Management and Informatics Flashcards
What are the six components of competency testing?
Direct observation of testing, Direct observation of maintenance, Monitoring result recording, Review of test/maintenance records, Practical exam (testing known samples), Problem solving skills *this has been extended to anatomic pathologists participating in peer review program
According to CMS, how many labs can one person be a CLIA director for?
5 labs *some state laws vary and may be less than this but CMS says max of 5
According to CLIA, what are the required retention times for records?
CLIA established minimum for retention of records and AP materials.
- For most, such as instrument printouts, CP reports, QC records, blocks etc., requirement is 2 years.
- For cytology slides, 5 years minimum.
- For AP slides, reports, 10 years minimum (CAP 10 yr for blocks).
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CAP suggests additional guidelines:
- cytogenetic smears, 3 y
- cytogenetic reports, 20 y
- flow cytometry 10 y
- Most blood bank records: 10 y
- QC results 5 y
- Results for deferred donors must be kept indefinitely
- Forensic reports/blocks/slides also kept indefinitely
Each test is identified by its CPT (Common
Procedure Terminology) code and this is revised each
year by who?
The American Medical Association (AMA)
When considering a budget for lab, what is 1) the most expensive thing and 2) the 2nd most expensive thing?
Most expensive is personnel (most labs account for 2/3 of budget) and 2nd most expensive is usually blood products
What are LOINC codes used for and what does LOINC stand for? What about SNOMED codes?
Currently recommended to use LOINC codes for tests
(Logical Observation Identifiers Names and Codes); also LOINC codes for clinical data.
Diagnoses use SNOMED codes (Standard Nomenclature of Disease), although clinical
diagnoses classified based on ICD (International Classification of Disease) codes (usually ICD-9 or -10)
What are delta checks?
Used in autoverification. Delta checks are a comparison of current results with past results to look for different results on the same patient; used to identify contaminated or mislabeled samples, but
most indicate changes in patient condition
What is LEAN management?
Introduced by Toyota. Process management to look at physicial steps involved in performing a job. First step in doing this is to diagram out (sometimes called “spaghetti diagrams”). Involves reviewing all steps in process, reducing unnecessary or wasteful steps. Those performing tasks are involved to simplify procedure and physical path taken to perform job activities. In laboratories, generally increases
efficiency and reduces turnaround time.
What is SIX SIGMA?
Introduced by Motorola; error less common than 6 standard deviations. For qualitative (e.g., lost samples), 3.4 in a million (106) = 6 sigma. For quantitative measures, sigma equals difference between allowable error and bias, divided by standard deviation.
What is Maslow’s hierarchy?
Five levels of need: physical (food, clothing, shelter), security, being loved or wanted usually met; ego (need to feel important) and self-actualization (doing
well, developing abilities).
In many job settings, first three easily met; job satisfaction based on how well last two needs are met.
What three groups of people does Medicare extend benefits to?
1) Age 65 and older
2) Permanently disabled
3) End stage renal disease
What is the Stark Law intended to do?
Prevent physicians from working around the direct billing requirements by setting up “shell labs” in which a lab that is owned by the physician does nothing other than refer testing out to actual laboratories and then bill Medicare directly
Note that this is different from the antikickback law which prevents physicians from providing items of value in order to induce providers or patients to spend their Medicare benefits on your lab’s services
What are the 4 major parts of the budget in a lab?
The capital budget
The personnel budget
The operating budget
The allocation budget
What are the ways that a lab ensures 1) accuracy and 2) precision?
1) Accuracy is controlled through periodic calibration
2) Precision is assessed by daily testing of QC reagents
within run precision for most analytes should run between 1-10%. Precision is expressed as coefficient of variation.
Tests may give results on different scales. Name an example for the following scales:
1) interval scale
2) ordinal scale
3) nominal scale
1) gives discrete numbers that have usual mathematical meaning (ie sodium)
2) gives a number with an assigned value (ie 1+ to 4+ on urine dipstick)
3) gives a category (ie positive or negative)
What is the TRUE or TOTAL notification time for a lab test?
Order-to-physician notification time
What are the effects of prolonged tourniquet application during phlebotomy?
Causes hemoconcentration
Which causes increased serum and plasma levels of protein, lipid, iron and cholesterol
Increase in lactate and decreased in pH
How do bilirubin, hemoglobin and lipids interfere with spectrophotometric assays?
Hemoglobin and bilirubin absorb particular wavelengths of light (Hgb = 412 nm and bili = 340-500 nm)
Lipids scatter light (block light transmission)
On a ROC curve, how do you know which test will perform the best?
The area under the ROC curve
ROC curve is generated by plotting sensitivity (true positive rate) on the Y axis and 1 - specificity (false positive rate) on the X axis for a range of different test cutoffs.
Area equal to 1 represents a perfect test whereas an area of 0.5 represents a test with no ability to discriminate
Generally speaking, an area under the ROC curve greater than 0.8 indicates good discriminatory power
Method correlation is an important step in the validation of a new lab developed test. How is this done?
A study is performed on a given amount of known concentration analytes and compared between the new test and the gold standard
Classically, the reference method is plotted on the x-axis and your lab’s method on the y-axis
If the plot is drawn classically, a slope greater than 1 implies a positive and proportional bias of your method relative to the reference method
Slope of the line represents proportional bias
If plotted classically, a y-intercept greater than 0 imples a constant positive bias
y-intercept represents constant bias
Both types of bias may coexist in a comparison study
In a regression plot, what represents proportional bias? Constant bias? Random error?
The slope of the line is a measure of proportional bias.
Intercept of the line indicates that the method has a constant bias. In the formula y = mx + b, b is a measure of constant bias. This means that all y axis values are higher than x axis values by b units.
Standard error and correlation coefficient R are measures of random error
What is the order of draw for tubes?
