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119 Cards in this Set
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System of ensuring accuracy and precision in the laboratory |
QUALITY CONTROL |
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Color of standard solution |
COLORLESS |
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Color of Control solution |
Yellow |
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Color of icteric Samples |
Dark yellow or orange 🍊 |
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Resembles patient serum and it ensures reliable and correct results |
Control Samples |
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Sources of Control sample |
Human Base control sera Bovin based control Sample |
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Criteria for human base control sera |
non-infectious sample non- icteric sample non- Hemolyze sample |
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Why is Bovin based control sample is commonly used for making control sera? |
Because Cow goat sheep have the same biochemical analyte as humans. |
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Known |
Control |
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Sample |
standard Abnormal standard Control standard |
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Formula for Concentration of Unknown |
Cu= ( Au / As ) X Cs Au ( absorbance of Unknown As (absorbance of sample) Cs (Constant) |
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Ensures sensitivity and specificity in clinical chemistry section. |
Analytical method |
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Measures smallest concentration |
Sensitivity |
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Measures only the analyte of interest |
Specificity |
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Nearness or closeness of the assayed value to the true or target value |
Accuracy |
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To give repeated results on the same sample |
Precision or reproductibility |
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Method is easily repeated |
Practicability |
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Detect the proportion of individuals with the disease |
Diagnostic sensitivity (+) |
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Detect the proportion of individuals without the disease |
Diagnostic specificity ( - ) |
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Control - Normal , Abnormal ; values are known and given , 1 control |
Known Samples |
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Known analytical solution and most specific solution . |
Standard |
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Types of analytical error |
Systematic error and Random error |
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Analyses of the control samples together with the patient specimens |
Intralab QC (internal QC) |
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involves proficiency testing programs that periodically provide samples of Unknown concentration to participating clinical laboratories. |
Interlab QC (External QC) |
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Short term basis |
Intralab QC (internal QC) |
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Long term basis |
Interlab WC (External QC) |
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Primary role of interlab QC |
To ensure release of current patient results. |
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Other name for Abnormal control |
Pathologic Control |
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How to know if the patients has abnormal results ? |
Hyper values |
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How many samples in Internal QC? |
2 control samples 3 known samples |
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Purpose of External QC |
Maintaining long term accuracy |
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Purpose of Internal QC |
Daily monitoring of accuracy and precision of analytical methods. |
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Primary Role of External QC |
To compare performance between laboratories |
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Reference laboratory for Clin Chem Assay. |
Lung Center |
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How many sample are being tested that are given by the reference laboratory to a clinical chemistry laboratory for testing? |
more than 8
to be exact 12 samples |
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how many samples that the reference laboratory gave to the clin chem lab do they test ? |
1 sample per month usually it is tested in the morning |
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In a routine test in Intralab QC how many test can they generate ? |
20 different test in 24 hours |
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Routine test in clinical laboratory |
Glucose Cholesterol TAG Uric acid Creatinine BUN
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GCTUCB |
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Is a known analytical sample with several known analytes |
Control Sample |
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Is a known analytical sample with only one component. |
Standard Sample |
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Most specific Analytical sample |
Standard Sample |
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It has been adopted by CAP in an effort to improve patient care through quality laboratory practice |
ISO 151189 : 2007 |
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Component of analytical method |
Reagent Equipment Procedure |
Malamig at dito nilalagay |
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Objective of quality control |
check stability of machine check quality of reagents check technical errors |
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Revoked , Substituted, Interchanged |
Communitability |
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Characteristic of an Ideal QC material |
Resembles human sample Inexpensive and stable for long periods No communicable diseases No matrix effects/ known matrix effects With known analyte concentration (assayed controled) Convenient packaging for easy dispensing and storage |
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Ideal control/ reference limit is between |
+/-2SD |
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CLIA (Clinical Laboratory Improvement Amendment) |
For routine test run control test atleast once every 24 hours For blood gas measurements, Run control test every 8 hours. |
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Errors encountered in the collection, preparation and measurement of samples, including transcription and releasing of laboratory results. |
Variations |
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Type of error which varies from sample to sample |
Random Error/ Imprecision/ Unpredictible error/ Indeterminate error |
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A measure of Imprecision or random error |
SD and CV |
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influences observation consistently in one direction |
Systematic Error/ Predictable error/ determinate error/ Inaccuracy |
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First step in method evaluation |
Precision study |
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to study Imprecision or random error |
2 control solutions are run twice a day in a 10-20day period |
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Is the most error free means of requesting laboratory tests. |
Online computer input |
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Where does most of the error occur in the laboratory? |
Preanalytic and postanalytic stages. |
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Science of gathering, analyzing, interpreting, and presenting data. |
Statistics |
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Most important measure of accuracy |
Mean |
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Measures dispersion, Most common measure of precision |
Standard deviation (SD) |
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Measures reproductibility of the assay, Measures Precision of an assay, |
Coefficient of Variation (CV) |
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Index of precision |
Coefficient of Variation (CV) |
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other name for CV |
Relative Standard Deviation (RSD) |
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General chemistry assay |
Used 2 levels of control solutions ( norm & ab Ctrl) 3 levels ( high, low, normal) |
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Ultimate goal of proficiency testing |
Ensure our clinicians that patient results are accurate |
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Purpose of quality control chart |
observe analytical errors and observe accuracy and precision of every test |
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Bell shape curve |
Gaussian Curve |
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Where does all of the reference value/limit come from? |
+/-2S |
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Method for CUSUM |
V-mask |
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A quality control chart that requires computer implementation |
Cumulative Sum graph (CUSUM) |
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Quality control chart that gives the earliest indication of systematic error (trend)? |
Cumulative Sum Graph |
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QC chart that compares result obtained from high and low control serum from different laboratories. |
Youden/twin Plot |
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QC chart that detects both systematic and random error. |
Youden/twin plot LJ chart |
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Most common widely used QC chart in clinical laboratory. |
Shewhart Levey-Jennings Chart |
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QC chart that allows laboratorians to apply multiple rules without the help of a computer. |
LJ chart |
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Errors observe in LJ chart |
Trend Shift Outliers |
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Gradual loss of reliability in the test system |
Trend |
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Main cause of trend |
Deterioration of reagents |
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how many days of either increase or decrease rssults is considered to be trend? |
Six consecutive days |
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Sudden change in the test performance |
Shift |
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Formed by control values that distribute themselves on one side or either side of the mean. |
Shift |
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Main cause of shift |
Improper calibration of instrument |
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Highly deviating values |
Outliers |
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error in LJ chart that is beyond +/-2s |
Outlier |
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Warning rule |
1²s |
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Rejection rule |
1³s |
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last 2 controls exceed either the mean +/- 2SD |
2²s |
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last four (or any four) consecutive control results exceed either mean +/- 1SD |
4¹s |
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the range or difference between the highest and lowest control result within an analytical run exceeds 4s |
R⁴s |
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Seven control measurements in the same direction |
7t |
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3 consecutive control measurements exceed the same mean plus 1s or mean minus 1s control limit. |
3¹s |
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West guard rule is a chart ? True of False |
False, it is a rule |
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Control Values are composed of what? |
Mean and SD values |
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six sigma level that has a DPMO of 66,800 |
3 sigma |
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six sigma level that has a DPMO of 6210 |
4 sigma |
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what sigma level is considered as world class? |
6 sigma |
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what is the efficiency of 5 sigma ? |
99.9770% |
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formula for six sigma |
sigma-metric= (TEa-Bias) / CV TEa= Total Error Allowable CV= (SD/Mean) X 100 |
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six sigma cetification can be obtained through a accreditation body like ? |
American Society for Qaulity (ASQ) |
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supports change in management |
six sigma White belt |
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Support project teams |
six sigma YELLOW BELT |
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Provides training |
six sigma BLACK BELT |
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Leads projects |
six sigma GREEN BELT |
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Highest level of six sigma achievement |
six sigma MASTER BLACK BELT |
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System for reducing watse especially in production or manufacturing process. |
Lean system |
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In lean system it utilizes 5S what does it stand for? |
5S Sort Set in order Shine standardize Sustain |
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In Lean system it utilizes PDCA what does it stand for? |
PLAN DO CHECK ACT |
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focuses on work flow action |
Lean system |
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Utilizes fewer resources, reduces costs, enhances productivity, promotes staff morale, and IMPROVE THE QUALITY OF PATIENT CARE. |
"Lean Clinical Laboratory" |
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Difference between the Average measured value and the true value |
Bias/mean |
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Analysis of a single patient sample using 2 or more analyzers |
Round Robin Analysis |
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In CLIA regulations how many time in a years should the agreement between the methods be evaluated? |
(2) Twice a year |
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Analytical testing performed outside the confines of the Central laboratory, usually by nonlaboratorian personel (nurses, respiratory therapist, etc.) |
Point of Care testing (POCT)/ Decentralized Testing |
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Most commonly used POCT |
Blood glucose meters |
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Internal and External QC of POC instruments should be done |
ISO 22870 |
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If the patient is under the Age of 60 years try, to attribute all the change w/in normal laboratory findings to a single cause.
Only if there is no possible way to correlate all abnormal findings the posibility of MULTIPLE DIAGNOSIS BE ENTERTAINED. |
Osler's rule |
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A value obtained by observation or measurement of a particular type of quantity on a reference individual. |
Reference limit/ Reference Interval/ Reference Value |
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Pair of medical decision points that extend the limits of test results for certain heathy population |
Reference limit/ Reference Interval/ Reference Value |
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how many individuals are needed to derive reliable estimates of reference intervals? |
ATLEAST 120 Individuals |
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For verification of already existing and established reference intervals CLSI permits how many specimen/individuals? |
20 subject specimens/ individuals |
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