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Clinical laboratory quality management
This is a mind map about clinical laboratory quality management, including management characteristics, management process, Government actions, clinical laboratory accreditation, etc.
Edited at 2024-01-20 11:16:35
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Clinical laboratory quality management
- bacteria
This is a mind map about bacteria, and its main contents include: overview, morphology, types, structure, reproduction, distribution, application, and expansion. The summary is comprehensive and meticulous, suitable as review materials.
- Plant asexual reproduction
This is a mind map about plant asexual reproduction, and its main contents include: concept, spore reproduction, vegetative reproduction, tissue culture, and buds. The summary is comprehensive and meticulous, suitable as review materials.
- Reproductive development of animals
This is a mind map about the reproductive development of animals, and its main contents include: insects, frogs, birds, sexual reproduction, and asexual reproduction. The summary is comprehensive and meticulous, suitable as review materials.
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- Outline
Clinical laboratory quality management
clinical laboratory
Does not belong
clinical pathology laboratory
Forensic Examination Laboratory
Not for clinical diagnosis and treatment
medical research laboratory
Clinical laboratories provide test information that accounts for all patient diagnosis, therapeutic effects and other medical information.
60%
Laboratory functions
Scientific, controlled, reference information (consulting services)
effect
Diagnosis
gold standard
Confirmatory test
Pathogenic microorganisms
Parasite
key indicators
Blood glucose measurement
Reference indicators
Whether patients with fever have bacterial infection and white blood cell count
deterministic meaning
Blood type test, HLA test
Other inspections cannot completely replace
Treatment
Antibiotic susceptibility testing of pathogenic microorganisms
Blood drug concentration measurement
Assessment of human health status
public health emergency
During the epidemic of infectious diseases
Management features
The core of management work
Effective integration and utilization of resources
Manage basic objects
people
Operation
Technicians work according to operating procedures
manage
by acting on the operator
Through planning, organizing, controlling, directing
Produce indirect effects on transforming the objective world
Integrate resources to achieve expected goals
manager
The most important ability
Organization and command skills
Laboratory work should have
effectiveness
accuracy
Timeliness
Economical
safety
management process
four stages
Plan, organize, lead and control
planning stage
Determine laboratory work goals and implement goal management
Long-term goal
Build a laboratory that is in line with international standards and has passed laboratory accreditation
Recent plans
Meet the conditions required for recognition
Laboratory equipment, space and personnel
Preparation of documents required for accreditation
Establish a laboratory quality system
organize
Internal human, financial, material and other resources
Effective integration and distribution
Establish organizational framework
Divide the scope of work
in principle
Purpose
Each position has work goals and tasks
overall goals remain consistent
authoritative
clearly defined
The scope and content of authority of each position
Responsibility
Each staff member is responsible for their actions
Responsibilities correspond to job authority
Grading principle
Clarity in the organizational structure
location
command uniqueness
only one superior
Coordination
lead
Establish a series of regulations, systems and standards
Lead the specific work of staff in accordance with relevant regulations
Nature
Influence
control
work done
Comparative check
Coordinate and control the entire inspection process
Modify established goals and related procedures
process
Establish control standards
The basis for effective control
Measure performance
Understand and master the actual situation of work
personal observation
Statistical Report
Written report
correct behavior
Most used
Exceptions to control
Correct long-term deviations between standards and actual work
Improve work or revise standards
Government Action
international management model
U.S. Congress
Clinical Laboratory Improvement Act Amendments
CLIA88
International Organization for Standardization
"Medical Laboratories - Specific Requirements for Quality and Competence"
ISO15189
Clinical laboratory management in my country
"National Clinical Inspection Operating Procedures"
The first standard operating procedure for laboratory medicine
"Clinical Laboratory Management Measures"
The basic idea
Definition and service content
Clarify the definition and service content of clinical laboratories
Access system and management system
Access to clinical programs and technologies
Implementation of access management for in vitro diagnostic instruments and reagents
Qualification of inspectors
Clarify requirements before, during and after analysis
Biosecurity
Government Responsibilities
Chapter One
The core of the management approach
Chapter two
General provisions for management
Meet the needs of clinical work
Starting point for laboratory work
must be adopted
Inspection items and inspection methods specified by the state
and register
Must have appropriate personnel, places, facilities, equipment, various rules and regulations and quality and safety management personnel
third chapter
Laboratory quality management
lifeline
Check quality
Chapter Four
Security management
Biosafety protection level
chapter Five
Supervision and management
Chapter Six
Supplementary Provisions
No need to unify quality control products and quality assessment plans
clinical laboratory accreditation
Certification
third party
Conformity to specified requirements for (an organization's) products, processes or services
Procedure for giving written assurances
Approval
Authority agency
The ability of an institution (laboratory) or person (authorized signatory) to perform a specific job
Procedure for granting formal recognition
in principle
Voluntary application
non-discrimination
expert review
National recognition
significance
Improve the reputation of this laboratory
The difference between accreditation and certification
Different objects
Approval
Testing laboratory or/and calibration laboratory
Certification
product, process or service
Accreditation is carried out by authoritative bodies
Certification is performed by a third party
Less authoritative than government agencies
Different properties
Approval
Authority agency
formally recognized
Different results
Recognition is proof of ability
Review of abilities
Certification is a demonstration of conformity
ISO15189
Combine "consulting services" and "continuous improvement"
as two independent elements
Put the ISO17025
Testing methods and method validation, measurement traceability, sampling, sample processing
No longer listed as a feature
assimilate into
Analysis of elements before, during and after
Current status of recognition in our country
China National Accreditation Committee for Laboratories (CNAL)
CAP accreditation in the United States
College of American Pathologists
Pathology in the United States is a big concept
Including inspection
Introduction to Quality Management
level of management
total quality management
TQM
Focus on quality
A management approach to customer satisfaction and long-term success
raw power
Meet customer requirements to the greatest extent
Quality Control
QM
Including quality system, assurance, control
Also includes the economic aspect of “cost of quality”
Focus on Economic Factors vs. Quality
true value
With the lowest expenses and higher economic returns
Meet user requirements to the greatest extent
Quality system
QS
Comprehensive and coordinated work to achieve quality objectives
Bringing together necessary quality activities
Meet laboratory accreditation requirements
necessary quality activities
staff training
Experimental process improvement
Administration and document control
All laboratory operations must be standardized
and be understood by all
quality assurance
QA
Provide a demonstration of trust
An organization's planned and systematic activities that meet quality requirements
confirmed
All planned
systematic activities
divided into
Before analysis
Analyzing
After analysis
Requires an evaluation of the efficiency and effectiveness of the entire experiment
pass
Number of specimens not accepted
Experiment time
Number of contaminated specimens
Number of reported errors
Monitor the entire experimental process
Excludes cost management and cost-benefit analysis
QC
QC
Work techniques that meet quality requirements and comply with regulations
Factors directly related to analytical measurement
Instrument use, measurement methods, etc.
include
In-house quality control
Comparative Experiment
new analytical methods
room quality assessment
Instrument maintenance
Application of technical documents and standards
advantage
Clear implementation methods and judgment criteria
objective statistical methods
insufficient
Focus on the final product
No attention was paid to the entire process of testing activities
Has the specimen been confirmed?
Is the sample volume sufficient?
Information used to report back to physicians
Quality assessment and improvement
QA&I
A systematic process of continuous improvement
Combination of quality assurance and total quality management
Elements of quality control
Facilities and environment
Inspection methods, instruments and external supplies
Inspection methods must be used that guarantee accurate and reliable inspection results
Operation Manual
Before, during and after analysis
must be saved
Copy of operating manual for starting and stopping use
Can be destroyed after two years
Establishment and validation of methods, performance specifications
Registered kit
Check accuracy and precision
self-created method
Accuracy, precision, specificity, interference factors, sensitivity, reporting range (linear range), reference interval, others
Must be kept for two years
Maintenance and functional checks of instruments and detection systems
Calibration and calibration verification
calibration
Provides a link between the test reaction and the substance being measured
known relationship process
Calibration verification
Remain stable within specified reporting range
Calibrate every six months
Calibrate when the following situations occur
Change the type and batch number of reagents
Perform major preventive maintenance or replace important components
Abnormal trends or deviations in quality control
After exceeding the acceptance limits specified by the laboratory and taking general error corrections
When problems cannot be identified and corrected
In-house quality control
IQC
Qualitative
When performing a single operation on patient specimens
Contains a positive and negative control
general design
Better specificity and higher predictive value
Quantitative
Perform each operation at least once
It is best to include two quality controls with different concentrations
Room quality control
EQA
effect
Evaluation Lab
Are they competent for the testing work they are engaged in?
Conducted by the authority organizing EQA
as an external laboratory measure
Supplementary in-house quality control
Supplement to on-site inspections by authorities
Increase patient and clinician
Trust
Purpose
Determine the laboratory's ability to perform measurements
Ability to continuously monitor
Identify problems in the laboratory
Determine the validity and comparability of new measurement methods
Increase laboratory user confidence
Identify inter-laboratory differences
Determine the performance characteristics of a certain detection method
Corrective Action
After all, record and file
Laboratory instruments or testing systems do not meet the specified operating performance requirements
Quality control and calibration results exceed laboratory established control limits
The laboratory cannot report test results within the specified time
If the test results issued are incorrect
Keep copies of original and corrected reports for at least one year
Quality control records
Elements of quality assurance
Patient testing management
Complete and unique identification of the entire process before, during and after analysis must be ensured
Application forms are kept for at least two years
Comparison of test results
The same project in the same laboratory
Different machines, different locations
relationship between results
Quality management system
constitute
organizational structure
process
Approval
Built on the idea that all work is done through processes
3 stages
Before analysis
Whether the doctor based on the patient's clinical manifestations and signs
From the perspective of evidence-based medicine
Combining laboratory capabilities and resource workload
The most direct, reasonable, effective and economical project
Collection process, storage and shipping directions
Quality control measures
Analyzing
involving
Personnel capabilities
Instrument calibration
Traceability of quantities
Method selection
Reagent matching
After analysis
test results
Reanalyze
reconfirm
program
the process and its associated resources and methods
stipulate in writing
procedural documents
It's from the staff
Code of Conduct and Code of Conduct
Classification
Administrative
Generally, procedural documents are administrative
Various rules and regulations
Responsibilities of personnel at all levels
Job responsibility system
technical
Operational documents (or operating procedures)
resource
Meet inspection work
various instruments
Equipment (including various reagents)
facility
A group of experienced and qualified technical personnel and managers
inner relationship
organizational structure
Provide organizational support
program
Continuation and refinement of organizational structure
Procedures and processes are closely related
High-quality procedural documents can ensure the completion of a high-quality process
Quality management is achieved through the management of processes
The quality of the process in turn depends on the resources and activities invested
Main points
Focus on quality planning
Focus on overall optimization
Emphasis on prevention
Focused on meeting the needs of patients and clinical care departments
Emphasis on process concepts
Pay attention to the unity of quality and efficiency
Emphasis on continuous quality improvement
Emphasis on full participation
The process of establishing a management system
Quality management system planning and preparation
The essential
beneficiary
the laboratory itself
Service objects
Laboratory resource supplier
Determination of organizational structure and allocation of resources
Preparation of quality management system documents
level
Quality Manual
procedural documents
Operational documents
Operating instructions
Quality Records
If it is 4 levels
Pay attention to the problem
Systematic
Regulatory
Value-added utility (purpose)
To achieve the purpose of improving and promoting quality management
Witness (record)
Adaptability
Quality Manual
programmatic document
core
Quality policy, objectives, organizational structure and components of quality management system
State a laboratory's quality policy
Document describing the quality system
must include
Service area
All personnel are required to be familiar with
About Good Professional Practice, Inspection Quality and Compliance with Quality Management Systems
promise
procedural documents
supporting documents
core content
work process
Shown to the department
A document that specifies a way to carry out an activity or process
Based on quality manual
Upstream quality manual, downstream operation instructions
Clarify the requirements for each element in the conversion process of each link
Who will do it? When to do it? Where to do it? How to do? What requirements are met? How to control? What records and reports are generated? What approval procedures are required?
Operating instructions
executable documents
Classification
Method class
Equipment class
Sample type
data class
Inspection methods, calibration methods, procedures and specifications for operation and maintenance of instruments and equipment.
Original sample collection manual
Patient preparation, applicant guidance, application form filling, collection methods and precautions, and storage of original samples
Standardized operating procedures
SOP document
Quality Records
Supervision documents
Records demonstrating compliance with quality requirements and effective operation of the quality system
For example, the results of regular audits and management reviews of the quality system
Records of measures or corrections taken when problems are discovered and the results achieved
Provide a basis for taking preventive and corrective measures
an objective evidence
Validate laboratory operations
The basis for continuous improvement and continuous improvement
most common
Data and information obtained from the inspection process or calibration process
important groundwork
Key elements
Classification
Relevant to the operation of the quality management system
related to technical activities
Ethics
euthanasia
support euthanasia
Conducive to patients’ own rights and interests
Helps reduce psychological pressure and financial burden on some patients’ families
Conducive to fair distribution of health resources
Starting from the principle of life value
People should respect life and at the same time accept death
No ethical support
People are helpless to the suicide of their own kind, but that does not mean it is reasonable.
Euthanasia is essentially different from suicide
Under medication
moral requirements
Fair distribution and avoid waste
What embodies the legal obligations of medicine and health is
In the face of sudden disasters (such as large-scale epidemics), obey the instructions of the health department
other
Domestic chemical reagents level two
Analytical grade reagents
for quantitative analysis
Calibration of micropipette
cannot be used for
Alcohol
Commonly used
mercury
Calibration of the sampler
Deionized water
Post-analysis quality assurance
The main work
Correct issuance of test results
consultation service
Storage and processing of test samples
Standardized management of reports
basic requirements
whole
correct
efficient
timely
Issuance of test results
Clear and unambiguous inspection markings
Name of the laboratory issuing the report
It is best to have contact information (address, phone number, etc.)
patient unique identification
Name, date of birth, gender, medical record number, ward, ward, bed number, ethnicity, etc.
Check the name of the applicant
Date of Application
Date and time of sample collection
Date and time samples will be accepted
Source or type of sample
Inspection items and results
sometimes include measurement methods
reference interval
Tips for abnormal results
Signatures of reporter and reviewer
The date and time the report was published
Other notes
May affect the quality or quantity of test results
Interpret results when needed
diagnostic report
impression
initial diagnosis
diagnosis
Results are subject to correction
Provide original and corrected results
other
We are only responsible for the test specimens for the test results.
time
At least
Sample delivery time
Inspection completion time
Result release time
basic system
Establish a system for issuing inspection reports
The quality of specimens is guaranteed
Quality control charts are drawn under completely controlled conditions
Establish a strict issuance and review system for inspection reports
Special projects (HIV, leukemia, malignant tumors, discovery of rare pathogens)
It must be issued after the director or the inspector authorized by the director meets the requirements
critical value reporting system
Regulations on the time for reporting inspection reports
Reporting deadlines should be specified
and announce it to clinical
Some should also be disclosed to patients
Guarantee patient privacy
Only sent to inspection applicants
Specimen inspection system
Store at 4℃-8℃
Biochemistry, immunity
No more than 1 week
Specimens for detecting antigens and antibodies
Can be stored for a long time
Store frozen if necessary
Troponin T
Stability time at room temperature
8 hours
whole blood glucose
Stability time at room temperature
10 minutes
blood ammonia
Stability time at room temperature
15 minutes
Hormone determination
3 days
Coagulation factors, blood cells, urine, cerebrospinal fluid, thoracic and ascites fluid
Do not save
room quality assessment
Classification
interlaboratory testing program
The organizer does not know the value
After return, compare with target value or consensus value
At the same time, it is distributed to laboratories participating in the plan.
Quality control products must be sufficiently homogeneous
Ensures that any extreme results cannot be attributed to differences in quality controls
Split sample testing plan
two or more
few laboratories
Generally used for
a laboratory
Between two similar detection systems
Divide the sample into two or more parts
Test one for each system
use
Identifying poor precision
Describe consistency bias
Verify corrective actions
known value plan
mandatory
based on law
It is mandatory for laboratories to participate
The design shouldn’t be too difficult
Failure to pass will result in penalties
voluntary
Purpose
Education and assistance to laboratories: discover existing problems through inter-room quality evaluation and help laboratories solve problems
No penalty for failure
Flexible design form
Can be easily combined
shortcoming
May not be the normal testing level of the laboratory
But the best level
It was not possible to confirm the many problems that existed before and after analysis
If participating in fewer labs
Or the reported results may have a large dispersion
The consensus value or target value is easy to deviate from the true value
Require
Must be tested in the same manner as patient specimens
Routine laboratory testing methods must be used
The number of times must be the same as that of routine testing of patient samples.
Results cannot be exchanged between laboratories
EQA samples or portions of samples cannot be sent to another laboratory for analysis
Each step of processing, preparation, methods, audits, inspections and reporting of results must be documented
Keep copies for at least 2 years
Grade requirements
Each analysis item
Failed to reach 80%
Unsatisfactory EQA results
Except for bacteriology majors
All items
Failed to reach 80%
Unsatisfactory EQA results
same analysis project
Two events in a row or two of three events in a row
Unable to achieve satisfactory results
Unsuccessful EQA results
Except for bacteriology majors
All items
Two events in a row or two of three events in a row
Unable to achieve satisfactory results
Unsuccessful EQA results
Document corrective actions
Keep for more than 2 years
Evaluation method
Content and detection frequency
At least 5 samples per event
every year at approximately the same time interval
It is best to organize three times
result
10 or more arbitration laboratories
90% consistent
The result of each analytical item must be determined by the degree to which the result deviates from the target value
Assessment agency requirements and implementation
Work content
organization and design
Operations and reporting
Confidentiality and prevention of fraudulent results
Statistical methods for processing time evaluation data
same steps
Determination of target value
known value
Certified reference value
Reference
Consensus values obtained from expert laboratories
consensus values from participating laboratories
Bias = (measured value - target value) / target value
Delta value
(Second result - First result)/Second result
In-house quality control
The purpose is to ensure stability
Precision
Good repeatability
eliminate or reduce
Random error
Coefficient of variation CV value
parameters indicating precision
Accuracy
eliminate or reduce
system error
Precision is the basis for accuracy
In-house quality control
Main comments
Precision
basic concept
random variable
observations that cannot be determined in advance
Classification
discrete variable
continuous variable
Data type
Measurement data
using quantitative methods
Generally there are units of weights and measures
counting data
Qualitative or categorical data
Level data
Group according to different degrees of a certain attribute
The number of observation units obtained for each group
The essence is counting data
the difference
Levels and Counts
There are degree differences in attribute grouping
Groups are arranged in order of size
Grades and Measurements
Not exactly quantified per observation unit
Semimetric data
Population and sample
overall
Measurements of all observation units in a specific study object
Classification
finite population
All units in the population can be identified
infinite population
sample
Randomly select some observation units from the population
representative
Samples obtained by random sampling method
Probability and Frequency
Probability
Also known as probability
A numerical value that measures the likelihood of a certain random event A occurring.
P(A)
0≤P(A)≤1
frequency
Under the same conditions, the experiment is repeated n times independently, and event A appears m times.
m/n
The frequency of occurrence of random event A in n trials
P(A)=m/n
average
The most widely used and important indicator system in statistics
Describes the central tendency, center position, or average level of a set of variable values
average
arithmetic mean
X expression
The sum of the results divided by the number of results
the average level of a set of variable values
representative
Variable values must be homogeneous
Normally distributed
Located in the center of the distribution
best reflects the central tendency of the distribution
Skewed distribution
The mean does not reflect the distribution well
Geometric mean, median
Can only reflect the central trend of the data
Combine mean with dispersion indicator (standard deviation)
Comprehensively reflect the characteristics of its distribution
the best and the worst
variance
Sample variance S2
as an estimate of the population variance
standard deviation
population standard deviation
a
sample standard deviation
s
Notice
Degree of dispersion
The larger the standard deviation, the more scattered the distribution of variable values, and the less representative the mean.
The larger s is
Often combined with the mean to describe the characteristics of the normal distribution
According to the above principles, the test results are determined
reference interval
standard deviation
Calculate the coefficient of variation and standard deviation combined with sample content
coefficient of variation
CV
Allow for imprecision
ratio of standard deviation to mean
CV=s/100%
Relative quantity, no unit
Commonly used
Compare the variability of several sets of data with widely different means
Compare the variability of multiple sets of data with different units of measurement
Compare errors in repeated measurements of multiple samples
Very poor
R
The difference between the maximum value and the minimum value
The greater the range
The more dispersed the data is
The less representative the mean is
Normal distribution (Gaussian distribution)
mean centered
Completely symmetrical
Represents the probability of occurrence of a variable value
u
Positional parameters
central tendency position
a
variation parameter
Degree of dispersion
The bigger a is
The more dispersed the data is
The smaller a is
The more concentrated the data is
average(u)
increase
The normal curve shifts to the right
Standard deviation(a)
increase
The processing quality is more dispersed
Distribution
u±1a
68.2%
u±2a
95.5%
u±3a
99.7%
application
estimated reference range
The range where 95% of normal people are
x±1.96s
QC
x±2s
Upper and lower warning limits
x±3s
upper and lower control limits
Theoretical basis for many statistical methods
Measurement error
Measurement error = measurement result – true value
truth value
natural properties
inherently uncertain
Relative error
Measurement error/true value of the measurand
Random and systematic errors
Random error
induction
symmetry
Errors with equal absolute values but opposite signs
Occurrences are roughly equal
There will be no deviation from only one side
Boundedness
Will not exceed a certain limit
Unimodality
Errors with small absolute values are more numerous than errors with large absolute values.
centered on mean
relatively concentrated distribution
system error
The difference between the average value and the true value of the measurement
Accuracy and Precision
Accuracy
Synthesis of systematic errors and random errors in measurement results
degree of consistency with the true value
Measured by inaccuracy
Precision
The magnitude of the random error
Repeatability
expressed with imprecision
CV%
Allowable total error
Total error (TE)
The sum of random error (RE) and systematic error (SE)
TE=1.96s |Bias|
95% allowable error limit
Analytical quality specifications
Performance
Allowable imprecision (CV%)
Allowed bias
Allowable total error (TEa)
most important
The amount of analytical error tolerated by medicine
Quality control products
Specimens used for quality control purposes
vial packaging
Small bottle-to-bottle differences
with test samples
same matrix
Generally freeze-dried products or freeze-dried products
Liquid quality control products are also available
Has the advantage of eliminating reconstitution errors
Can be customized or non-fixed value
Quality control chart
Generally Gaussian distribution (normal distribution)
Usually 95% (2s) to 99.7% (3s)
In control and out of control concept
1 3s
A quality control result exceeds the average ±3s control limit
out of control
Levey-Jennings quality control chart
Single value quality control chart
Observable intra-batch error (R) and inter-batch error (change in mean)
Test values of 20 pairs of quality control samples
Calculate mean and standard deviation
Set quality control limits
±2s
warning limit
±3s
out of control limit
draw
at least 20 days
Calculate mean and standard deviation
Y axis
Quality control results
Set concentration range
Including mean ±4s
Draw average, upper and lower control limit lines
X-axis
Mark the time, day, batch number, and number of quality control measurement values
The most appropriate relative time for recording quality control measurements
Westgard multi-rule quality control chart
A series of quality control rules to interpret quality control results
Sensitive to both random and systematic errors
Improved error detection probability
rule
1 2S: A quality control result exceeds the average ±2s, which is only used as a "warning" rule and activates other rules to check the quality control data.
1 3S: If a quality control result exceeds the average ±3s, it is judged to be out of control. This rule is mainly sensitive to random errors.
2 2S: 2 times exceeding 2s (in one direction), judging out of control and sensitive to system errors.
R4S: 2 times exceeding 2s (not in the same direction), the judgment is out of control, and it is sensitive to random errors.
4 1S: 4 times exceeding 1s (in one direction), the judgment is out of control and sensitive to system errors.
: 10 on one side, out of control judgment, sensitive to system errors
step
at least 20 days
It is recommended to use two concentrations of quality control materials
Each one draws it on their own quality control chart.
When two quality control results are both within 2 seconds
Reports can be issued
When 2 quality control results take more than 2 seconds
,1 3s,2 2s,R4s,
As long as one of them is out of control, no report can be issued.
shortcoming
only sensitive to results
The most direct method of quality control
Insensitive to procedures
individual patient results
clinical relevance
Relevance to other experiments
In-laboratory duplicate determination
Bias (Delta) check with previous patient trial results
3 days interval
Z-score
(measured value of quality control substance - average value of quality control substance) / standard deviation of quality control substance
Quality Control of Qualitative Assays
There is no universal quality control method
most commonly used
Add Yin and Yang control
Evaluation of the lower limit of determination of the method
Dilute the positive control serum to perform
Indoor quality control serum
Generally weak positive
Not only reacting but controlling the situation
Changes in the lower limit of determination of ring energy reactions
Evaluation of test methods
implement new method process
key step
Selection and evaluation must begin with
clinical perspective
Basic concepts and definitions
Practical requirements
Specimen type, sample size, analytical capacity, turnaround time, test menu, sample processing, analytical batch size, personnel skill requirements, cost, calibration method, calibration frequency, random processing capacity, quality control method, space requirements (reagent storage), waste disposal, safety
If it is inconsistent with laboratory requirements, it will not be used.
reliability
High accuracy
Simple method
High repeatability
High sensitivity
Performance parameters
Accuracy
Consistency between measured value and true value
Correctness
new terminology
How close the mean of a large number of measurements is to the true value
Accuracy
How close the result of a measurement is to the true value
Depends on research method
Research methods
Decisive method
related to certain absolute physical quantities
Such as quality
Common methods
isotope dilution mass spectrometry
Reference method
Higher precision methods performed by experienced workers
traceable to decisive method
Comparable method mean
of different instruments and techniques
Produced by multiple laboratories
average result
Reference laboratory mean
Mean of the same group (mean based on method group)
Same instrument and technology
Produced by multiple laboratories
average result
system error
A measure of how consistent a quantity is with its true value
Available relative coefficient evaluation
two types
Fixed and proportional errors
ROC curve
ROC curve
The closer to the upper left part of the coordinates
The larger the coverage area under the curve
The higher the diagnostic efficiency
total error
The amount of error in the final test result is greater than any individual error
Analysis scope
Ideally
calibration curve
is linear (linear range)
should be wide enough
Includes 95% to 99% of expected sample without pre-dillution
Analytical sensitivity
Slope of calibration curve
Large slope and high sensitivity
ideal method
High level of analytical sensitivity
low detection limit
Analytical specificity
Only identify analytes
Does not work on other related substances
Blank determination
No sample reagent solution
Reagent blank
Sample solutions and solutions missing key reagents
sample blank
negative control
The detection limit
Depends on blank read size
The smaller the number of blanks, the lower the detection limit.
interference
The effect of other ingredients and the effect of a group of ingredients on accuracy
Precision
The ability to produce the same value repeatedly for the same sample
Random error
Analyze at least 20 times
Within-batch precision
Usually low ground estimates of overall precision
Intraday precision
Variability obtained from repeated testing of the same sample on different days
The most realistic evaluation of performance
Recycle
A known amount of a substance is added to
The ability of the analytical method to correctly measure the analyte in real samples
Evaluate the accuracy of experimental methods and pass
Proportional systematic error
When reference methods and reference materials are limited or unavailable
Recovery testing is the only practical way to evaluate accuracy
Select analysis method
more objective criteria
Confidence interval judgment index
Estimate the confidence interval of the experimental error to carry out
performance standards
Require
The total error allowed at a specific concentration or analyte activity should be specified
Establish quality goals
include
Laboratory professional judgment
Clinician Survey
Intra-individual biological variation of analytes
The current state of the art
Bounds for reference interval score calculations
three levels
lowest performance
expected performance
Precision
Individual biological variation in 1/2 trials
bias
1/4 of the group biological variation or 1/16 of the reference interval
2 times the ideal precision
Best performance
Evaluation analysis method
Precision
Use standard deviation to evaluate
Repeat at least 20 times to measure
Correlation coefficient
It cannot be used when evaluating whether the test method is accurate.
t test
The t-value can be used to determine whether a bias is statistically significant
positive predictive value
true positive/(true positive false positive)
negative predictive value
true negative/(true negative false negative)
sensitivity
true positive/(true positive false negative)
Specificity
true negative/(true negative false positive)
Testing systems, traceability and uncertainty
Detection Systems
Complete the measurement of an inspection item
The combination of instruments, reagents, calibration materials, quality control materials, operating procedures, quality control procedures, and maintenance procedures involved
If there is manual operation
Include specific operators
Matrix and matrix effects
Matrix is also called matrix or medium
Analyze other substances and components (including solvents) other than the analyte in the sample
matrix effect
Effect of the matrix surrounding the analyte on the assay
Quality controls and calibrators and their matrices
Different from clinical samples
Different reagents produce different matrix effects
Traceability of quantities
Properties of measurement results
Application reference system
Establish or verify the accuracy of routine results
include
Reference measurement procedure
reference measuring material
Laboratories engaged in reference measurements
ideal situation
Traceable to International System of Units (SI) units
A primary reference measurement procedure is required
CGPM
International Congress of Weights and Measures
SI
International System of Units
enzyme activity unit
Kat
Cannot be traced to SI
The first
There are internationally agreed reference measurement procedures
Non-primary reference measurement procedures
There are one or more internationally agreed calibration substances
There are two kinds
such as glycated hemoglobin
The second kind
Internationally agreed reference measurement procedures
No internationally agreed calibration substances
Certain clotting factors, blood cells, HDL
Clinical examination, biochemistry
The third kind
There are one or more internationally agreed calibration substances
and valuation plan
No internationally agreed reference measurement procedures
Certain protein hormones, antibodies and tumor markers
immunity
The fourth kind
Neither
Certain tumor markers and antibodies
illustrate
premise
Routine measurement procedures with sufficient analytical specificity
The measured quantity is consistent with the quantity measured by the reference measurement procedure
Calibrator interoperability
Simultaneous determination of this calibrator and the actual sample using two measuring procedures
The degree of agreement between the numerical relationships obtained
Interoperability between two related measurement procedures
method
Both procedures measure this calibrator and a certain number of actual samples simultaneously
Need to confirm
method
Routine measurement procedures and reference measurement procedures
at the same time
sufficient quantity
Representative
taken from different individuals
actual fresh sample
Repeat measurements for each sample
using linear regression
Analyze whether the closeness of the two results is acceptable
Traceability over the entire measuring range
Traceability of points within the measuring range
Not traceable to the average
Calibrator and quality control material setting
Traceability must be ensured through existing higher-level reference measurement procedures and/or reference materials
Determined by the Joint Committee on Traceability in Laboratory Medicine (JCTLM)
WG-1
Create a program
Publication of compliant reference measurement procedures and reference materials
WG-2
Gather information on existing candidate reference measurement laboratories
Ensure the integrity and effectiveness of the measurement system
Category three
Verification of detection system performance
The detection system is traceable
verification test
Precision and accuracy testing
Confirmation of detection system performance
Recognized
Confirmation test
Precision, accuracy, reportable range of results
Evaluation of detection system performance
New detection system or any changes to original components
Evaluation test
Precision, accuracy, reportable range of results, sensitivity, specificity and reference intervals
Can be borne by the manufacturer
Just confirm or verify
uncertainty
basic concept
Measurement uncertainty
Dispersion of measured values
Classification
Standard Uncertainty (UA)
Uncertainty given in terms of standard deviation
Classification
Type A standard uncertainty (UA)
Statistical methods were used to assess
Type B standard uncertainty
assessed by non-statistical methods
synthetic uncertainty
The result is obtained from the values of several other quantities
Standard uncertainty calculated based on the variance and covariance of other quantities
Expanded uncertainty (U)
The amount of the measurement result interval
To obtain the expanded uncertainty, the combined standard uncertainty is multiplied by the numerical factor
inclusion factor
K means
K=2
Relative uncertainty (UArel)
Uncertainty divided by the measured value
Error and Uncertainty
There is a difference in all directions
evaluation process
specified to be measured
Identify sources of uncertainty
Sources include
Sampling, storage conditions, instruments, reagents, quantitative relationships of chemical reactions, measurement conditions, sample matrix, calculation effects, blank correction, operators and random effects
Quantification of components
Each potential component of uncertainty in a measurement or estimate
Should be expressed in terms of standard deviation
application
In-house quality control
Calculated standard deviation (S) and coefficient of variation (CV)
Dispersion of response data
Standard deviation S
Standard uncertainty
UA=S
Coefficient of variation (CV)
Relative standard uncertainty (UArel)
UArel=CV%
Can express precision
Compare errors in repeated measurements of multiple samples
Compare several sets of data with widely different means
Dispersion index
OCV
inter-batch coefficient of variation
OCV＜RCV
expanded uncertainty
U=2S
Relative expanded uncertainty
Urel=2CV%
Quantitative measurement methods that can only be used for indoor quality control
The best way to assess uncertainty
Before analysis
main content
Ensure the scientific and rationality of inspection project application
According to the clinician's testing requirements, correct patient preparation, and correct collection and transportation of original samples
Principles of selection
Targeted
effectiveness
population screening
more sensitive
Avoid missed diagnosis
Confirmed
High specificity
avoid misdiagnosis
Timeliness
Economy
Combination of inspection items
formed by increasing sensitivity
Parallel test
Increase sensitivity, decrease specificity
sequence test
Improve specificity, reduce sensitivity
It is formed by understanding the different functions of organs or understanding the condition of a certain disease from different perspectives.
Liver function, kidney function, hepatitis B two and a half
Formed for correct and timely diagnosis
Cardiac enzyme spectrum, troponin
Formed by understanding various aspects of patient information
Ten items of biochemistry and urine
Formed by selecting reasonable therapeutic drugs
antibiotic susceptibility testing
Patient preparation
specimen flow
The entire process starts from the collection of specimens, through preservation, transportation, pre-analysis processing, analysis, post-analysis storage and processing.
key problem
patient status
fixed factors
age, gender, ethnicity
variables
Internal factors
Such as emotions, exercise, circadian rhythm changes, etc.
exogenous factors
Effects of diet, drugs, etc.
drug
Phenytoin
Inhibit insulin secretion
other
Position when collecting blood specimens, tourniquet banding time
body position
blood lipids
Stand for 5 minutes
Increase 5%
Stand for 15 minutes
Improved by 16%
After sitting quietly for 5 minutes
more suitable
mood
Excited
Increased hemoglobin and white blood cells
sports
Tiredness, cold, hot air irritation
Increased white blood cells
diet
Alcohol
GLU reduction
Elevated TG, GGT, and HDL
smokes
Catecholamines, gastrin, cortisol, growth hormone, carboxyhemoglobin, hematocrit, carcinoembryonic antigen
rise
Decreased immunoglobulins
high protein diet
Increased creatinine and urea
Triglycerides and other lipoproteins
Fast for at least 12 hours
Hemolysis
K
The most obvious increase
P
reduce
Proper collection of specimens
The most "representative" time
In principle
When you wake up in the morning on an empty stomach
The most valuable time for diagnosis
CTNT or CTNI
After onset
4-6 hours
Take the most suitable specimen
Containers for bacterial culture must not contain preservatives
Transport of specimens
Special delivery
timeliness of delivery
Sample collection time
Safety on the way
There should be refrigeration or insulation equipment
Pre-analytical quality assurance system
complexity of influencing factors
Concealment of quality defects
If there is no obvious hemolysis. coagulation
Quality assurance is not something that inspectors have complete control over
Responsibility is difficult to determine
solve this problem
supply
Test Specimen Collection Guide
Guidelines for collection, transportation, and storage of specimens submitted for testing
Basis for standardized management
Presented to all medical staff in the hospital
Establish an acceptance system and procedures for specimens submitted for inspection
Regularly analyze problems existing in quality assurance work before analysis
Strengthen academic research