when a reportable even occurs
* Reporting
* Report the even to appropriate person
* Initiating
* Initiate corrective action
* Documenting
* All events and their corrective action must be documented
LO2 begins
Pre-Analytical Variables
what minimizes them
- Factors that can affect patient’s test results before the specimen is tested in the lab.
- QA minimizes this risk before testing
Policy Manuals
- Outline administrative and operational issues
- Ensures effective communication
- Everything must be documented
- Ensures a standard of quality in the work
- Policy manuals are a useful tool for how the lab should be
organized and complete
Laboratory Logs
LIS
- Internal manuals or computerized records of patient specimens arriving at a specific department
- LIS = Laboratory Information Systems
Procedure manuals
SOPs (standard operating procedures) step by step
instructions on how to perform something
TAT or Turn around time
- = time sample collected to when result released
- This is also monitored/data assessed and helps identify problems, corrections and can affect patient treatment
What are the two most important steps
before collecting a patient specimen?
- Patient Identification
- Patient Preparation
Calibrators are
solutions with an exact known concentration of analytes
- Used to adjust systems to
an established reference
method - How? The instrument
measures the calibrator and
adjusts the signal to match the
given values. Plotting the signal
on the Y-axis versus analyte
conc. on the X-axis creates a
calibration curve. The purpose
of a calibration curve is to
establish the relationship
between the conc. of analyte
and the magnitude of the signal
given by the measuring device.
(linear or non-linear)
Standards
can be considered calibrators, but they are usually a pure chemical whereas
calibrators usually have several exact known analytes in a similar matrix to what is being tested
(ie. Serum or plasma).
Controls
are substances which contain one or more known analytes which are used to verify the
accuracy and precision of measurements. They can be biological or synthetic in nature.
- A patient-like material ideally made from human serum, urine or spinal
fluid. - Should be tested in the same manner as patient samples
- Known ranges
- Usually contains many different analytes in one bottle
- Good laboratory practice requires testing normal and abnormal controls
for each test at least daily to monitor the analytical process - QC statistics are recorded on LJ charts, and Westgard Rules are
considered
Precision
refers to the reproducibility of a result or how often the same result is generated by
repetitive testing.
* Can indicate random errors but it does not indicate that an instrument is
reporting the correct result, which is accuracy
For example, a technologist may be required to pipet 2 mL of deionized water
into 30 test tubes. If the technologist’s skill is precise, all 30 tubes will contain exactly 2 mL of
water.
Accuracy
Who are the only one who has it
infers the correctness or closeness with which the measurement comes to the true
value.
Only calibrators/standards have accurate or true values. For example, a solution may be
known to contain 2.5 to 2.9 mmol/L of a substance. If the substance is analyzed, a determined
value of 2.6 mmol/L would be considered accurate, while a value of 4.0 mmol/L would not be
accurate.
Reliability refers to a
degree of accuracy and precision over an extended period of time under variable conditions.
-Accuracy & precision reflect how well the test method performs day to day in the lab. The other two, sensitivity and specificity, deal with how well the test is able to distinguish disease from absence of disease.
For example, the VW Beetle which drove well with few problems over
several years of ownership, demonstrating accurate and precise driving capabilities, was
considered to be a “reliable” car.
Specificity
infers the ability to accurately measure one component without interference by other
components.
* Specificity is the ability of a test to correctly exclude patients who do not have a given disease.
The more specific the test is, the less false-positive results
For example, if one were interested in eating only the red candies in a box of
Smarties, one would not want to pick any other colour, such as purple, green, blue, etc. When
evaluating a method in the clinical lab we use negative controls to assess specificity.
Negative controls
are samples which are lacking in the component we are interested in detecting.
If the method is specific and a negative control is tested, our test result should be
negative.
Sensitivity
infers the ability to measure small amounts of a component.
- Sensitivity is the ability of a test to correctly identify patients who have a given disease or
condition. The more sensitive a test, the less false-negative results will be produced - If a test is 90% sensitive then 10% of people tested could be false-negative or found normal.
Positive controls
contain a small concentration of the component we are interested in detecting. If the method is sensitive and a positive control is tested, our test result should be positive.
Error
is inexactness in measurement; for example, estimating the money in your wallet as $100
when it truly is $85.04. In the lab we are concerned with analytical errors, which are errors that
occur during the analysis of a sample. Analytical errors are divided into systematic and random.
Analytic period: Systematic errors
This is a change in what
are associated with a change in accuracy. Systematic errors affect all theresults of a method in either a positive or negative fashion. Such errors will be of the same magnitude and in the same direction and are generally predictable, identifiable and correctable.
For example a technologist might introduce a systematic error into a spectrophotometric method
by erroneously setting zero absorbance using the first standard instead of distilled water. This
will cause all consequent absorbance readings to be off by the amount of absorbance of the first
standard
common causes of systematic errors
- stray light
- scratches on cuvettes
- improper sample storage
- inaccurate standard graphs
- outdated reagents
- instruments which have an incorrect zero Absorbance
Random errors
Change in what
are associated with a change in precision. Random errors are more difficult to
monitor in the lab because they happen without prediction or regularity. Random errors can be
due to carelessness and inattention
Common causes of random error in the clinical laboratory are:
- transcription errors
- inaccurate patient identification
- inaccurate patient or sample preparation
- dirty glassware
variation
Variation
is change or deviation in results that can have a significant effect on the precision and
accuracy of lab results. The lab attempts to control variation by evaluating methods through
statistical means.
Variations in sample analysis that labs must regularly deal with include:
- physiological variations such as age, sex and diet
- differences in technique of specimen collection
- differences in technique by those performing the test method
Qualitative variables
are observable characteristics such as urine colour and clarity.
Quantitative variables
refer to numerical observations such as length of time of a method, the
concentration of an analyte in a sample or the size of an object
Variables are classified into two types: discrete and continuous
1) Discrete variables
are those observations which can be counted.
For example, the number of
pennies saved in a day or the number of test tubes a lab uses in a month.
2) Continuous variables
are those for which any value within a particular range is possible.
For example, a 19 year old individual is somewhere between 19 years, 1 day old and 20 years. A 5
mL volumetric pipette may measure somewhere between 4.99 and 5.03 mL.
A population is a
large body of data which does not have to be finite. It is impossible to
measure each member of a population; therefore we evaluate a sample to make inferences about
the population. The sample is any part of the population and should be a random representative
of the population. In this way, every member of the population has an equal opportunity of
being chosen
T/F When we receive a new lot # QC it is analyzed for several days (usually along side the current lot#) to determine the control range (>20 samples/20 days of each Low, Normal, or High controls)
T
Measurement of Variability affected by
-operator technique
-environmental conditions
-performance characteristics of the measurement
3 Measures of Central Tendency
Mode, median, mean
mode
the value which occurs with the
greatest frequency
median
the value at the center or
midpoint of the observations
mean
the calculated average of the
values
-The mean is the lab’s best estimate of the analyte’s true value for a specific level of
control
Normal Distribution
- When data have a normal spread or distribution, the
median, mean and mode are similar or identical values - All values symmetrically distributed around the mean
- Characteristic “bell-shaped” curve
- Assumed for all quality control statistics
To determine level of
precision the lab is performing
at…the dispersion of the data
about the mean is considered
Standard Deviation (S) or SD
Principle measurement of
- SD is the principle measure of variability used in the laboratory
- It is a statistic that quantifies how close numerical values (QC values) are in relation to
each other. - Precision is often used interchangeably with standard deviation
- Used to monitor on-going day-to-day performance
- = the standard (or typical) amount that scores deviate from
the mean
Consistent SD
low standard deviation, low imprecision
Inconsistent SD
high standard deviation, high imprecision
CV formula
SD/ mean x 100= x.x%
the lower the better
ACCEPTABLE CV for Manual methods is
less than or equal to 10%
ACCEPTABLE CV for Instrument methods
3.0% or less
CV
The better the x the x cv
- The better the precision the lower the CV
- CV is the great statistical equalizer
- Measure of relative variability
4 Frequency Distribution Curves
- Data table
- Frequency table
- Bar graph*
- Histogram*
Gaussian or Normal Distribution
It is the key to the statistical quality control
* The mean, median and mode are identical
* Used to verify the on-going performance of analytical systems
+ 1 SD 68% of the time
+ 2 SD 95% of the time
+ 3 SD 99.7% of the time
How can we relate Gaussian to
Standard Deviation and Probability?
- We can predict that the data will fall within a specific
percentages of the mean on the Gaussian curve - 95% of the results/data points will fall within + 2SD
T/F random errors = SD increase= shit in precision
T
T/F systemic errors lead to mean change = shift in accuracy
T
What is a reference range?
= range of results for clinically 95% of healthy people
* If they fall outside this reference range this indicates a possible disorder/clinical issue
* It is the range that a patient’s results should typically fall within if they are healthy
Control range
= the acceptable range of a known control sample for an analyte in
order to monitor the precision and accuracy of our analytical system
- A reference range is dependent on the population being tested
- And also dependent on the individual being tested
- What does this mean?
There are physiological variables, laboratory variables, and/or patient indicators
For most lab tests we do not just give out
reference intervals unless they are in a
patient result chart why?
Variance between laboratories
When to re-evaluate
Reference ranges?
- Method is modified,
removed or added - Method becomes
automated - Population changes
significantly - Method changes entirely
Calibrators/Standards
- Multiple calibrators/diluted standards in increasing
concentrations are measured and results are
plotted on a graph/curve which is used to
extrapolate or calculate the concentration of
analytes in QC and patients - Automated analyzers store the calibration data
- Frequency of calibrations depends on the analyzer
and the methodology (set by manufacturer)
Common Reasons why calibration fails?
- Improper mixing of calibrator
- Improper constitution of calibrator
- Improper mixing in instrument
- Instrument sample delivery issue
- Change in calibrator lot #
- Contaminated reagent/calibrator
- Expired reagent/calibrator
- Impure water system
When to Calibrate
- New lot # reagent loaded on analyzer
- When required as per manufacturer (intervals)
- When troubleshooting (QC is out)
- After maintenance procedures
- QC is ALWAYS run after calibration
Quality Control Testing
* The ISO calls this process, ‘Ensuring the Quality of
Examinations
This is achieved by employing error detection
mechanisms to safeguard the examination or
analytical phase
Criteria for Control material
- Patient-like material (human serum, urine, or spinal fluid)
- Have a known quantity of analyte present to cover spectrum
of possible results test menu (low, normal, high) - Must be stable for extended time
- Material should be reproducible
* Vial to vial homogenous
* Reconstitution must be the same - Easy to use
- Contain all constituents you need to measure
* Ex. Every test you will run on a patient must be present in the control samples
Commercial Controls
- Purchased as kits or boxes with several vials of lypophilized material
- Each box has a lot#
- A specific amount of diluent added to each vial to reconstitute
- Material resembles human material
- All pre-tested for presence of Hepatitis and HIV
Blind Duplicate Patient samples as controls
- A patient sample may serve as a control
- Usually qualitative analysis
liquid stable vs lyophilized IQCs
ready to use vs need additions bcs they are free dries
advantages vs disadvantages of commercial controls
Assayed vs nonassayed
assayed prior by manufacturer and unassayed not tested prior
assayed: expensive, used to evaluated accuracy and precisions , avoids lab erroes
unassayed: cheaper, precision only, avoids manufacturer errors
in house controls
uses pooled sera
covid electronic controls vs internal control
if the electronic control was working vs if the sample was enough
how many variables for control
at least 20-30
outlier
outside 3SD
Every QC system or lab should have at least 2 (preferably 3)
levels of controls that are run daily (low, normal, high)
* Why?
sick patients will have these diff levels
QC range is established now you have to monitor QC in the lab
* QC chart used is called
Levey-Jennings or LJ chart
20-30 day period 1-3Sd and mean
1 control leverl on 1 chart
What happens if some
data points fall outside
the Gaussian pattern
(3SD)?
The Gaussian curve
would widen…indicates what error
widen=random error
What if 68% of
values are shifting to
one side?
Gaussian curve has
shifted to one side of
mean and indicates
shifted= systemic errors
T/F LJ is basically a Gaussian on its side separated by time as a frequency
T
LJ chart 3 must have rules in labs
1, every lab has a graph systme
2, daily control values are plotted vs time
3, lines are drawn to conncet
T/F * Precision and long-term accuracy are confirmed on a LJ chart
by control values that remain clustered about the mean with
little variation in the upward or downward direction
T
What to do after the results are plotted on LJ?
- The technologist needs to assess the quality of the run
- The technologist should look for systematic error and
random error - Long term inaccuracy is identified on LJ by either a trend
or a shift - Trends and shifts are systematic errors
Systematic Error
A change in the mean of the control values
* Change in the mean may be gradual and demonstrated as a trend in control values
* Or it may be abrupt and demonstrated as a shift in control values
review shift vs trend causes image
There is unacceptable (unexpected)random error that is any
data point outside the expected population of data
outside 3sd
shift
control on one side of the mean 6 consecutive days
trend
control moving in one direction heading toward an out of control value
Advantages of LJ
- Good visual representation of precision and accuracy
- Easy to interpret
Disadvantages of LJ
- Time to maintain data
- Must be plotted at the time of assay and in order
- Acceptable conditions must be met or prevent release of patient results
- Westgard rules provide some practical solutions to the disadvantages
of LJ
There are usually more than one test/analyte tested in each
bottle of QC… what if you run all the tests that are on your
analyzer on level 1 and level 2 QC….and all the tests are “in
control” and acceptable except the glucose????
report only if the test is not gluose related
this indicates there is something with the reagnet, the QC bottles are fine
