Quality Control Flashcards
_________________(ISO)
the ___________________ (CLSI)
International Organization for Standardization
Clinical and Laboratory Standards Institute
quality management system can be defined as “ _______ to ________ an organization with regard to quality”.
coordinated activities
direct and control
ISO standards group laboratory processes into ______,______, and ________ categories.
Comparable terms in current laboratory use include: ______,______, and _______ processes; or _______,______, and _______ processes.
pre-examination, examination and post-examination
pre-analytic, analytic and post-analytic
pre-test, test and post-test
entire set of operations that occur in testing is called the __________
path of workflow.
The path of workflow begins with the ______ and ends in ________________
patient
reporting and results interpretation
The concept of the path of workflow is a key to the _________ or ________, and must be considered when developing quality practices.
quality model or the quality management system
quality management system model was developed by _____
CLSI
quality management system model is not compatible with ISO standards.
T/F
F
It is fully compatible with ISO standards.
Implementing a quality management system guarantees an error-free laboratory
T/F
F
It may not guarantee an error-free laboratory, but it does yield a high-quality laboratory that detects errors and prevents them from recurring.
Organization
In order to have a functioning quality management system, the structure and management of the laboratory must be organized so that quality policies can be established and implemented.
There must be a strong ___________ (_____________ is crucial) and there must be a mechanism for _______ and _______
supporting organizational structure
management commitment
implementation and monitoring.
Personnel
The quality management system addresses many elements of personnel _______ and _______, and reminds us of the importance of ______ and _____
management and oversight
encouragement and motivation.
The most important laboratory resource is ____________
competent, motivated staff.
Equipment
Many kinds of equipment are used in the laboratory, and each piece of equipment must be functioning properly.
________ the right equipment, _____ it correctly, ensuring that new equipment works properly, and having a system for _______ are all part of the equipment management programme in a quality management system.
Choosing
installing
maintenance
Purchasing and inventory
The management of ______ and ——— in the laboratory is often a challenging task.
However, proper management of purchasing and inventory can produce _____ in addition to ensuring ________
reagents and supplies
cost savings
supplies and reagents are available when needed.
The procedures that are a part of management of purchasing and inventory are designed to ensure that all reagents and supplies are _______, and that they are ___________________
of good quality
used and stored in a manner that preserves integrity and reliability.
Process control
These factors include quality control for testing, appropriate management of the sample, including collection and handling, and method verification and validation.
The elements of process control are very familiar to laboratorians; ______ was one of the first quality practices to be used in the laboratory and continues to play a vital role in ensuring accuracy of testing.
quality control
Information management
The product of the laboratory is _____, primarily in the form of ______.
Information (data) needs to be carefully managed to ensure ______ and ______, as well as accessibility to the laboratory staff and to the health care providers.
Information may be managed and conveyed with either paper systems or with computers.
information
test reporting
Documents and records
Many of the 12 quality system essentials overlap. A good example is the close relationship between “Documents and records” and “ ________ “.
Documents are needed in the laboratory to inform how to do things, and laboratories always have many documents.
Records must be meticulously maintained so as to be accurate and accessible.
Information management
Occurrence management
A system is needed to ______ these problems or occurrences, to ______ them properly, and to ____ from mistakes and ———— so that __________
detect; handle
learn
take action so that they do not happen again.
An “occurrence” is ______________
an error or an event that should not have happened.
Assessment
The process of assessment is a tool for examining laboratory performance and comparing it to standards, benchmarks or the performance of other laboratories.
Assessment may be internal ( ______________ ) or it may be external (__________).
Laboratory quality standards are an important part of the assessment process, serving as benchmarks for the laboratory.
performed within the laboratory using its own staff
conducted by a group or agency outside the laboratory
Process improvement
The primary goal in a quality management system is __________ of the laboratory processes, and this must be done in a systematic manner.
There are a number of tools that are useful for process improvement.
continuous improvement
Facilities and safety
Many factors must be a part of the quality management of facilities and safety.
These include:
Security—which is the process of _______________
Containment—which seeks to minimize risks and prevent _____________
Safety—which includes policies and procedures to prevent ___________
Ergonomics—which addresses facility and equipment ______ to allow safe and healthy working conditions at the laboratory site.
preventing unwanted risks and hazards from entering the laboratory space.
hazards from leaving the laboratory space and causing harm to the community.
harm to workers, visitors and the community.
adaptation
laboratory is a service organization
T/F
T
The principles of statistically analyzing QC were initially applied to the clinical laboratory in the —-s by _________
1950
Levey and Jennings
QC material
Variation between vials should be (minimal or maximal?) so that differences seen over time can be attributed to the ________ and not variation in the _____
Minimal
Analytic method itself
QC material
Specimens analyzed for QC purposes are known as _______ and must be available in sufficient quantity to last at least ____ and aliquoted in ___ form.
QC material
A year
Stable
QC materials should be the same _—— as the specimens actually to be tested. For example, a glucose assay performed on serum should have QC materials that are prepared in serum.
Matrix
General chemistry assays generally use ____ levels of control, while immunoassays commonly use ____.
two
three
Nowadays, which happens more?
laboratories purchase control materials from companies that manufacture products for QC
Or
prepare the materials themselves.
Today, laboratories more often purchase control materials from companies that manufacture products for QC, instead of preparing the materials themselves.
QC materials
Control material concentrations should span the _____ range of the analyte at appropriate decision levels.
clinically important
QC materials
These materials are often ______ (______ to ——— ) for stability and can be reconstituted
lyophilized
dehydrated to powder
Control materials must be purchased with previously assayed ranges.
T/F
F
Control materials can purchased with or without previously assayed ranges.
common method to assess the determination of control materials over time is by the use of a ____________
Levey-Jennings control chart.
Control charts graphically represent the ________ values of a control material over time in the context of the _____ and _____ control limits. And when that value falls with the control limits, it can be interpreted that _____________
Points falling outside the control limits may suggest that —————-
observed; upper and lower
the method is performed adequately.
problems may be developing.
Imprecision is the __________ about the mean due to ______.
Inaccuracy is the difference between a _______ value and its _____ value
dispersion of repeated measurements
analytic error
true
Systemic error: error always in ______
One direction
Constant error: type of systemic error in the _____ direction and magnitude. The magnitude of change is _______ and not dependent on the ________
sample; constant
amount of analyte
Proportional error: type of ________ where the magnitude changes as ___________
Error is depending on _________
systemic error
a percentage of the analyte present
analyte concentration
Total error = ________ + _______
Random error
Systemic error
Operation of a Quality Control System
The QC system in the clinical laboratory is used to monitor the analytic variations that can occur.
The QC program can be thought of as a three-stage process:
1. Establishing ________ of variation for each analytic method
2. Using these limits as criteria for ______ the QC data generated for each test
3. Taking action to ______ when indicated a. ___________
b.________
c.__________
allowable statistical limits
evaluating
remedy errors
Finding the cause(s) of error
Taking corrective action
Re-analyzing control and patient data
In general, monitoring of analytic methods is performed by assaying __________ materials and comparing the lab’s _______ values with the manufacturer’s _____ values.
stable control
determined; expected
The expected values are represented by intervals of acceptable values with upper and lower limits, known as _______
control limits.
When the expected values are within the control limits, the operator can be assured that __________________
However, when observed values fall outside of the control limits, the operator ——————- and _________ before potentially erroneously reporting patient results.
the analytic method is properly reporting values.
can be notified of possible problems and further analysis of the method can be made
The “multirule” procedure was developed by __________ to further judge whether control results indicate _________ situations.
Westgard and Groth
out-of-control
Multi rule procedure
These rules established a criterion for judging whether an analytic process is out of control.
To simplify the various control rules, Westgard and Groth used abbreviations for the various control rules.
Control rules indicate the number of ____________, followed by the _____ in subscript.
control observations per analytic run
control amount
Multi rule procedure
If a method is in control, ideally _______ control rules should be violated and the analytic run will not be rejected.
none of the
In addition to daily QC practices, laboratories are required to participate in _______________ programs which is another tool in the ongoing process of _________.
external proficiency testing
monitoring test performance
External Quality control: Proficiency testing
For a proficiency test, a series of (known or unknown?) samples are sent to the laboratory from the program offering this analysis, such as ____.
The samples are analyzed in the same manner as patient specimens, and the results are reported to the proficiency program.
Unknown ; CAP
External Quality control: Proficiency testing
The program then compiles the results from all of the laboratories participating in the survey and sends a ______ back to each participating laboratory.
Each analyte has a defined performance criteria (e.g., ______ to peer mean), where laboratories using the same method are graded by comparing them with the group.
performance report
+/- 3 SDs
Proficiency testing allows each laboratory to compare its test results with those of other laboratories that use the ____________ and ________
same or similar instruments and methods.
External Quality control: Proficiency testing
Laboratories may be asked to submit information that could include ______ and _____ proficiency testing reports, QC and equipment monitoring, analysis and _____ action of the problem that caused the failure, and the steps taken to ________ of patient test results.
current and historical
corrective
ensure the reliability
External Quality control: Proficiency testing
If the laboratory cannot resolve analyte testing discrepancies, the testing facility may be at risk of ________________
Besides meeting required accreditation standards, proficiency testing allows the laboratory to objectively ensure they ________________
losing the authority to perform patient testing for the analyte(s) in question.
report patient results accurately
Diagnostic sensitivity is also known as ????
Diagnostic specificity is also known as ????
True positives
True negatives
_________ can mimic pseudohyponatremia
Hyperlipidemia
Quality ______ is a subset of Quality _____
Control
Assurance
