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41 Cards in this Set
- Front
- Back
Refers to the degree to which a set of inherent characteristics of a product, services, or process fulfills requirements and meets established standards |
quality |
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Closeness (mv) to (rv) |
accuracy |
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Ability of a laboratory to consistently produce accurate and precise results |
reliability |
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Capability to link measurements results to ensure validity |
traceability |
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adherence to establish standards, protocols and regulations relevant to lab activities |
compliance |
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to ensure accurate and reliable results |
calibration and maintenance |
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accuracy + precision |
reliability |
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Records and data |
documentation |
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Refers to the overall process used to ensure that laboratory results meet the requirements for health care services to patients |
quality management system |
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12 quality system essentials |
- organization - customer focus - facilities and safety - personnel - purchasing and inventory - equipment calibration and maintenance - process management - documents and records - information management patient and sample identifier - nonconforming event management - assessment - continuous improvement |
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Leadership and management |
organization |
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Survey and feedback |
customer focus |
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Lab design, floor plan and measurements |
facilities and safety |
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RMT, CMT, HOL (pathologist), lab analyst and lab tech |
personnel |
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Reagents and calibrators |
purchasing and inventory |
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QA & QC |
process management |
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Laboratory Information Management System (LIMS) |
information management patient and sample identifier |
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Any events that have a negative impact must be corrected |
nonconforming event management |
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PT/EQA |
assessment |
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to check the reliability of a laboratory |
assessment |
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Plan, Do, Check, Act (PDCA), Six Sigma and LEAN |
continuous improvement |
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It is a process that focuses on providing assurance that quality requested will be achieved and attained the best possible product or service to patients |
quality assurance |
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quality assurance measure designed to ensure that laboratories procedure are accurate and reliable results |
proficiency testing |
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Laboratory must support an optimal path of workflow by allowing processes that yield efficient sample handling while minimizing error |
path of workflow |
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✓ Specimen handling, collection and transport ✓ Patient preparation ✓ Fasting FBS (6-8HR) TAG (12-14HR) CHOL (8-10HR, No Fasting) |
pre-analytical |
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Testing process |
analytical |
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Recording results and data interpretation |
post analytical |
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A process to periodically examine a measurement procedure to verify that it is performing according to preestablished specifications |
quality control |
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✓ Measures the analytical phase (process flow) ✓Post analytical phase ✓Qc sample are measured as same manner as clinical samples (patient samples) ✓Qc sample (manmade) |
quality control |
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✓Background component of sample other than the test to perform ✓CSF ✓Urine ✓Serum ✓Plasma |
matrix |
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✓New batch rgts •Solution of known concentration •Must have the same matrix as sample •Can be run in single or multiple parameters •Has to be purchased separately •Expensive ✓Liquid ✓Lyophilized (powder) |
calibrators |
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•Solution of known concentration •Matrix may or may not be the same as sample •Provided with kit •Cost effective |
standards |
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•Substance having similar composition as sample used to monitor the status of analysis •Matrix is the same with the sample •Test if the analyzer after calibration is giving satisfactory results or not •They have value in range (low, normal, high) •Can be obtained from the reagents or instrument supplier or third party control •IQC daily •EQC once a month |
control |
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Essential in laboratory analyses, helping to identify, quantify, or modify the properties of substances |
reagent |
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differs depending on the test being performed |
reagents |
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•Substances of interest being analyzed or measured •Hema •CC •CM |
analyte |
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goal of quality control |
•Providing laboratory with confidence by: 1.Detecting errors 2.Evaluating errors 3.Correcting errors |
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goal of quality control is to provide laboratory with confidence by: 1. Detecting errors 2. Evaluating errors 3. Correcting errors due to: |
1.System failure 2.Environmental conditions 3.Operator performance (rmt) = before reporting the patient results |
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Most common presentation for evaluating QC results |
levy jennings chart |
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Allows a quick visual assessment of method performance, including trend detection |
levy jennings chart |
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represents the target (or expected) value for the result, and SD lines represent the expected imprecision for the method |
mean value |